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ORG

IMPORTANCE OF FORMULATION
DEVELOPMENT STUDIES
Miss .Madhuri Pandurang Shikhare , Miss.Priyanka Ashok Meher, Miss.Priti Sandip Pawar, Miss.Priti
Balaso Chopade, Miss.punam Kiran Chavan

Institute of pharmaceutical sciences and Research (for girls)(college code- 6914), Pune-Solapur Highway
Swami chincholi (Bhigwan), Tal- Daund, Dist-pune 413130.

Abstract

Preformulation is the term for a set of research studies that concentrate on novel drug candidates and physicochemical
characteristics that may have an impact on the medicine's efcasy and the creat on of a dosage form.This can support the
necessity for molecular change or of ercrucialinformation for formulation design.Prior to developing a pharmaceutical
formulation,the inherent chemical and physical characteristcs of each medicine were taken in to consideraton.This
characteristis of the foundation for combining medications with medicinal components to create dosage forms.The goal of the
preformulation analysis is to createa dose form that is tasteful,reliable,safe,and compatble with other ingredients.It also aims
to determine the physicochemical parameters of novel pharmacological compounds.Medication soluble content,partation
value,dissolution rate,polymorphicforms,and stability are a few of these characteristcs.A novel medicaton is not created in its
whole form when it has been developed.

Keywords : Solid dosages forms,Liquid dosage form,Tablets,Capsules, Equipment

Introducton:
Molecule or active substance is found through scientific investigation. The process of figuring out the optimal way to administer
this active component is called drug formulation. Drug formulation, sometimes referred to as pharma formulation, is the
process of blending several inert ingredients together with the active pharmaceutical component (API) to create a fnished
product for patents.Drug formulation includes not just selecting inactive ingredients to add to the active component but also
determining whether the active component but also determining whether the dosage form-oral soluton, pill, or injecton is
appropriate for the drug.During the course of drug development, drug formulation takes place multiple times.Clinical trial
formulations, formulations for various dosages, and formulas for various delivery routes are available if more than one is
preferred. A synopsis of the medicaton formulaton. Pharmaceutcals are designed with precise dosage forms in mind to ensure
effective product distributon as well as stability. The goal of formulation development is to identfy the best possible dosing
form, content, and manufacturing process for pharmaceutcals.Various types of medicinal dosage forms exist,including :
sustainable drug medication,controlled drug medication,liquids,oral,powders etc.

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History:

Dhanvantari, the Hindu mythological doctor to the gods, created Ayurveda after learning about it from Brahma. The
Atharvaveda, one of the Vedas, has the earliest knowledge of it.The first pharmacological medicine was created in 1804 by
German scientst Friedrich Serturner.The earliest natural remedies, which were found in plants, herbs, and other natural forms,
fungus, roots, and vines. Nature's medicines were the only means of pain relief available to humans until the middle of the
nineteenth century. Chloral hydrate, the first synthetic medicine, was created 1869 and used for its sedative-hypnotic; it still is
accessible today.The inital pharmaceutical enterprises owned much to the textile and synthetic dye industries, and they were
their mirror images.

Definition :
In pharmaceutics, pharmaceutical formulation is the process of combining various chemicals,including the active ingredient, to
create a finished pharmaceutical product. Dosage form is typically included in the definition of the word formulation.

Steps involved in formulation :

1.Preformulation :
Preformulation studies are laboratory investgation to identify the propertes of the active ingredient and excipient that may
have an impact on the design and performance of the formulation process.Pre-formulations are a set of studies that focus on
the physicochemical characteristcs of novel drug candidates and how they interact with excipientst infuence medicinal efficacy.

2.Analytical assay development and characterizaton:

The process of developing an experimental setup for carrying out analytical processes on chemical samples is known as
analytical method development. Drug products meant for commercial manufacturing can be identified, separated, quantified,
and further informaton about their chemical components can be obtained using developed analytical procedures.

3.Partical size analysis and characterization :

Particle size can be determined using a variety of techniques,the most popular being is analysis,laser diffiraction,dynamic lights
catering,and direct imaging approaches.When analysing the same samples,the outcomes of various approaches frequently
show poor correlations with one another.Particle size can be determined using a variety of techniques,the most popular being
sieve analysis,diffraction,dynamic lights catering,and direct imaging approaches.When analysing the same samples,the
outcomes of various approaches frequently show poor correlations.

