TABLET

INTRODUCTION:-Tablets may be defined as the solid unit dosage form of medicament

or medicaments with suitable excipients and prepared either by molding or by compression. It
comprises a mixture of active substances and excipients, usually in powder form, pressed or
compacted from a powder into a solid dose

WHAT IS THE DIFFERENCE BETWEEN A TABLET AND A PILL?

A tablet is a small solid mass of medicine which you swallow. If you're talking about
medicine, a pill is a round and oval capsule, and a tablet is flat and circular. "Pill" is a more
general term. It can be either a capsule or a tablet.

IDEAL CHARACTERISTCS OF TABLET:-

Seven most important Characteristic of Tablets
 Shape and Size of Tablets:
 Organoleptic properties:
 Hardness:
 Friability:
 Weight variations:
 Disintegration:
 Dissolution:
 Drug content:

GENERAL PROPERTIES OF TABLETS

 A tablet must be strong and hard to withstand mechanical shock during
manufacturing, packing, shipping, dispensing and use.
 The drug content of the tablet must be bioavailable that is, the tablet must be able to
release its content in a predictable and reproducible manner.
 The tablet must be chemically and physically stable to maintain its chemical and
physical attributes during manufacture, storage, and use.
 The tablet should have elegant product identity which is free from any tablet defect.
 Tablets must be uniform in weight and in drug content.

TYPES OF TABLETS

The various tablet types are described as follows:-

A. Compressed Tablets

Compressed tablets represent a significant proportion of tablets that are clinically used to
provide systemic administration of therapeutic agents either in an uncoated state (i.e., in their
simplest form) or in a coated state. These tablets are designed to provide rapid disintegration
in the gastric fluid following ingestion hence, allowing rapid release of the drug and,
ultimately, systemic absorption of the dosage form.
Compressed tablets are formed by compression of powdered, crystalline, or granular
materials into the required geometry by the application of high pressures, utilizing steel
punches and die.

In addition to the Active Pharmaceutical Ingredient(s) (APIs), compressed tablets usually

contain a number of pharmaceutical excipients e.g., bulking agents, disintegrants, binders,
lubricants, controlled-release polymers and other miscellaneous adjuncts such as colourants
and flavourants which serve different and specialized purpose during tablet manufacture,
storage, and use.

Examples of compressed tablets include tablets for oral, buccal, sublingual, or vaginal
administration.

B. Sugar-Coated Tablets

These are compressed tablets that have been coated with concentrated sugar solution to
improve patient’s compliance, increase aesthetic appeal, mask objectionable tastes or odours,
increase stability and/or modify the release of therapeutic agent(s). Sugarcoating was once
quite common but lost commercial appeal due to the time and expertise required in the
coating process, the increase in size and weight of coated tablets, high cost of process
validation and shipping.

The advent of film-coated tablets has also greatly decreased the use of sugar coatings due to
the improved mechanical properties of the technique. Examples of sugar-coated tablets
include Reasulf tablets – dried ferrous sulphate BP 200mg (Reagan Remedies Ltd.), Advil –
Ibuprofen tablet BP 200mg (Pfizer Consumer Healthcare), Ebu-200 – Ibuprofen tablet BP
200mg (Me cure Industries Ltd) etc.
C. Film-Coated Tablets

Film-coated tablets are conventional tablets coated with a thin layer of polymer (e.g.,
hydroxypropyl methylcellulose, hydroxypropyl cellulose) or a mixture of polymers (e.g.,
Eudragit E100) capable of forming a skin-like film. The film is usually coloured and also
impacts the same general characteristics as sugar coating with the added advantage of being
more durable, less bulky, and less time-consuming to apply. By its composition, the coating
is designed to break and expose the core tablet at the desired location in the gastrointestinal
tract.

Advances in material science and polymer chemistry have made these coatings the first
choice for formulation scientists. Examples of Film-coated tablets include Curefenac 100 –
Diclofenac potassium USP 100mg (Unicure Pharmaceutical Ltd), Valsartan 320mg Film-
coated Tablets (Actavis UK Ltd), etc.

D. Effervescent Tablets
Effervescent tablets are uncoated tablets that generally contain organic acids (such as tartaric
or citric acid) and sodium bicarbonate in addition to the medicinal substance or API. They
react rapidly in the presence of water by releasing carbon dioxide which acts as a
disintegrator to produce either a drug suspension or an aqueous solution. These tablets are
prepared by compressing granular effervescent salts (organic acid and bicarbonate) with the
medicinal substances. A typical example of this tablet type is Ca C1000 Sandoz effervescent
tablet (Novartis).

E. Enteric-Coated Tablets

Enteric-coated tablets are compressed tablets that have delayed-release properties. They are
coated with polymeric substances (such as cellulose acetate phthalate/cellulose acetate
butyrate; hydroxypropylmethylcellulose succinate; and methacrylic acid copolymers) that
resist solution in gastric fluid but disintegrate and allow drug dissolution and absorption in
the intestine.
Enteric coatings are primarily employed when the drug substance is inactivated or destroyed
by gastric acid (e.g., erythromycin) or is particularly irritating to the gastric mucosa (e.g.,
non-steroidal anti-inflammatory drugs) or when bypass of the stomach substantially enhances
drug absorption.

Example of enteric-coated tablets includes Lofnac 100 – Diclofenac sodium delayed-release

tablet USP 100mg (bliss GVS Pharma Ltd), Ecotrin tablets and caplets (GlaxoSmithKline
Beecham)

f. Chewable Tablets

Chewable tablets are big sized tablets which are difficult to swallow and thus, are chewed
within the buccal cavity prior to swallowing. They are especially useful for administration of
large tablets to children and adults who have difficulty swallowing conventional tablets or
antacid formulations in which the size of the tablet is normally large and the neutralisation
efficacy of the tablet is related to particle size within the stomach.

Chewable tablets are not conventionally used if the drug has issues regarding taste
acceptability. Examples of chewable tablets include Danacid – compound magnesium
trisilicate tablet B.P. (Dana Pharmaceuticals Limited), Gestid – tasty chewable antacid
G. Buccal And Sublingual Tablets
Buccal and sublingual tablets are small, flat, oval tablets that are intended to be dissolved in
the buccal pouch (buccal tablets) or beneath the tongue (sublingual tablets) for absorption
through the oral mucosa to produce a systemic effect. These tablets are employed to achieve
either rapid absorption into the systemic circulation e.g. glyceryl trinitrate sublingual tablets
or, alternatively, to enable oral absorption of drugs that are destroyed by the gastric juice
and/or are poorly absorbed from the gastrointestinal tract.

H. Lozenges Or Troches
These are disc-shaped solid preparations containing medicinal agents and generally a
flavouring substance in a hard candy or sugar base. They are intended to be slowly dissolved
in the oral cavity, usually for local effects.

