THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid

Dosage Formulations
Reference: Chemical Engineering in the Pharmaceutical Industry; Edited
by M. T. am Ende & D. J. am Ende, 2nd edition, Chapter 2, Wiley, 2019.

34

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Dr. Linda Al-Hmoud

Dosage Forms
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

 Definition
Dosage forms are the means (or the form) by which drug
molecules are delivered to sites of action within the body.
 The need for dosage forms:
1. Accurate dose. 6. Optimal drug action.
2. Protection e.g. coated tablets, 7. Sustained release medication.
sealed ampules. 8. Controlled release medication.
3. Protection from gastric juice. 9. Insertion of drugs into body
4. Masking taste and/or odor. cavities (rectal, vaginal)
5. Placement of drugs within 10. Use of desired vehicle for
35
body tissues. insoluble drugs.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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1
 Types Of Dosage Forms
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Oral
Topical
Rectal
Classified according to
Parenteral
Route of administration
Vaginal
Inhaled
Ophthalmic
Otic
Solid
Semisolid
Physical form
Liquid
36
Gaseous
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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Oral Route
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• The oral route is the most common way of administering drugs.
• Convenient (self‐administered)
• Safe way of drug administration
• More profitable to manufacture than the parenteral dosage forms
that must be administered, in most cases, by trained personnel.
• This is reflected by the fact that well over 80% of the drugs that are
formulated to produce systematic effects are marketed as oral dosage forms.
• Among the oral dosage forms, tablets of various different types are the most
common because of their
• low cost of manufacture (including packaging and shipping)
• increased stability
37
• virtual temper resistance
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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2
 Types of Solid Oral Dosage Forms
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Type of Oral Dosage Form Characteristics
Immediate release tablets Disintegrate in stomach after taken orally
Enteric‐coated tablets to keep tablets intact in stomach and
Delayed release tablets
disintegrate in intestine for absorption
Sustained/controlled release Release drug slowly over a period of time to decrease the
tablets frequency of administration
Tablets are broken by chewing before swallowing with
Chewable tablets
water
Disintegrate in oral cavity without drinking water to form a
Orally disintegrating tablets
suspension for ease of swallowing
Two‐piece capsule shells filled with granules, powders,
Hard gelatin capsules
pellets, sprinkles, semisolids, and oils
Soft gelatin capsules One‐piece capsule filled with oily liquid
38
Sachets Single‐dose unit bag containing granules
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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Steps of Drug Delivery to the Systemic Circulation

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Drug absorption
from the GI tract
Drug is brought • the rate of
into solution in dissolution of
Initial transport of the GI fluids the drug in the
the drug through • the drug should GI lumen
the be capable of )‫(التجويف المعوي‬
Oral can be a
administration of gastrointestinal crossing the
(GI) membrane intestinal rate‐limiting step
tablets in the
membrane into
the systemic absorption of
circulation drugs given
orally.

39

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3
 Fate of Solid Dosage Form Following Oral Administration
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

The slowest of these events
(dissolution and/or absorption)
determines the rate of availability of
the drug from tablet formulation.

40

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Drug Bioavailability
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Bioavailability refers to the extent and rate at which the active
moiety (drug or metabolite) enters systemic circulation, thereby
accessing the site of action.
• Factors affecting the bioavailability of the drug:
• Physical properties
• Chemical properties
• Biopharmaceutical properties
• Design and production of the tablet

Complexity of tablet formulation transferred tablet formulation 41

design from an art to a well‐defined science.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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4
 Good Formulation and TPP
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• A good formulation must be
• bioavailable
• manufacturable
• chemically and physically stable from manufacturing through the end
of shelf life
• meeting many quality standards and special requirements to ensure
the efficacy and safety of the product.
• These formulation goals can be described as the target product
profile (TPP).
• A TPP is a summary of characteristics that, if achieved, will provide
42
optimal efficacy, patient compliance, and marketability.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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Typical Target Product Profile (TPP) for an Immediate