4.Formulation development :
To obtain the desired features,such as texture,viscosity,stability,and efficacy,formula developers must carefully choose and
combine a variety of raw components,including oils,emulsifers,thickeners,preservatives,scents,and active substances, inprecise
amounts and ratios.

5.Formulation Assessment :
In conclusion,formulations a synthetic phase that involves clinical judgement in the mental assessment process information,the
views of ontological (diagnostchierarchy),causal (biopsychosocialmodel),and meaning(verstehen)unite to provide a
comprehensive picture of aparticular situation as well as a foundation for care and therapy.
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6.Stability study :
Pharmaceuticals and many other regulated consumer products must comply with regulations on product shelflife.Because
pharmaceuticals must adhere to strict rules for determining their shelf life,stability science must be applied
effectively.Pharmaceutcal product labels indicate the shelf life,also known as the expiratiom date or expiry,to guarantee the
product's potency,integrity,and quality when used in the specifed in the frame.Data generated to validate label claims and
authorised by regulatory bodies is used to determine shelf life.Region allaws man date an expiration date to guarantee the
drug product's quality,safety,and efficacy and to guarantee that these and standards are up held for the duration of the
pharmaceutcal product's labelled shelf life.

FORMULATION OF NOVEL DRUG DELIVERY SYSTEM :

1.The conventional drug delivery system : The targeted release system releases the drug in dose form,while the
drug delivery system absorbs the drug across a biological membrane. Forexample,tablets and capsules.Liquids for oral use.
semisolids,such as lotions,creams,and ointments.parenteral, etc.The traditional approaches to delivering medication to the
body are called conventional DDSs.These approaches are typically employed more frequently when the objectve is that the
fast release of a medicine is necessary due to its rapid absorpton.Among the traditional medication delivery methods are basic
techniques that are oral,topical,inhalation,or injectable.

Tablet Composition :
Usually, these comprise five to ten percent active ingredients, eighty percent inert substances, and ten percent compounds
that aid in the breakdown of the item in the digestive system.

Formulation of Capsules : In order to make a capsule, the active ingredient is enclosed in a "shell"composed of a substance that
gels and dissolves in the intestines.

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Formulation of Capsules : In order to make a capsule, the active ingredient is enclosed in a "shell" composed of a
substance that gels and dissolves in the intestines.

Formulation of Oral Liquids :

In addition to being quicker and less costly to create, liquid formulations frequently have higher bioavailability compared to
other oral formulations.

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Ophthalmic preparation :
Ophthalmic preparations are specific dose forms intended for topical application,intraocular administraction,periocular
administraction(such as juxt ascleral or subtenon)administration,or us agein conjunction with anophthalmic device.

Parentals drug delivery :

Medicaton administered by means other than the digestive tract is referred to as a parenterally administered medicaton.Most
commonly, the phrase "parenteral" refers to medication administered via injecton or infusion.Generally speaking, the enteral
route refers to ingesting medication.IM,IN,transdermal,submucosal,subcutaneous(SC),IV,intraspinal,and intracapsule

NOVEL DRUG DELIVERY SYSTEM :

Colloidal carrier :

Colloidal drug carriers,also known as colloidal carriers,efficiently facilitate the delivery of a loaded medication to the intended
location with in the body.They have the power to alter the way related material is distributed,enabling medication
administraction to precises locations and controlled release.This could raise the therapeutic index of these medications by
making them more effective or less harmful.The capacity of the secolloidal carriers to reach target cells(such as the bone
marrow)or stay in the blood stream(controlled release mechanism)determine show effective they are.Rather than relying on
the physicochemical characteristcs of the drug itself,the drug distribution is determined by the
carrier.Liposomes,niosomes,nanospheres,multiple emulsions,and ceramics are examples of colloidal drug carriers.

Liposomes :

Liposomes,niosomes,nanospheres,multpleemulsions,and ceramics are examples of colloidal drug carriers.