Examples include Strepsils Dry Cough Lozenges – Dextromethorphan Hydrobromide 5mg,

Dichlorobenzyl alcohol 1.2mg, Amylmetacresol 0.6mg (Reckitt Benckiser), Dequadine –
Dequalinium chloride BP 250mcg (Evans Medical PLC), Dr Meyer Coflin cough lozenges
(Meyer Organics PVT Ltd), Cofta – Ammonium chloride/ Ipecacuanha tablet (Evans Medical
PLC) etc
I. Tablet Triturates
Tablet triturates are small, usually cylindrical, moulded, or compressed tablets containing
small amounts of usually potent drugs mixed with a combination of sucrose and lactose or
any suitable diluent. They are prepared from moist material, using a triturate mould that gives
them the shape of cut sections of a cylinder.

Since tablet triturates must completely and rapidly dissolve in water, only a minimal amount
of pressure is applied during their manufacture. One of the problems encountered during the
manufacture of this tablet type is the failure to find a lubricant that is completely water-
soluble. A typical example of tablet triturate is NTG tablets.

J. Hypodermic Tablets
Hypodermic tablets are soft, readily soluble tablets that were originally used by physicians in
extemporaneous preparation of parenteral solutions. These tablets are dissolved in a suitable
vehicle (water for injections) and administered by parenteral route.

Hypodermic tablets are no longer used in most countries due to the difficulty in achieving
sterility. Also, the availability of stable parenteral solutions and prefabricated injectable
products, some in disposable syringes have also discouraged their use in recent times. e.g.,
Dilaudid – Dihydromorphinone HCl (Bilhuber Knoll Corp.).

K. Dispensing Tablets
Dispensing tablets also referred to as compounding tablets are tablets supplied primarily as a
convenience for extemporaneous compounding. These tablets contain large amounts of
highly potent APIs, and thus are used by a pharmacist to compound prescriptions that can be
incorporated readily into powders and liquids, thus, circumventing the necessity to weigh
small quantities of these potent drug substances.

Dispensing tablets are no longer in use and had the dangerous potential of being inadvertently
dispensed as such to patients. Examples include silver potentiate, bichloride of mercury
merbromin and quaternary ammonium compounds.

L. Gelatin-Coated Tablets
Gelatin-coated tablets are compressed tablets coated with either one or two-toned colour
gelatin. The gelatin coating impacts the same general characteristics as sugar coating and film
coating with the added advantage of improving the stability of photosensitive APIs.
The gelatin coating also facilitates swallowing, enables custom branding, and prevents
counterfeit since they are more tamper-evident than unsealed capsules. Gelatin-coated tablets
are also ideal for double-blind clinical studies, or for drug substances that can irritate the
oesophagal mucosa when they are incorporated in an immediate-release tablet such as
bisphosphonates.

Example of gelatin-coated tablets includes gelatin-coated hydrochlorothiazide tablet

(Qualitest Pharmaceuticals), Tylenol Cold Multi-Symptom Daytime (McNeil Consumer) etc

M. Multiple Compressed Tablets/ Multi-Compressed Tablets

Multiple compressed tablets, also called multi-compressed tablets are tablets that are
composed of two or more layers. These tablets are prepared by subjecting the fill material to
more than one compression cycle.

The result may be a multiple-layer tablet or a tablet within a tablet, the inner tablet being the
core and the outer portion being the shell. This process is best used when separation of active
ingredients is needed for stability purposes or if the mixing process is inadequate to guarantee
uniform distribution of two or more active pharmaceutical ingredients.

Multiple compressed tablets can also be used when there is a need to mask the bitter taste of a
drug substance or where the drug substance in question is irritant to the stomach. There are
three subclasses of multiple compressed tablets and they include compression coated tablets,
layered tablets and inlay tablets.

i. Compression Coated Tablets

Compression coated tablets also referred to as dry-coated tablets or press-coated tablets, are
tablets with two parts; internal core and surrounding coat. These tablets are prepared by
feeding previously compressed tablets into a special tablet press.

(e.g., Manesty Drycota) and compressing another granulation layer around a preformed
tablet core.
 Compression coated tablets have all the advantages of compressed tablets (i.e., slotting,
monogramming, speed of disintegration) while retaining the attributes of sugarcoated tablets
in masking the taste of the drug substance in the core tablets.These tablets can also be used to
separate incompatible drug substances (one in the core and the other in the coat); in addition,
they can provide a means of giving an enteric coating to the core tablets.

ii. Layered Tablets

They are tablets composed of two or more layers of ingredients. Layered tablets are prepared
by compressing additional tablet granulation on a previously compressed granulation to form
two-layered or three-layered tablets, depending on the number of separate fills. Each layer
may contain a different medicinal agent, separated for reasons of physical or chemical
incompatibility, staged drug release, or simply the unique appearance of the layered tablet.

Unlike conventional tablets where we have a single piece of substance moulded to shape,
layered tablets have the appearance of a sandwich because the edges of each layer are
exposed.
iii. Inlay Tablets
Inlay tablets, popularly known as dot, or bull’s-eye tablets are variation of compressed tablets
with a partially surrounded core. Instead of the tablet core being completely surrounded by
the coating, its top surface is completely exposed.

Inlay tablets are prepared by feeding previously compressed tablets into a prefilled die cavity
of Stokes, Colton, or Kilian machines. When compressed, some of the coating material is
displaced to form the sides. With a yellow core and a white coating, Inlay tablets resemble a
fried egg.

Inlay tablets can be useful in sustained-release preparations to reduce the size and weight of
the tablet. A typical example is a European preparation containing 25 mg of
hydrochlorothiazide in the bull’s-eye and 600 mg of potassium chloride in the outside
portion.

N. Immediate-Release Tablets
Immediate-release tablets are tablets designed to disintegrate and release their medication
with no special rate-controlling features, such as special coatings and other techniques. This
is the most common type of tablet and examples include, chewable, effervescent, sublingual
and buccal tablets.

O. Rapid-Release Tablets
Rapid-release tablets, also called rapidly dissolving tablets, rapidly disintegrating tablets,
orally-dispersible tablets, quick disintegrating tablets, mouth dissolving tablets, fast
disintegrating tablets, fast-dissolving tablets, rapid-dissolving tablets, or porous tablets are
characterized by disintegrating or dissolving in the mouth within 1 minute, some within 10
seconds, leaving an easy-to-swallow residue.

Tablets of this type are prepared using very water-soluble excipients designed to wick water
into the tablet for rapid disintegration or dissolution without chewing.
 Rapid-release tablets offer increased convenience and ease of administration with the
potential to improve compliance, especially when swallowing conventional solid oral-dosage
forms presents difficulties for the patient.

Notwithstanding these advantages, there are a number of disadvantages and difficulties

associated with formulating rapid-release tablets, including drug loading, taste masking,
friability, manufacturing costs, and stability of the product.

Examples of rapid-release tablets include Clarinex Reditabs [desloratadine], Schering.