Release (IR) Tablet
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

TPP How Used by a Formulator Typical for IR Tablet
Once a day (QD)
Indications and Examine other products in the same class: examine
Twice a day (BID)
usage improvements
Three times a day (TID)
Dosage and Good to know what is expected before one starts
Oral tablet
administration formulating
Dosage forms and Multiple strengths may be needed depending on the Dependent on drug
strengths population being targeted (adults vs. children) Typically 10–500 mg
Useful if designing an extended release dosage, in which Dependent on drug
Overdosage
overdose (dose dumping) is a possibility
This is up to the formulator and marketing: shape, size, and A tablet with markings and
Description
color of the tablet color
Clinical Helps determine where the drug is absorbed and how fast Dependent on drug
pharmacology the drug must get into solution
How supplied/ Important as most people do not like refrigerated dosage Two‐year room temperature
stored/handled forms shelf life
43
Other potential inputs a formulator may or may not need: Warnings and Precautions, Adverse Reactions, Drug
Interactions, Use in Specific Populations, Drug Abuse and Dependence, Clinical Studies, and Patient Counseling Information.
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 Understanding
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Drug Substance
Properties
Integrating the physicochemical,
mechanical, and biopharmaceutical
properties of a drug candidate is a
prerequisite in developing a robust
and bioavailable drug product that
has optimal therapeutic efficacy.

44

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Physicochemical Properties
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Solubility and Drug Dissolution
Partition Coefficient
Crystal Properties and Polymorphism
Particle Size, Particle Morphology, and Surface Area
Bulk Powder Properties
Melting Point and Hygroscopicity 45

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 Physicochemical Properties

Solubility and Drug Dissolution

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Aqueous solubility dictates the amount of compound that dissolves 
the amount available for absorption.
• A compound with low aqueous solubility could be subject to
dissolution rate‐limited absorption within the GI residence time.
• Dissolution: the dynamic process by which a material is dissolved in a
solvent
• Characterized by a rate (amount dissolved per time unit)
• Solubility: the amount of material dissolved per unit volume of a certain
solvent
• Characterized as a concentration.
• Solubility is often used as a short form for “saturation solubility” 46

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Physicochemical Properties

Solubility and Drug Dissolution

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Saturation solubility: the maximum amount of drug dissolved at
equilibrium conditions.
• Intrinsic solubility: the solubility of the neutral form of an ionizable
drug.

• Dissolution rate is directly proportional to the aqueous solubility, Cs,

and the surface area, A, of drug exposed to the dissolution medium.
• It is common, when developing an immediate release dosage form of
poorly soluble drug, to increase the drug‐dissolution rate by increasing
the surface area of a drug through particle size reduction.
47

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 Physicochemical Properties

Solubility and Drug Dissolution

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• The dissolution rate of a solute from a solution is described by the
Noyes–Whitney equation:

• D is the diffusion coefficient of the drug substance (in a stagnant

water layer around each drug particle with a thickness h
• A is the drug particle surface area
• Cs is the saturation solubility
48
• Ct is the drug concentration in the bulk solution at a given time
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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Dr. Linda Al-Hmoud

Physicochemical Properties

Solubility and Drug Dissolution

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• The dissolution rate, rather than the saturation solubility, is most
often the primary determinant in the absorption process of a
sparingly low soluble drug.
• Determining the dissolution rate is critical.
• The main area for dissolution‐rate studies are
• evaluations of different solid forms of a drug (e.g. salts, solvates,
polymorphs, amorphous, and stereoisomers)
• evaluations of different particle sizes of the drug.
• The dissolution rate can either be determined for a constant
surface area of the drug in a rotating disc apparatus, or as a
dispersed powder in a beaker with agitation (as detailed in
pharmacopeias such as United States Pharmacopeia, etc.). 49

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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 Physicochemical Properties

Partition Coefficient
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Partition coefficient is the relationship between chemical
structure, lipophilicity, and its disposition in vivo.
• The lipophilicity of an organic compound is described in terms of a
partition coefficient, log P
• The partition coefficient is defined as the ratio of the
concentration of the unionized compound, at equilibrium,
between organic and aqueous phases:

50

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Physicochemical Properties

Partition Coefficient
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• For ionizable drugs, the ionized species does not partition into the
organic phase.
• The apparent partition coefficient, D, is calculated from the
following:

• pKa is the dissociation constant.

