DEFINTIONS

1. Forced degradation is a process that involves degradation of drug products and drug
substances at conditions more severe than accelerated conditions and thus
generates degradation products that can be studied to determine the stability of the molecule.

2. Polymorphism is the ability of a solid material to exist in more than one form or crystal
structure. Polymorphism can potentially be found in any crystalline material including
polymers, minerals, and metals, and is related to allotropy, which refers to chemical elements.

3. New Molecular Entities (NMEs) are compounds that emerge from the process of
medicine discovery, that are not a version or derivative of an existing, previously
investigated/approved substance. They have promising activity against a particular target
thought to be important in a disease, however, little is known about the efficacy, safety,
toxicity, pharmacokinetics and metabolism in humans. A full development programme of
non-clinical and clinical trials must be performed to evaluate the potential of an NCE to
become a medicinal product.

4. New chemical entity (NCE) is, according to the U.S. Food and Drug Administration, a
drug that contains no active moiety that has been approved by the FDA in any other
application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

5. Disintegration is defined as that state in which any residue of the unit, except fragments
of insoluble coating or capsule shell, remaining on the screen of the test apparatus or adhering
to the lower surface of the discs, if used, is a soft mass having no palpably firm core.

6. Dissolution test is a means of identifying and proving the availability of active

pharmaceutical ingredient (API) in their delivered form. A dissolution test reflects the
availability of active substance and allows the prediction of the time for complete release of
the material from the dosage form.

7. Stereochemistry, a sub discipline of chemistry, involves the study of the relative spatial
arrangement of atoms that form the structure of molecules and their manipulation. The study
of stereochemistry focuses on stereoisomers, which by definition have the same molecular
formula and sequence of bonded atoms (constitution), but differ in the three-dimensional
orientations of their atoms in space. For this reason, it is also known as 3D chemistry—the
prefix "stereo-" means "three-dimensionality

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8. Tonicity is a measure of the effective osmotic pressure gradient, as defined by the water
potential of two solutions separated by a semipermeable membrane. In other words, tonicity
is the relative concentration of solutes dissolved in solution which determine the direction
and extent of diffusion. It is commonly used when describing the response of cells immersed
in an external solution.

9. Osmotic pressure is the minimum pressure which needs to be applied to a solution to

prevent the inward flow of its pure solvent across a semipermeable membrane. It is also
defined as the measure of the tendency of a solution to take in pure solvent by osmosis.

10. Potential osmotic pressure is the maximum osmotic pressure that could develop in a
solution if it were separated from its pure solvent by a semipermeable membrane.

11. Diffusion is the net movement of molecules from a region of higher concentration to a
region of lower concentration. Diffusion is driven by a gradient in chemical potential of the
diffusing species.

12. Disintegration test this test determines whether dosage forms such as tablets, capsules,
boluses pessaries and suppositories disintegrate within a prescribed time when placed in a
liquid medium under the prescribed experimental conditions. For the purpose of this test,
disintegration does not imply complete solution of the dosage unit or even of its active
constituent. Disintegration is defined as that state in which no residue of the unit under test
remains on the screen of the apparatus or, if a residue remains, it consists of fragments of
disintegrated parts of tablets component parts such as insoluble coating of the tablets or of
capsule shells, or of any melted fatty substance from the pessary or suppository or is a soft
mass with no palpable core. If discs have been used with capsules, any residue remaining on
the lower surfaces of the discs consists only of fragments of shells.

13. Calibration is a comparison between a known measurement (the standard) and the
measurement using your instrument. Typically, the accuracy of the standard should be ten
times the accuracy of the measuring device being tested. ... For the calibration of the scale,
a calibrated slip gauge is used.

14. The Common Technical Document (CTD) is a set of specification for application
dossier for the registration of Medicines and designed to be used across Europe, Japan and
the United States

15. Quality control is an essential operation of the pharmaceutical industry. Drugs must be
marketed as safe and therapeutically active formulations whose performance is consistent and
predictable. New and better medicinal agents are being produced at an accelerated rate. At the
same time more exacting and sophisticated analytical methods are being developed for their

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evaluation. Requirements governing the quality control of pharmaceuticals in accordance
with the Canadian Food and Drugs Act are cited and discussed.

16. Quality assurance is a good practice in the manufacture of pharmaceutical products, as it

is the process of vouching for integrity of products to meet the standard for the proposed use.
It is an obligation that ensures manufacturers meet the needs of end-user needs in terms of
safety, quality, efficacy, strength, reliability and durability. Quality is a benchmark of
perfection for the end-user.

17. Pharmaceutical analysis is a branch of practical chemistry that involves a series of

process for identification, determination, quantification and purification of a substance,
separation of the components of a solution or mixture, or determination of structure of
chemical compounds.

18. Friability is the tendency for a tablet to chip, crumble or break following compression.
This tendency is normally confined to uncoated tablets and surfaces during handling or
subsequent storage. Friability testing is a laboratory technique used by the pharmaceutical
industry to test the durability of tablets during transit. This testing involves repeatedly
dropping a sample of tablets over a fixed time, using a rotating wheel with a baffle.