P. Extended-Release Tablets
Extended-release tablets sometimes called controlled-release tablets, prolonged-release,
delayed release or sustained release tablets are tablets designed to release their medication in
a predetermined manner over a prolonged period of time. These tablet types are categorized
into

 Those that respond to some physiological condition to release the drug, such as enteric
coatings;
 Those that release the drug in a relatively steady, controlled manner; and
 Those that combine combinations of mechanisms to release pulses of drug such as repeat
action tablets.
A typical example of this tablet type is Divalproex-Sodium-Extended-Release-Tablets.

Q. Vaginal Tablets/ Vaginal Inserts

Vaginal tablets are uncoated, bullet-shaped, or ovoid tablets designed for vaginal
administration. They are prepared by compression and are shaped to fit tightly on plastic
inserter devices that accompany the product.
 Following insertion, retention and slow dissolution of the tablet occur, releasing the
medicaments to provide the local pharmacological effect (e.g. for the treatment of bacterial or
fungal infection).

Vaginal tablets may also be used to provide systemic absorption of therapeutic agents.
Examples include Gyno-Tiocosid (Neimeth), Gynesatum- Clotrimazole vaginal Tablet
(Chazmax Pharmaceutical Industries Limited), Nystamark-Nystatin Vaginal Tablet (Mark
Pharmaceuticals) etc.

R. Implantation Tablets/ Implants

These are long-acting sterile tablets designed to provide continuous release of drugs, often
over a period of months or a year. They are placed subcutaneously for systemic or local
delivery.

Implants are mainly used for the administration of hormones such as testosterone steroids for
contraception. They usually contain rate-controlling excipients in addition to the active
ingredient(s).

Several types of implants are available including pellets, resorbable microparticles, polymer
implants, in situ–forming gel/solid implants, metal/plastic implants, and drug-eluting stents.

Examples of implantation tablets include Implanon – etonogestrel (Organon), Disulfiram

Tablet for Implantation etc.

Tablet Excipients/ Ingredients

In tablet formulation, many materials are usually combined at various quantities to produce a
tablet that is of good standard. These materials serve different and specialized functions in the
tablet. The type and quantity of each raw material used is dependent on the intended tablet
type and formulation technique. Tablet Excipients include:

 Binders /granulating fluid –e.g., include acacia gum, tragacanth, corn starch, methylcellulose,
gelatin, panwar gum, ghatti gum, mucilage of isapol husks, carboxymethylcellulose,
 methylcellulose, polyvinylpyrrolidone and sugars, such as sucrose, glucose, dextrose,
molasses, and lactose etc.
 Bulking agents/ diluents/fillers – g., anhydrous lactose, spray dry lactose, microcrystalline
cellulose, corn starch, dicalcium phosphate, calcium sulfate, lactose, cellulose, kaolin,
mannitol, sodium chloride, etc.
 Disintegrating agents – e.g., starch, clays, celluloses, algins, gums, and cross-linked polymers
(croscarmellose, crospovidone, and sodium starch glycolate) etc.
 Lubricants – g., metallic stearate (0.1-0.2 % w/w) e.g., magnesium stearate, calcium stearate,
stearic acid (0.25-1 %), hydrogenated vegetable oil, corn starch, boric acids, sodium chloride,
sodium lauryl sulphate etc.
 Glidants – e.g., colloidal silicon dioxide Cab-o-sil (Cabot), Talc (asbestos-free) etc.
 Colouring agents/ Colourants – e.g., FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No.
3,

 Flavoring agents/ Flavorants – e.g., Aspartame (Pfzer)

 Adsorbent – e.g., silicon dioxide, magnesium oxide, starch, magnesium silicate etc.

TABLETS MANUFACTURED METHODS:-

Tablets are commonly manufactured by one of the following manufacturing processes:

1.WET GRANULATION METHOD:-

1. Milling of drugs and excipients.

2. Mixing of drugs and excipients (excluding the lubricant).
3. Preparation of binder dispersion.
4. Mixing of binder solution with powder to form a coarse mass.
5. Coarse sieving
6. Drying of moist granules.
7. Sieving of the dried granules and mixing with disintegrant and lubricant.
8. Compression into tablets.
Manufacture of tablets by wet granulation method
Wet granulation method is a process of size enlargement in which fine powder particles are
agglomerated or brought together into larger, strong and relatively permanent structure called
granules using a suitable non-toxic granulating fluid such as water, isopropanol or ethanol (or
mixtures thereof). The granulating fluid can be used alone or as a solvent containing binder or
granulating agent. The choice of the granulating fluid depends greatly on the properties of the
materials to be granulated. Powder mixing, in conjunction with the cohesive properties of the
granulating agent, enables the formation of granules. The characteristics and performance of
the final product, greatly depends on the extent to which the powder particles interact with
each other to form aggregates (granules)
 2.DRY GRANULATION (SLUGGING OR ROLLER COMPACTION/
CHILSONISATION) METHOD:-
1. Milling of drugs and excipients.
2. Mixing of milled powders.
3. Compression of mixed powders into slugs (big tablets).
4. Milling and sieving of the slugs.
5. Mixing with disintegrant and lubricant.
6. Compression into tablets
DRY GRANULATION METHOD:-
Formation of granules using dry granulation process is generally achieved either by slugging
technique or roller compaction. The two techniques are similar but they can give different
results

Slugging Technique:-
This process involves compression of primary powder particles into large flat tablets or
pallets using a tablet press or, more usually, a large heavy-duty rotary press. The resultant
compact is then milled using a hammer mill or other conventional milling equipment. The
milled slugs are passed through a screen of desired mesh for sizing. Lubricant is added in the
usual manner, and the granules compressed into tablets.
Slugging results in considerable dust production which poses a problem for good containment
and reduction of cross-contamination. Other main shortcomings of slugging include batch
processing, low throughput (30–50 kg/hr), poor process control, frequent maintenance
changeovers and poor economy of scale. The method is being replaced by the more modern,
and better, roller compaction process.
 Roller Compaction:-
Roller compaction (also referred to as ribbon blending) is a relatively simple, more efficient
and inexpensive form of dry granulation. It is a process where formulation ingredients are
continuously passed between two counter-rotating rollers where it is densified and
consolidated into a sheet of solid mass. Depending on the type of rollers used, the feed
material may be compacted into dense ribbon-like materials known as flakes (smooth rolls)
or dense briquettes (almond or stick-shaped) if the rollers have grooved or etched surfaces.
The compacted materials are further milled, sized, lubricated and compressed into tablets.

Roller compaction offers distinct advantages over wet granulation, particularly for moisture-,
solvent-, or heat sensitive formulation ingredients. In the pharmaceutical industry, it is an
attractive granulation alternative as it offers considerable cost savings due of its high
production throughput (up to 100,000 kg/hr), shorter cycle times and fewer processing steps.
Moreover, elimination of a drying step reduces production and development time as well as
ease of scale-up.