• The most widely used model of the lipid phase in pharmaceutical 51
studies is the octanol/water system.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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 Physicochemical Properties

Partition Coefficient
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Compounds with log P values between 3 and 6 show good passive
absorption
• Compounds with log P values of less than 3 or greater than 6 often
have poor passive transport characteristics

52

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Physicochemical Properties

Crystal Properties & Polymorphism

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Most drug substances appear in more than one polymorphic form.
• Polymorphs differ in molecular packing (crystal structure), but
share the same chemical composition.
• Polymorphs may exhibit significantly different solubility,
dissolution rate, compactibility, hygroscopicity, physical stability,
and chemical stability
 Polymorphism has a profound implication on formulation
development and biopharmaceutical properties.
53

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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 Physicochemical Properties

Crystal Properties & Polymorphism

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Fishbone Schematic of Physical Property Differences among Polymorphs 54

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Physicochemical Properties

Crystal Properties & Polymorphism

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Higher solubility and faster dissolution rates of the metastable
polymorph (i.e. a higher energy form) may lead to significantly
better oral bioavailability.
• Metastable polymorph tends to convert to a thermodynamically
more stable form over time.
• Conversion from a metastable form to a stable form could lower a
drug's oral bioavailability  inconsistent product quality.
• From a formulating perspective, it is desirable to use the
thermodynamically stable form of the API; however,
biopharmaceutical and processability considerations may dictate
the deliberate selections of a metastable form for processing. 55

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 Physicochemical Properties

Crystal Properties & Polymorphism

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Polymorphic form conversion from the most stable form may still
occur, even when a stable crystal form is chosen for
development.
• Polymorphic transformations can take place during
pharmaceutical processing, such as particle size reduction, wet
granulation, drying, and even during the compaction process and
compression process as each of these processes may add the
56
energy required to move the drug to the unstable form.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
Tel. +962 6 535 5000 | 22882
Dr. Linda Al-Hmoud

Physicochemical Properties

Crystal Properties & Polymorphism

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Seven specific categories of crystal system:
1. Cubic

2. Monoclinic

3. Triclinic

4. Hexagonal

5. Trigonal (or Rhombohedral)

6. Orthorhombic
57
7. Tetragonal
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12
 The Seven Crystal Systems
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

58

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Physicochemical Properties
Particle Size, Particle Morphology, and Surface Area
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Drug/API size
• Drug/API shape
• Drug/API surface morphology

Dissolution • Bulk flow

control
and • Compactability
Chemical • Formulation homogeneity
Reactivity 59
• Surface‐area
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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13
 Physicochemical Properties
Particle Size, Particle Morphology, and Surface Area
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Spherical particles have the least contact surface area and exhibit
good flow
• Acicular particles tend to have poor flow
• Milling of long acicular (or needle) crystals can enhance flow
properties
• Excessively small particles tend to be cohesive and aggravate flow
problems.

60

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Dr. Linda Al-Hmoud

Physicochemical Properties
Particle Size, Particle Morphology, and Surface Area
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Crystal shape and size have been demonstrated to impact mixing
and tabletability.
• L‐lysine monohydrate with plate‐shaped crystals exhibited greater
tabletability than the prism-shaped crystals
• Kaerger studied the effect of paracetamol particle size and shape
on the compactibility of binary mixture with microcrystalline
cellulose, showing that
• Compressibility increased with particle size and irregular crystals
• Compactibility increased with a decrease in particle size.