Nanosomes:

Many industries,such as chemotherapy,biosensors,bioimaging,cosmetcs,and medical diagnostics,use nanosomes.This chapter

will provide a thorough overview of the developments made in the characterization and formulation of nanosomes for use in
different drug delivery systems.
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Micropartcles :

Additonally,microparticles can help delivery the drug's pay load to the intended location and provide regulated release of the
medication overan extended length of time. Using micro particles can boost the drug's bioavailability while lowering the dosage
and frequency.

Phytosomes:

Phospholipids and naturally occurring active phytochemicals bound in their structures combine to form phytosomes,which are
produced by reacting plant extracts with phosphatidylchoine(or any other hydrophilic polar head group)in an approtic solvent.

Transdermal drug delivery system :

Transdermal drug delivery systems,commonly known as patches,are dosage forms intended to penetrate a patient's skin and
administer a the rapeutically effective dosage of medication.They are also known as medicated adhesive patches,which are
applied to the skin to transfer a prescribed dosage of medication through the skin and into the blood stream.

Nanopartcles : Transdermal drug delivery systems,commonly known as patches,are dosage forms intended to penetrate a
patient's skin and administer a therapeutically effective dosage of medication.They are also known as medicated adhesive
patches,which are applied to the skin to transfer a prescribed dosage of medicationvthrough the skin and in to the blood stream.

Evaluaction Test :
1.Solid dosage form :

i)Dissoluton test :

The process of dissolving an active substance into a solvent and creating a solution is called dissolution oral solid doses usually
start to dissolve and breakdown in the stomach.There resultant mixture enters the small intestine,where the disintegraction
process carries on

ii)Disintegraton Test :

The ability of a tablet to disintegrateing to smaller particles or granules so that the active medication can be absorbed by the
body is measured by disintegration testing.

iii)Weight variaton test :

The purpose of the weight variation test is to verify that the formulation's content is uniform,the tablets are the proper size,and
good manufacturing practices(GMP)are followed(Yoshid a,1999).The parameters for tablet weight variation of intact dose units
are provided by the United States Pharmacopoeia(USP).

iv)Drug uniformity test :

With a specifed permited variation within a batch,these tests are intended to guarantee that each tablet and capsule contains
the same amount of medication component.

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2.Liquid dosage form :

i)Leakage test : 10 containers filled with liquid dosage form and inverted for 24 hours; also check for leakage in cases of rubber
closure.

ii)Clarity test :

Use clean water as a control to dilute the preparations and examine for cloudiness.The test involves observing transparent or
white particles against a black backdrop and black or dark particles against a white background.

iii)Sterility test : It is carried out to find out whether parenteral it emsing clude live types of bacteria,fungus,or
yeast.Maintaining sterility requires careful asceptic handling to prevent unintentional product contamination.

iv)Pyrogen test :

Pyrogens are the metabolic by products of bacteri a that cause fever in the body.

LABELLING AND PACKAGING :

Definiton-The primary functon of packaging is to ensure the product is safe to transport,store, and sell, but labelling provides
necessary informaton about the product using printed text, logos, artwork, or other designs.

Types of packing :

Primary packaging-The primary functon of packaging is to ensure the product is safe to transport, store, and sell, but labelling
provides necessary informaton about the product using printed text, logos, artwork, or other designs.Primary packaging, often
known as consumer or retail packaging, is the package that comes into direct contact with the product.Primary packaging's
major goals are to inform, contain, and/or preserve the consumer.

Secondary packaging -The packaging that keeps a good's constituent components to gether is known as secondary
packaging.Its main purpose is to transport large amounts of the commodity to the point of sale or final consumer;holding the
good is not as important as it is to the primary packing.

Tertary packaging-The third tier of three packing types used to safe guard produced items for storage or transpo rtation is
called tertiary packaging.It serves to safe guard the goods as well as the primary and secondary packing.However,tertiary
packaging has purpose so other than only protection.

Ampoules:

The most prevalent uses for modern ampoules are to hold chemicals and medications that need to be kept safe from airborne
pollutants.By melting the thin top with an open flame,they are hermetically sealed,and they are often opened by breaking of
the neck.