Excipients used in manufacture of tablets by dry granulation method

The types of excipients used in the manufacture of tablets by dry granulation method and the
rationale for their use are similar to those described in the article “Excipients Used in the
Manufacture ofPharmaceutical Tablets”. Typically, the following excipients are required:
 Diluent/filler, e.g., Microcrystalline cellulose (MCC), anhydrous lactose or lactose
monohydrate, dibasic calcium phosphate, starch etc.
 Disintegrants, e.g., croscarmellose sodium, sodium starch glycolate, pregelatinized starch
1500, crospovidone, starch, MCC, etc.
 Lubricants, e.g., stearates (magnesium stearate, stearic acid), glyceryl fatty acid esters
(glyceryl behenate, glyceryl palmitostearate), Polyethylene glycol (PEG), polyoxyethylene
stearates, sodium lauryl sulphate.
 Glidants, e.g.: talc, colloidal silicon dioxide.
 Miscellaneous excipients such as colourants, flavourant, sweetening agents, etc.
 DIRECT COMPRESSION METHOD:-
1. Milling of drugs and excipients.
2. Mixing of powders, disintegrant and lubricant.
3. Compression into tablet

Techniques in direct compression

The processes involved in the manufacture of tablets by direct compression method can be
summarized in three steps.

1. Direct compression technique using induced die feeders

2. Direct compression technique using dry binders and
3. Direct compression technique using direct compression excipients
1. Direct Technique Using Induced Die Feeders Compression :-
This involves the use of a special feeding device which prevents segregation and enhances
the flow of powders from the hopper into the die cavity of a tablet press. The use of induced
die feeder also reduces air entrapment, making the fill powder more dense and amenable to
compaction. Direct compression technique using induced die feeder is used when formulation
ingredients will compact but will not adequately fill the die cavity.

2. Direct Compression Technique Using Dry Binders:-

This technique will affect compression of drugs at relatively low filler to drug ratio, with little
addition of preparatory techniques. Materials used as dry binders should possess adequate
cohesive or compressibility properties in order to form satisfactory tablets of acceptable
hardness and friability. They should possess adequate flowability and bulk density to ensure
the die cavities are uniformly filled and hence tablets of uniform weight and drug content
would be obtained. They should also have high capacity or low binder to drug ratio in order
to make possible the manufacture of suitable sized tablets containing relatively high doses of
drugs.

Examples of dry binders used in the manufacture of tablet by direct compression method
include microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000 etc.

3. Direct Compression Technique Using Direct Compression Excipients:-

A direct compression excipient also referred to as direct compressible excipient or direct
compression filler/binders are inert, non-medicinal substances which may be compacted with
no difficulty and which may do so even when mixed with drug substances. Direct
compressible excipients should exhibit satisfactory tabletting characteristics. This is because
they determine the overall characteristics of the tablet, particularly in regard to the fluidity of
the component powders. Direct compressible excipients can also influence the hardness,
disintegration and dissolution characteristics of the finished tablets.
COMMON TABLET DEFECTS THAT CAN BE AVOIDED EASILY:-
Tablet defects occur for a variety of reasons, but many can easily be avoided. To address
defects, technicians involved in tabletting must have a full understanding of both the
tabletting process and the materials used. Adequate training in the setting up and use of the
machines is vital if the technician is to have the necessary skills to be able to fix equipment
and minimize problems in production. A professional and experienced technician can turn an
ordinary product into a high quality one whereas a novice or inexperienced operator cannot,
and might even be afraid to adjust the machine in order to prevent or correct problems. When
the equipment is properly operated the tablet production will go smoothly.

Problems such as tablet defects can cause the company loss of production time and sales, and
therefore money. Common problems that afflict the tabletting industry include:

 Weight variation
 Friability
 Hardness
 Sticking
 Picking
 Capping
 Laminating
 Chipping
 Mottling
 Double press or impression

CAPPING:-
Capping happens when a fracture occurs at the top of the tablet and the top, or cap, separates
itself from the body of the solid tablet. It is often caused by air trapped in the powder material
during the compression stage. It can also arise because the press fails to compress the
formulation due to the collection of powder fines.

When a tablet is compressed air is expelled from the powder granules allowing each of the
particles to stick together. The press is designed to allow the air to dissipate during the
compression process. As the air is released from the granules it can also push very fine dry
granules fines outwards. These particles generally do not stick together and when the
particles are pushed into the line of air being released near the cup and the tablet band, the
fines prevent the granules from being compressed resulting in the tablet becoming fractured.

As the air is released when the upper punch die tip is raised, capping only occurs at the top of
the tablet. If a fracture occurs in the lower part of the tablet, it is referred to as lamination, and
is discussed below.

The faster the press speed, the more likely it is that capping will occur and simply reducing
the speed of the press will often solve the problem. That said, there are other ways that this
problem may be solved.

Poor formulation as well as bad processing practice can often cause capping. Dry blends can
cause capping, as a low moisture content of the formulation tends to prevent the particles
from blending with each another. The binder, which is added to a formulation to help bind the
particles together, may not be adequate for the particular materials. In the event that capping
does occur, it is therefore worthwhile reviewing the choice of binder. Improper mixing or
blending can add air to the formulation, and inadequate mixing can also cause powders to
segregate, leading to tablet capping. Over blending can itself cause problems so careful
optimization of the blending process is required to ensure consistent quality of tablet
production.

Capping is usually easy to fix either by increasing the dwell time (i.e., slowing down the
production) or by careful analysis of the formulation and production process.

LAMINATION:-
Lamination is the term used for a split in the tablet anywhere but at the top. Lamination is
essentially the same as capping and with similar causes. It is, nevertheless, important to
diagnose the lamination issue correctly to ensure that proper steps are taken to solve the
problem. Lamination often occurs due to the over compression of the tablet. Too much
compression can lead to the granules flattening out and thus preventing them from locking
together. This can also happen when light or fine particles do not combine, as these particles
do not compress well. To prevent this, the thickness of the tablet needs to be reduced, and/or
the dwell time increased to allow the fine particles to combine. To increase dwell time, pre-
compression can be employed or the speed of the tablet machine can be reduced. Another
option is to use a tapered die rather than a perfectly cylindrical die bore. Tapered dies
generally do not exhibit capping or laminating problems.

STEPS IN ELIMINATING CAPPING/LAMINATING;-

1.Punch Penetration:-. Check if the tablet press has an adjustable punch penetration.
Adjusting the upper punch penetration depth in the die can allow better air exhaust, which
can often solve the issue quickly. The punch penetration setting for pre-compression
penetration does not have to be the same as for the main compression step.
2.Pre-Compression:- New models of high-speed rotary tablet press incorporate pre
compression, which is an initial compression step before the main compaction step. Pre-
compression is a means of compact the powder but at a lighter pressure than the main
compression step. It is used especially if there are dry dust fines or particles – it binds the
particles together using a lighter force, so that they cannot migrate out during the final
compression step. If the tablet needs more dwelling time, pre-compression can be done twice
with a higher force the second pre-compression step.