61

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14
 Physicochemical Properties
Particle Size, Particle Morphology, and Surface Area
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Particle size affects drug content uniformity (CU).
• For low‐dose direct compression (DC) formulations, where drug CU is
of particular concern, the particle size of the drug substance has to be
small enough to meet the US Pharmacopeia requirement on CU.
• For example, Zhang and Johnson showed that low‐dose blends
containing a larger drug particle size (18.5 μm) failed to meet the
USP requirement, whereas a blend containing smaller particle
sizes (6.5 μm) passed.

62

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

Tel. +962 6 535 5000 | 22882
Dr. Linda Al-Hmoud

Physicochemical Properties
Particle Size, Particle Morphology, and Surface Area
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Surface areas of drug particles are important because dissolution
is a function of this parameter (as predicted by the Noyes–
Whitney equation).
• This is particularly true in those cases where the drug is poorly
soluble. Such drugs are likely to exhibit dissolution rate‐limited
absorption.
• For such drugs, particle size reduction (e.g. micronization) is often
utilized to increase the surface area which enhances the dissolution
rate.
• Example: Micronization enhanced the bioavailability of felodipine 63
when administered as an extended release tablet.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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15
 Physicochemical Properties
Particle Size, Particle Morphology, and Surface Area
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Methods to determine particle size and shape include
• Light microscopy
• Scanning Electron Microscopy (SEM)
• Sieve analysis
• Various electronic sensing‐zone particle counters

• Methods available for surface area measurement include

• Air permeability
64
• Various gas adsorption techniques
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
Tel. +962 6 535 5000 | 22882
Dr. Linda Al-Hmoud

Physicochemical Properties

Bulk Powder Properties

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Density and porosity are two important pharmaceutical
properties that are derived from the information on particle size,
particle shape, and surface area.
• A comparison of true particle density, apparent particle density,
and bulk density can provide information on total porosity,
interparticle porosity, and intraparticle porosity.
• Generally, porous granules dissolve faster than dense granules,
65
since pores allow water to penetrate more readily.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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16
 Physicochemical Properties

Bulk Powder Properties

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

bulk density
Interparticle (interspace) porosity = 𝟏 −
apparent particle density
apparent particle density
Intraparticle porosity = 𝟏 −
true particle density
bulk density
Total porosity = 𝟏 −
true particle density
• The increase in bulk density of a powder is related to the cohesivity of a
powder. Bulk density and tapped density are used to calculate
compressibility index and Hausner ratio, which are measures of the
propensity of a powder to flow and be compressed. 66

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Physicochemical Properties

Bulk Powder Properties

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• A rule of thumb:
a compressibility index of higher than 30% indicates poor
powder flow.
• The Hausner ratio varies from about 1.2 for a free‐flowing powder
to 1.6 for cohesive powders.
tapped density
Hausner ratio =
bulk density
Compressibility (Carr Index)
𝟏𝟎𝟎 × (tapped densit𝒚 − bulk density) 67
=
bulk density
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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17
 Physicochemical Properties

Bulk Powder Properties

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Compressibility index (per cent)
Flow character Hausner ratio

1–10 Excellent 1.00–1.11

11–15 Good 1.12–1.18
16–20 Fair 1.19–1.25
21–25 Passable 1.26–1.34
26–31 Poor 1.35–1.45
32–37 Very poor 1.46–1.59
> 38 Very, very poor > 1.60 68

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Physicochemical Properties

Melting Point and Hygroscopicity

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Low melting materials tend to be more difficult to manufacture
and handle in conventional solid dosage forms.
• A rule of thumb:
melting points below about 60 °C are considered to be
problematic.
• Temperatures in conventional manufacturing equipment, such as
fluid‐bed dryers and tablet presses, can exceed 50 °C.
• During the milling process, hot spots in the milling chamber may
69
have much higher temperatures.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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18
 Physicochemical Properties