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Packaging materials : A device or material that holds a pharmaceutcal product, whether or not it comes into direct contact
with the substance, is called a pharmaceutcal package container. A sturdy container is required for pharmaceutcal purposes.

Glass : The main ingredients of glass are limestone,soda,ash,and sand.Pure silica glass is composed of a three-dimensional
network of silicon atoms,each of which is tetrahedrally surrounded by four oxygen atoms.

Type 1: Borocilicate glass:E.g., pyrex, borosil

Main constituents: SiO2-80%, Al203-2%, Na2O, Cao-6%

Properties: resistant to chemical substances; reduced leaching action.

Uses: Laboratory glass apparatus, for water injection

Type-2:

Treated soda lime glass:

Main constituents: Made of soda lime glass. The surface of which is treated

with acidic glass like SO2 at elevated tempecture and moisture.

Uses: For alkali-sensitive products, infusion fluids, blood, and plasma; large volume container
Properties: The surface of glass is resistant to attack by water for a period of time

Type 3: Regular soda-lime glass:

Main constituents:SiO2, Na2O, and CaO.
Properties: Flakes separate easily, and many crack due to sudden changes in temperature

Uses:topical use, oral use, not for ampoules.

Type-4 NP (non-parenteralglass or general-purpose soda lime glass)

Uses:topical use, for oral use, not for ampoules.
Main constituents: Sio2 -72 to 75%, B2o3 -7 to 10, Na2o -6 to 8%, K2o -0.5 to 2%, Bao-2 to 4%

Properties: lower cost than borosilicate; they are softer and can easily be moulded.
Uses: small vials (25 ml),large transfusion bottles.

Coloured bottles:

Main constituents:glass and iron oxide

Properties: Produce amber-coloured glass; can resist UV visible radiation from 290–400 nm
Use: for photosensitive products.

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Plastic-General properties of plastics: robust, strong, light, and aesthetic.Plastics are synthetic polymers of high molecular weight.
easy to handle.They are poor conductors of heat, a disadvantage if the content is to be autoclaved.Very few types of plastics
completely prevent the entry of water vapour, and some are permeable to gases like O2, CO2.

Types of plastics: Plastics are classified into two groups according to their behaviour when heated.

Thermoplastic type: On heating, they soften to a viscous fluid, which hardens again on cooling.E.g., polyethylene, polypropylene,
PVC, polystyrene, nylon etc.

Rubber :Longchain polymers of isoprene units joined in the cis direction makeup natural rubber.Its primary source is the Hevea
braziliensis tree,from which latex is exuded when shallow bark cuts are performed.This latex contains 30to40% rubberin colloidal
suspension.

Equipment and instrument handling :

1.Tablet punching machine

A pharmaceutical tablet press is a mechanical device that simplifies powders or granules into tablets of compatible size, shap
e, and weight that contain roughly the same amount of excipient and active pharmaceutical ingredient. It is also referred to a
s a tablet punching machine or tablet compression machine.Pharmaceutical powder formulations can be compressed into
tablet form using a tablet press machine. The tablet compressing machine is another name for this device. Making tablets with
consistent weight, size, and shape is highly helpful

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2.Hardness tester :

This test is also known as the "crushing strength test'.

Tablet hardness has been is defined as the force required to break a tablet in diametric compression.The hardness is measured
in kg/cm2..

3.Fribility Tester :

Friability test tells how much mechanical stress tablet are able to withstand during their manufacturing, distribution and handling
by the customer.
%Friability = W1 - W2/W1×100

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4.Disintegraction tester :

Disintegration is a process in which tablet are break up into granules or smaller particles.The U.S.P. device to test disintegration uses
6 glass tubes that are 3 inch long ; open at the top and 10 mesh screen at the bottom end.One tablet is placed in each tube and the
basket rack is positioned in a 1L beaker of water.Move the basket containing the tablet up and down through a distance of 5-6cm at
a frequency of 28 to 32 cycle per minute.

5.Dissolution tester :
Dissolution test used to throughout the life cycle of pharmaceutical product to evaluate the rate of release of a drug substance
from the dosage form. Dissolution is considered one of the most important quality control tests performed on pharmaceutical
dosage form.It is generally referred to as in vitro -in vivo correlation (IVIVC) .

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