3.Slow The Press Down:- By decreasing the speed of the press, the dwell time or the time
that the tablet is under pressure is increased. By slowing the press and extending the dwell
time, air is allowed to evacuate, giving the particles time to bind themselves to each other,
leading to a controlled hardness once tablets are released. It is important, however, to make
sure that the dwell time is not too long as that may lead to particles becoming too dry and the
tablets laminating. Clearly extending dwell time is one method of solving the capping issue
but it needs to be managed so that it does not introduce a laminating issue.

4.Tooling Design:- The design of the tablet tooling can influence capping and laminating. A
dome headed tool can extend dwelling time and changing the cup depth and radius can help
make air release faster during compression stage. Additionally, adding a taper to the die can
help evacuate trapped air during compression and reduce the tendency of the tablet to cap.
Tapering can also reduce the force that contributes to the tablets’ tendency to laminate.
Remember that proper care and maintenance can eliminate other problems such as j-hook,
compression wear rings within the die and premature punch tip wear.

STICKING AND PICKING:-

The sticking defect occurs when the granules of a formulation become stuck to the face of the
press punch. Picking, on the other hand, happens when the granules stick to the design
embedded in the punch tip such as in lettering or logos. Both sticking and picking result in
defective tablets. A visual inspection is usually carried out as an element of quality control,
and may identify sticking and picking. Visual inspection, however, is time-consuming and
can decrease the yield production – but many manufacturers have no option. As the batch
reaches the compression stage, the operator must adjust the press to comply with the
product’s characteristic designs. The tablet press setup and operation, tooling and
maintenance can each affect the quality of the product. There are also times when the
granules not fully dried. That is, they may be dry and hard on the outside but moist or wet on
the inside. This can seriously affect the quality of the tablet as the poorly dried particles can
break open during compression and stick to the surfaces of the punch press. If this happens, it
is important to check the granule drying process.

STEPS TO IMPROVE AND ELIMINATE STICKING:

1.Adjusting The Compression Force:- The compression force can affect the product in that
increasing the force may cause sticking for over-granulated products and decreasing force
may result in the particles sticking to the punch face than to each other.

2.Increase Pressure:- If picking is observed, one the punch pressure can be increased to
encourage the particles to bond with each other rather than stick to the punch.

3.Pre-Compression:- Use of extended dwelling time through pre-compression or slowing

the press speed makes the granules stick together rather than on the punch face.
 4.Polishing:-Polishing the punch face may help with the sticking problem.

5.Proper Lubricant Mix:-It is important to mix the lubricant properly as over mixing can
result to the lubricant being ineffective in preventing sticking or picking.

Sticking can happen anytime during production, but most often happens during the initial
setup of the press. Although sometimes unpredictable, it can also be a frequent occurrence,
and what may be an acceptable level of sticking for one product may not be for another. To
determine the likelihood of sticking, it pays to know the product and formulation properties
such as the moisture content and size distribution of the particles. Having said that, it is only
when the formulation is in the tablet press that sticking will become apparent..

TABLET HARDNESS:-
Another problem with tablet production is variation in the hardness of the tablet. A soft tablet
can cause a multitude of problems not only with the press but also with product consistency,
film coating process and packaging which can sometimes lead to product recall.

The first step in addressing issues of tablet hardness is to check the press before investigating
the upstream processes

1.Weight Control:- Maintaining the weight of the tablet is the key to controlling its
hardness; fluctuations in the weight cause changes in the hardness of the tablet. Accuracy in
the control of tablet weight with respect to a target weight is therefore especially important. A
tablet that is lighter than the target tends to be soft tablet whereas a heavier tablet tends to be
harder. If there are variations in the bulk density, then the die filling will not be consistent,
resulting in wide variations in tablet weight.

2.Scraper Blade And Die Fill:- The scraper blade is often overlooked as a item that wears,
and should be replaced regularly. If the product is very abrasive it may be that the scraper
blade should be changed on a daily basis. For other regular products, the blade may last for
several months. Blade lifetime is therefore dependent on the product type and how well the
blade is maintained.

COATING:-

DEFINITION:- A tablet coating is a covering over a tablet, used to mask the taste, make it
easier to swallow, or protect the active medication inside. A tablet coating is applied to make
the tablet smoother and easier to swallow. A tablet coating colors and protects the tablet, and
masks a bad taste.

Types Of Tablet Coating:-

 Sugar Coated Tablets (SCT) Have you ever take medicine that taste sweet? ...
 Film Coated Tablet (FCT) This type of coating is the most widely used. ...
 Enteric Coated Tablet (ECT) ...
 Compression Coating. ...
 Gelatin coated tablet.
 1.Sugar Coating:-
Sugar coating has long been the traditional method of coating pharmaceutical dosage forms.
The process has its origin in the confectionery industry and has been used in the
pharmaceutical industry since the late 19th century. The process of sugar coating involves the
successive deposition of aqueous sugar solution on the tablet cores as they are rotated and
tumbled in a revolving pan by spraying sugar solution or suspensions into pans and drying off
the solvent.
Steps Involved In Sugar Coating:-
Sugar-coating process consists of various steps, each designed to achieve a particular
function. A typical sugar-coating process encompasses six stages:

1. Sealing of the tablet core

2. Subcoating
3. Smoothing
4. Colour coating`
5. Polishing
6. Printing

1. Sealing Of The Tablet Core (Waterproofing/ Protective Coating):-

Seal coating involves the application of specialized polymer-based coating (either by ladle or
spray techniques) directly to the tablet core. It is an optional step but is usually required to prevent
the tablet core and its contents from absorbing water, softening, and initiating disintegration
during the subsequent steps of the sugar-coating process. Sealing also prevents certain types of
materials (e.g. oils, acids, etc.) from migrating to the tablet surface and spoiling the appearance.

In a manual seal-coating operation, the sealant which usually consist of alcoholic solutions of
resins (approximately 10–30% solids) is evenly and gently poured or sprayed over the tumbling
tablet bed (preheated to 40oC). Warm air is then blown into the pan during the coating to hasten
the drying and to prevent tablets from sticking together.
.

Because most sealing coats develop a degree of tack (stickiness) at some time during the drying
process, detackifiers, such as asbestos-free talc, are often used to minimize the risk of “twinning”
or clumping.

Common materials used as sealants include shellac, zein, hydroxypropyl methylcellulose

(HPMC), cellulose acetate phthalate (CAP), or polyvinyl acetate phthalate (PVAP). While use of
 shellac has been universal, this natural polymer can undergo further polymerization on storage,
causing the seal coat to become completely insoluble to the point where bioavailability of the
active drug substance may be compromised.

2. Subcoating
This step is regarded as the first major step in sugar-coating process. It involves the application of
large quantities of sugar-coatings to the tablet core, significantly increasing the tablet weight by
50 – 100 %. Subcoating provides the rapid buildup necessary to round up the tablet edge. It also
provides the foundation for smoothing and colour coating with any weakness in the final sugar
coat often being attributable to weaknesses in the subcoat.