Melting Point and Hygroscopicity

THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Moisture uptake is a concern for pharmaceutical powders and is
known to affect a wide range of properties, such as powder flow,
compactibility, and stability.
• On the other hand, moisture may improve powder flow and
uniformity of the bulk density as well as an appropriate amount of
moisture may act as a binder to aid compaction.
• Thus, knowledge of the type and level of moisture is critical for
understanding its impact not only on deformation behavior but
70
also on the attributes of the final product.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
Tel. +962 6 535 5000 | 22882
Dr. Linda Al-Hmoud

Biopharmaceutical Properties
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Biopharmaceutics: the study of the relationships between the
physicochemical properties, dosage forms, and routes of
administration of drugs, and its effect on the rate and extent of
absorption in the living body.
• Complete oral absorption occurs when the drug has a maximum
permeability coefficient and maximum solubility at the site of
absorption, which results in rapid and uniform pharmacological
response.
 A key objective in designing a rational oral dosage form is having sound
understanding of multitude of factors including physicochemical
properties of the drug and dosage‐form components, and physiological
71
aspects of GI tract.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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19
 Biopharmaceutical Properties
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Generating formulations with relevant oral bioavailability depends
on a number of factors: Absorbability is related to
1. Solubility the first two factors:
2. Permeability Solubility and Permeability

determines the ability of drug

to move across the lipophilic intestinal
membrane in gastrointestinal tract (GIT).
3. Metabolic stability
refers to ability of a drug to withstand metabolism or degradation 72
in the gut wall and the liver.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
Tel. +962 6 535 5000 | 22882
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Biopharmaceutical Properties
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Drugs and drug candidates are classified into four categories based on their solubility and
permeability properties:
Solubility
High Low
Permeability
Class I: Class II: Formulation are designed to
No major challenges for overcome solubility
immediate‐release dosage form. Salt formation, Precipitation inhibitors
High Controlled‐release dosage forms Metastable forms, Solid dispersions
may be needed to limit rapid Lipid technologies,
absorption Particle size reduction
Class III: Class IV: Formulation would have to use a
Prodrugs combination of the approaches identified in
Permeation enhancers Class II and III.
Low Ion pairing Strategies for oral administration are not
Bioadhesives really viable. Often use alternative delivery 73
methods such as intravenous administration.
Chemical Engineering Department | University of Jordan | Amman 11942, Jordan
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20
 Mechanical Properties
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Material mechanical properties play a role in manufacturing drug
product.
• Particle properties influence the true areas of contact between particles
and can affect unit operations, such as compression, milling, and
granulation.
• Characterization of mechanical properties of drug substance is
important in three areas:
• Choosing a processing method, such as granulation or DC
• Selecting excipients with properties that mask the poor properties of the
drug
• Helping to document what went wrong, i.e. when a tableting process is
being scaled‐up or when a new bulk drug process is being tested.
It is to the formulator's advantage to quantify and understand the
mechanical properties of the active and inactive ingredients. 74

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Mechanical Properties
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

• Pharmaceutical materials are like metals, plastics, or wood:
Elastic Plastic Viscoelastic Hard Tough Brittle

• The same concepts that materials/mechanical engineers use to

explain/characterize tensile, compressive, or shear strength are
relevant to pharmaceutical materials.

• A number of characterization tools are available for understanding

the mechanical properties of the material.
75

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21
 Mechanical Properties

Characterization Tools
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Quasi‐Static Testing Dynamic Testing
API required 1–100 g 2–10 g
“Independently” dissect out Understand the mechanics of
and investigate various materials at speeds
Advantages
mechanical properties representative of production
tablet compaction
Cannot determine properties at Difficult to factor out the
Limitations representative production individual mechanical property
scales “component”
76

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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Mechanical Properties

Characterization Tests
THE UNIVERSITY OF JORDAN

Topic 2 - Design of Solid Dosage Formulations

Quasi‐Static Testing Dynamic Testing

Tensile strength Force–displacement profiles

Indentation/dynamic
hardness Tablet volume–applied
pressure profiles
Young's modulus
Heckel equation
Tablet porosity–applied pressure
Tableting indices function 77

Chemical Engineering Department | University of Jordan | Amman 11942, Jordan

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22