I. Lamination Process:-
The lamination process is perhaps the older of the two techniques used, and involves application of a
“glue” (in the form of an aqueous solution of a suitable gum, such as gum acacia, or even gelatin) in
quite substantial quantities to the sealed tablet cores. Once this solution has been distributed uniformly
throughout the tablet mass, it is followed by a liberal dusting of powder (which serves to reduce tack
and facilitate tablet buildup) and drying. This process of application of gum solution, spreading,
dusting, and drying is repeated until a satisfactory coating is achieved.

II. Suspension Subcoating Process:-

This is an alternative approach used particularly when using an automated dosing system. The
process involves the application of a suspension subcoat formulation (essentially a coating
formulation where the powdered materials used in the more traditional lamination process are
dispersed into the gum-based solution). Employing suspension subcoating approach not only
reduces the complexity of the process, but also enables the less-experienced operator to achieve
satisfactory results.

3. Smoothing or Grossing:-
In order to manufacture quality sugar-coated tablets, it may be necessary to smooth out the
tablet surface and fill the irregularities generated during subcoating. Smoothing usually can
be accomplished by applying sucrose-based solution with or without additional components
such as starch and calcium carbonate. This is followed by drying until the tablets are properly
rounded and smooth. Drying may last up to 20 minutes or more depending on the scale of
operation. In some operations, 5 to 25 applications may be required to achieve smooth tablets
that are suitable for the next stage.

4. Colour coating/ Colouring:-

This is one of the most important steps in the sugar-coating process as it has immediate visual
impact that is associated with overall quality. It involves the multiple application of syrup
solutions (60–70% sugar solids) containing the requisite colouring materials necessary to
 achieve the desired shade. As with film coating colours, sugar-coating colourants may be
subdivided into either water-soluble dyes

5. Polishing/ Glossing:-
Sugar-coated tablets are, by nature very dull in appearance (i.e., they have a matte surface
finish), and thus requires a separate polishing step to give them the high degree of gloss that
typifies finished sugar-coated tablets. Polishing is accomplished by applying mixtures of
waxes either as powders (usually in a finely milled form) or as solutions/dispersions in
various organic solvents to the coated tablets in a polishing pan.

Some polishing systems which are currently in use include:

 Organic-solvent-based solutions of waxes (beeswax, carnauba wax, candelilla wax, hard

paraffin wax)
 Alcoholic slurries of waxes
 Finely powdered mixtures of dry waxes
 Pharmaceutical glazes (typically alcohol solutions of various forms of shellac, often
containing additional waxes).
 Mineral oil.
6. Printing:-
It is common practice to identify all oral solid dosage forms with a product name, company
name or logo, dosage strength or other distinctive symbol. For sugar-coated tablets, such
identification involves the application of special edible inks to the coated tablet surface by
means of a printing process known as offset rotogravure.

Printing prior to polishing enables the ink to adhere more strongly to the tablet surface, but
any legend may subsequently be removed by either friction or as a result of contact with
organic solvents during the polishing process. Printing after polishing avoids the problem of
print rub-off during polishing, but branding inks do not always adhere well to the waxed
tablet surface. Adhesion of printing inks can be enhanced by application of a modified
shellac, preprint base solution prior to printing.

FILM COATING:-
- A film coating is a thin polymer-based coat applied to a solid dosage form such as a tablet.
The thickness of such a coating is usually between 20-100 µm. It is possible to follow the
dynamic curing effect on tabletcoating structure by using non-destructive analytical
methodologies.

Raw Materials Used In Film Coating Formulations

A Typical Film-Coating Formulation Contains The Following Materials:-

1. Polymer
2. Plasticizer
3. Colourants
4. Solvent/ Vehicle
 Polymers:-
Polymers are substances whose molecules have high molar masses and are composed of
many repeated subunits. They are formed by chemical reactions in which a large number of
molecules called monomers are joined sequentially, forming a chain.

In the majority of film-coating formulations, the polymer is the major component in the
coating solution. Consequently, this material will have the greatest impact on the final
properties of the coating. Some of the key attributes that the film-coating polymer must
possess include:

i. Solubility in a wide range of solvent systems

ii. Solubility requirement for the intended use e.g. free water-solubility, slow water solubility or
pH-dependent solubility
iii. Stability against light, oxygen, moisture, heat and the substrate being coated
iv. Continuous film formation capability with adequate mechanical properties
v. High compatibility with other film-coating additives and the tablet being coated
vi. Low viscosity at the preferred concentration (for adequate atomization)
vii. Nontoxic with no pharmacological activity
viii. Capacity to produce an elegant looking product even in the presence of additives
Polymers used in film coating fall into the following categories.

1. Cellulose ethers e.g., Hydroxy Propyl Methyl Cellulose (HPMC), Hydroxy Propyl Cellulose
(HPC), Ethyl Cellulose (EC), Methyl Cellulose
2. Vinyl polymers e.g., polyvinyl pyrrolidone
3. Glycols e.g., high molecular weight polyethylene glycol
4. Acrylic acid polymers e.g., Eudragits

Plasticizers:-
Plasticizers are relatively low molecular weight materials which are added to film-coating
formulations to modify the physical properties of polymers. This is necessary because most
acceptable film-coating polymers are essentially amorphous, and as such, exhibit a
reasonably well-defined glass transition temperature, Tg (a fundamental characteristic of
polymers that has a profound effect on polymer properties that can also influence film
formation, especially when using aqueous polymer dispersions).

Examples of plasticizers commonly used in film coating processes include:

a. Polyols, such as glycerol (glycerin), polyethylene glycols (PEG 200 – 6000 grades) and
propylene glycol.
b. Organic esters, such as Diethyl phthalate (DEP), Dibutyl phthalate (DBP), Dibutyl sebacate
(DBS), Triethyl citrate (TEC), Acetyltriethyl citrate (ATEC), Acetyltributyl citrate (ATBC),
Tributyl citrate (TBC), and Triacetin (glyceryl triacetate; TA).
c. Oils/ glycerides, such as fractionated coconut oil, castor oil, and distilled acetylated
monoglycerides (AMG).
 Colourants:-
Colourants are included in many film-coating formulations to:

a. Improve product appearance and enable product identification

b. Modify the gas permeability of a film
c. Decrease the risk of counterfeiting the product
d. Protect the active ingredient against light by optimizing the opacifying properties of
pigments.

Solvents/ Vehicles:-
Solvents are used to dissolve or disperse coating materials and convey them to the surface of
the tablet core. Initially, film-coating processes were very much dependent on the use of
organic solvents in order to achieve the rapid drying characteristics demanded by the process.
Unfortunately, concerns with operator’s safety, environmental, and cost-related issues have
provided the momentum for the current utilization of aqueous-based film coating as the
preferred option. However, the use of solvents has continued, especially when:

i. The coating process will not accommodate the use of water (i.e., drying is poor);
ii. The adhesion achieved with aqueous systems is unacceptable;
iii. Certain critical ingredients (e.g., polymer) are neither water-soluble nor available as a latex
system; and
iv. Exposure to an aqueous process would cause stability problems for the product being coated.

Miscellaneous coating solution component

While polymers, plasticizers, colourants, and solvents constitute the major ingredients in
film-coating formulations, other materials might be used occasionally in low concentrations
for specific formulations.

Flavours and sweeteners may be added to mask unpleasant odour of some drugs or to make
them more palatable.

Surfactants or dissolution enhancers such as polyoxyethylene sorbitan derivatives may be

added to

i. Emulsify water-insoluble plasticizers

ii. Improve substrate wettability and enhance spreadability of the film during application
iii. Stabilize suspensions
Additionally, some film coatings may also contain preservative/ antimicrobials (e.g.,
carbamates, alkylisothiazloinone, benzothiazoles etc.), adhesion enhancers (such as
polydextrose, maltodextrin, and lactose), antifoaming agents (e.g., dimethylpolysiloxane),
antioxidants (e.g., oximes, phenols etc.), pore – forming agents (e.g., sucrose or sodium
chloride with ethylcellulose-coated salicylic acid tablets) and waxes. In rare instances, the
film coat itself may contain active drug substance.
 3.ENTIRE COATING:- Enteric coating. An enteric coating is a polymer barrier applied
on oral medication that prevents its dissolution or disintegration in the gastric environment.
... Tablets, mini-tablets, pellets and granules (usually filled into capsule shells) are the most
common enteric-coateddosage forms.
Classification And Types Of Tablet Coating Equipment:-
There are several types of tablet coating machines currently in the market. Depending on the
working principles, these machines may be classified into:

a. Standard Coating Pan/ conventional pan system

i. Pear-shaped
ii. Hexagonal
iii. Spherical
b. Perforated Coating Pan
i. Accela-Cota/Hi-coater Systems
ii. Driacoater
iii. Glatt coater
c. Fluidized Bed Coater
1. Hardness/ crushing strength test
2. Friability test
3. Stability studies
4. Water vapour stabilities
5. Adhesion test
6. In vivo drug release in different experimental animals
Standard Coating Pan:-
Standard coating pan, which is also known as the conventional pan system is a popular
accessory in most pharmaceutical industries.

Basically, the design of this type of tablet coating machine is such that there is a circular
metal pan whose diameter may range from 6 to 80 inches (15 to 200 cm). The pan is slightly
tilted to an angle of about 45°C to the bench top.
 Fig:-SaintyCo sugar coating machine

The standard coating pan has an electric motor that rotates the circular metal pan horizontally
to its axis.

It is the motion of this pan that causes a batch of tablets to tumble.

Again the conventional pan system has an inlet air supply.

This inlet port supplies heated air.

A) Immersion Tube System:-

Here, the tablet coating machine manufacturer includes a tube that you will immerse in the
tablet bed.

This tube has a spray nozzle that delivers both the hot air and coating solution.
 Fig:-An Immersion Tube System For Tablet Coating Machine

As you can see, the immersion tube system delivers heated air and coating solution
simultaneously.

It is basically a long tube with a spray nozzle at its tip.

The design is such that the drying air (heated air) flows upwards and leaves the system by
conventional duct.

By incorporating an immersion tube system in standard coating pan, you will increase the
drying efficiency.

It is a technique that is handy for both sugar coating and film coating machines.

Apart from this, you can opt for:

B) Baffled Pan And Diffuser:-

A baffled pan and diffuser, which is also called the pellegrini, also improves the drying
efficiency of standard coating pan. In this process, the tablet coater can distribute drying air
uniformly on the coated tablets.
 Fig:- A summary of types of standard coating pan

However, the standard coating pan with baffled pan and diffuser are only suitable for a sugar
coating process.

This is due to the limited drying capability.

Again, in case the two are not available, you can try:

C) Immersion Sword System:-

This is basically a perforated metal sword that you can immerse in the tablet bed.

The working principle is such that:

During the drying process, you will introduce drying air which flows through perforated
metal sword then upwards through the bed.
This is an immersion sword system for a tablet coating equipment

This way, you can improve the drying efficiency in standard coating pan systems.

Clearly, you can see we have 3 different types of standard coating pan machines.

The variation is mainly due to the process of drying the coated tablets.

Apart from the conventional coating system, another type of tablet coating machine is the:

Perforated Coating Pan:-

Perforated coating pan is also popular among many pharmaceutical companies.

In most cases, this type of tablet coating equipment has either a full or partial perforated
drum.

Like the standard coating pan, the drum of this tablet coater rotates on a horizontal axis.

A) Accela-Cota System:-
First, I want you to review the image below. It illustrates important aspects of an accela-cota
tablet coating machine.
 Fig:-An illustration of drying air movement and coating solution

As you can see, there are a number of processes that take place within the drum.

 Baffles ensure the tablets mix freely within the drum as it rotates
 Spray gun atomizes the coating solution and directs it to the tablets
 Dry inlet air flows from the upper section of the drum, passing in between the tablets.
It leaves the drum through the perforations.

This increases the overall efficiency of this type of tablet coating machine.

B) Dria Coater Pan:-

When you look at the figure below, the difference between accela-cota system and dria coater
pan is quite clear.

fig: dria-coater tablet coating machine

A dria coater pan has hollow perforated ribs, which are locate on the inside periphery tablet
coating drum.

Therefore, as the drum rotates, the spray nozzle atomizes coating solution and directs it to the
tablets from the top section.

However, the drying air enters the coating drum from below the tablets and flows upwards,
then exits the system through the back of tablet coating pan.

Remember, this is not the case in the accela-cota.

Basically, in dria coater, the drying air fluidizes the tablets. You can see the tablets suspended
in air.

C) Hi-Coater System:-
Although the design of hi-coater systems may be different, the working principle is similar to
that of the accela-cota.

Fig:- A hi-coater system

The machine directs both the coating solution and drying air downwards.

The drying air, then leaves the coating system through the perforations below the coating
drum.

D) Glatt Coater:-
The design of a Glatt coating pan machine resembles that of the accela-cota.
This type of tablet coating machine is known for:

 High spray rates

 Extremely short processing time

Fig:- A tablet coating drum

Its design is such that you can direct the drying air from inside the tablet coating drum.

Normally, the air passes through the tablet bed and leaves via exhaust duct.

Its unique design minimizes turbulence that may occur around the spray nozzle.

This ensures an even distribution of the coating solution on the tablets.

Moreover, its drum has unique geometrical shapes with baffles on the periphery.

This ensures an effective mixing of tablets while protecting the products from damage at the
same time.

So far, it is one of those tablet coating machines that ensures consistent and accurate coating.

As you can see, the working principle of all these tablet coating machines is the same.

For instance, in all the perforated pan systems, the spray nozzle atomizes coating fluid.

Also, the spraying nozzle is in the tablet coating drum.

The only difference is how the machine supplies and removes the drying air.
Now, with this information, am sure you can easily choose a suitable perforated pan system
for your tablet manufacturing process.

Again, in case you don’t need these two, there is another tablet coating machine available in
the market.

This is the:

FLUIDIZED BED COATER:-

A few weeks ago, I did an article on different types of spray systems in fluid bed equipment.

You should spare some time to read this article.

It will give you more insights on this subject.

Fig:- Different positions of spraying nozzles in fluid bed system.

Well, the working principle of fluidized bed or air suspension system is basically similar to
that of the other spraying systems.

Normally, the key aspects about these coating machines are:

 It has a vertical cylinder

 A column of drying air flows upwards suspending all the tablets. This causes the
tablets to move upwards, outwards and then downwards, a process we refer to
as fluidization.
 Spray nozzle atomizes and introduces the coating fluid into a fluidized bed. The
nozzle’s position can either be at the top or bottom of the fluidized bed coater.

This process will continue until you achieve the right coating on your tablets.

Basically, you are at liberty to choose any of the three types of tablet coating machines.
But, before I proceed to the next section, you should remember that the degree of coating
fluid atomization in any of these machines will depend on:

 Type, design and size of the nozzle

 Fluid pressure
 Orifice size

With these in mind, we can have a quick overview of the next classification criteria:

TABLET COATING DEFECTS AND THEIR REMEDIES:-

Coating tablets with a thin polymer film can be an effective way to give your products a
professional edge. High quality tablets can be quickly and easily produced using a tablet
coating machine and the correct excipients . Unfortunately several defects can arise with
coatings. The following list provides helpful remedies for common issues that may be
encountered.

Blistering:-
Definition:-Blistering of a surface film occurs when its elasticity or adhesive properties are
compromised. The result is that the film becomes detached from the tablet’s substrate.

Cause:- Blistering is usually a result of high temperatures that may occur during the drying
process, during the spraying stage or at the end of the coating process

Remedy:- Use mild drying conditions, and ensure moderate temperatures at other stages of
the coating process.

Chipping:-
Definition:- Chipping occurs when the film becomes dented and chipped and this is most
notably visible on the edges of the tablet.

Causes:- Deformity in the tablet cam occur when there is a decrease in the rotation speed in
the machinery during the coating process. Another cause would be a poor polymer or coating
solution – e.g., an incorrect amount of plasticizer is used in the coating solution,.

Remedy:- Increase the hardness of the film by adjusting the proportion of plasticizer in the
coating solution or selecting a polymer with a higher molecular weight.

Cratering:-
Definition:- Cratering happens when a defect on the film’s coating results in craters
appearing on the tablet which in turn results in the exposure of the tablet’s surface.

Causes:-Cratering can occur in certain instances where there is insufficient drying time to
seal the film or a high volume of coating solution is applied. In these cases excess polymer
solution can penetrate to the surface of the tablet, especially in the crown area, causing the
disruption of the coating and degeneration of the tablet’s core.

Remedy:- Check the efficiency of the drying process and optimise drying conditions.
Picking:-
Definition:- Picking happens when part of the film sticks to the pan resulting to some of the
tablet pieces being detached from the core.

Causes:- Picking occurs when there is overwetting of tablets by the polymer solution, making
the film become tacky which results to the tablets sticking to one another.

Remedy:- Overwetting can be avoided by increasing the efficiency of the drying process e.g,
by increasing the air inlet temperature. Alternatively, the rate of applying coating solution can
be decreased, or the solution viscosity increased.

Pitting:-
Definition:- Pitting is the deformation of the core of the tablet without any visible signs of
disruption of the film coating .

Causes:- Pitting can occur when the tablet core becomes hotter than the melting point of the
materials used in its preparation. .

Remedy:- Dispense with preheating procedures at the start of coating and modify the drying
(inlet air) temperature such that the temperature of the tablet core does not become greater
than the melting point of the batch of additives used.

Blooming:-
Definition:- Blooming is the fading or dulling of a tablet colour after a prolonged period of
storage at a high temperature.

Causes:- The tablet colour can become dull as a result of changes in the composition of the
surface film. It is usually the result of using too much plasticiser or of using a plasticiser with
a low molecular weight.

Remedy:- Decrease the concentration and increase the molecular weight of the plasticiser in
the polymer.

Blushing:-
Description:-Blushing is a haziness or appearance of white specks in the film.

Causes:- Haziness or white specks are particles of polymer that has precipitated in the film. It
usually forms as a result of an excessively high coating temperature. Alternatively it may be
formed by gelation of the polymer when used in certain combinations with other materials.

Remedy:- Decrease the drying temperature to avoid precipitation of polymer. Avoid the use
of sorbitol with polymers such as hydroxy propyl cellulose, hydroxy methyl cellulose, methyl
cellulose and cellulose ethers.

Color Variation:-
Description:- Variation in the colour of tablets within a batch.
Causes:- Colour variations may occur by a number of different faults in the preparation e.g.,
poor mixing, uneven spray patterns of the machinery, insufficient coating, migration of
soluble dyes-plasticizers and other additives during drying.

Remedy:- Aim for even geometric mixing, reformulate with different plasticizers and
additives and/or use mild drying conditions.

Infilling:-
Description:- This refers to the filling of intagliations - i.e., the distinctive words or symbols
formed on the tablet.

Causes:- Infilling is caused when a polymer solution that is sprayed onto the table is unable
to disperse. When sprayed with air, bubbles can form in the solution leading to a foam.
Unlike a liquid, foams may accumulate within the intagliations rather than dispersing over the
whole tablet. The result is that droplets of liquid become concentrated in the intagliations.
This leads to a higher concentration of polymer within the intagliations. If the droplets build
up, they can coat the whole pellet giving rise to an uneven polymer film.

Remedy:- Add alcohol to the polymer solution to improve dispersion, or use a spray nozzle
capable of finer atomization.

Orange Peel (Roughness):-

Description:- The tablet has the appearance of an “Orange Peel” on account of having a
rough surface, which may also have a matt rather than glossy texture.

Causes:- Orange peel can be the result of poor tablet composition causing it to become soft.
It can also be caused by too high a spray pressure combined with a fast spray rate, leading to
uneven coating of the tablet.

Remedy:- Use mild drying conditions or use additional solvents to decrease the viscosity of
the polymer solution so that spraying rate can be reduced.

Cracking (Splitting):-
Description:- Cracking occurs when the film coating the tablet cracks in the crown area or
splits around the edges.

Causes:- Cracking occurs when the film’s internal stress exceeds the tensile strength of the
film. This is common with higher molecular weight polymers or polymeric blends.

Remedy:- Use lower molecular weight polymers or polymeric blends. Also adjust plasticiser
type and concentration.

During tablet manufacture, an industrial pharmacist may encounter many problems. Solving
these problems requires an in-depth knowledge of tablet-formulation as well as machine-
operating processes. Some of the more general issues that may be encountered are:

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