19. Validation is the process of establishing documentary evidence demonstrating that a

procedure, process, or activity carried out in testing and then production maintains the desired
level of compliance at all stages. In the pharmaceutical industry, it is very important that in
addition to final testing and compliance of products, it is also assured that the process will
consistently produce the expected results.[1] The desired results are established in terms of
specifications for outcome of the process. Qualification of systems and equipment is
therefore a part of the process of validation. Validation is a requirement of food, drug and
pharmaceutical regulating agencies such as the US FDA and their good manufacturing
practices guidelines. Since a wide variety of procedures, processes, and activities need to be
validated, the field of validation is divided into a number of subsections including the
following:

 Equipment validation
 Facilities validation
 HVAC system validation
 Cleaning validation

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 Process Validation
 Analytical method validation
 Computer system validation
 Packaging validation
 Cold chain validation

Similarly, the activity of qualifying systems and equipment is divided into a number of
subsections including the following:

 Design qualification (DQ)

 Component qualification (CQ)
 Installation qualification (IQ)
 Operational qualification (OQ)
 Performance qualification (PQ)

20. Glidant is a substance that is added to a powder to improve its flowability. A glidant will
only work at a certain range of concentrations. Above a certain concentration, the glidant will
in fact function to inhibit flow ability. In tablet manufacture, glidants are usually added just
prior to compression.

21. Tablet binders are used in the formulation of solid oral dosage forms to hold the active
pharmaceutical ingredient and inactive ingredients together in a cohesive mix. Binder
products are usually differentiated based on the manufacturing process to be used. Binders
are one of the most essential elements in the formulation of a tablet. Because they promote
cohesiveness, the binders, also called adhesives, help the other ingredients in a tablet to mix
together. Tablet binders are used to turn powder to granules; this is achieved through the
process of granulation. During granulation, powder substances are accumulated to form
larger particles called granules.
Starch Paste, Pregelatinized Starch (PGS), Hydroxypropyl Methyl Cellulose (HPMC),
Polyvinyl Pyrrolidone (PVP), Acacia, tragacanth, gelatin, starch paste,cellulose, ethyl
cellouse, mehyl cellulose, poly vinyl alcohols.

22. Granulation is the process of forming of grains or granules from

a powdery or solid substance, producing a granular material. It is applied in several
technological processes in chemical and pharmaceutical industry. Typically, granulation

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involves agglomeration of fine particles into larger granules, typically of size range between
0.2 and 4.0 mm depending on their subsequent use. Less commonly, it involves shredding or
grinding solid material into finer granules or pellets.

When powdery particles or granules are intended for compression into a tablet, they must
have two important properties:

1. Flow property – tablets should be a consistent weight and uniform strength

2. Compressibility – tablets should remain intact, compact, and stable, even when
pressure is applied
3. Before undergoing the granulation process, these properties can be achieved by
adding binders to the formulation. Binders should be utilised if a tablet displays poor
fluidity and compressibility.

Aside from those mentioned above, granulation can also help to achieve the desired tablet
appearance, avoid dustiness, improve mixing properties, decrease segregation, eliminate
undesirable properties, and finally, to improve the physical and chemical properties of the
powder. Following are the granulation types,

Dry granulation

Wet granulation

Melt granulation

Foam granulation

Steam granulation

23. Antiadherents: Antiadherents are used to reduce the adhesion between the powder
(granules) and the punch faces and thus prevent sticking to tablet punches. They are also used
to help protect tablets from sticking. Most commonly used is magnesium stearate. Binders:
Binders hold the ingredients in a tablet together.

24. Binders ensure that tablets and granules can be formed with required mechanical
strength, and give volume to low active dose tablets. Binders are usually:  Saccharides and
their derivatives: o Disaccharides: sucrose, lactose; o Polysaccharides and their derivatives:
starches, cellulose or modified cellulose such as microcrystalline cellulose and cellulose

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ethers such as hydroxypropyl cellulose (HPC); o Sugar alcohols such as xylitol, sorbitol or
maltitol;  Protein: gelatin;  Synthetic polymers: polyvinylpyrrolidone (PVP), polyethylene
glycol (PEG)...

Binders are classified according to their application: 

 Solution binders are dissolved in a solvent (for example water or alcohol can be used
in wet granulation processes). Examples include gelatin, cellulose, cellulose
derivatives, polyvinylpyrrolidone, starch, sucrose and polyethylene glycol. 
 Dry binders are added to the powder blend, either after a wet granulation step, or as
part of a direct powder compression (DC) formula. Examples include cellulose,
methyl cellulose, polyvinylpyrrolidone and polyethylene glycol.

25. Coatings: Tablet coatings protect tablet ingredients from deterioration by moisture in the
air and make large or unpleasanttasting tablets easier to swallow. For most coated tablets, a
cellulose ether hydroxypropyl methylcellulose (HPMC) film coating is used which is free of
sugar and potential allergens. Occasionally, other coating materials are used, for example
synthetic polymers, shellac, corn protein zein or other polysaccharides. Capsules are coated
with gelatin

26. Disintegrants: Disintegrants expand and dissolve when wet causing the tablet to break
apart in the digestive tract, releasing the active ingredients for absorption. They ensure that
when the tablet is in contact with water, it rapidly breaks down into smaller fragments,
facilitating dissolution.

27.Fillers: Fillers fill out the size of a tablet or capsule, making it practical to produce and
convenient for the consumer to use. By increasing the bulk volume, the fillers make it
possible for the final product to have the proper volume for patient handling. A good filler
must be inert, compatible with the other components of the formulation, non-hygroscopic,
relatively cheap, compactible, and preferably tasteless or pleasant tasting. Plant cellulose
(pure plant filler) is a popular filler in tablets or hard gelatin capsules. Dibasic calcium
phosphate is another popular tablet filler. A range of vegetable fats and oils can be used in
soft gelatin capsules. Other examples of fillers include: lactose, sucrose, glucose, mannitol,
sorbitol, calcium carbonate, and magnesium stearate.

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28. Flavours: Flavours can be used to mask unpleasant tasting active ingredients and
improve the acceptance that the patient will complete a course of medication. Flavourings
may be natural (e.g. fruit extract) or artificial. For example, to improve:  a bitter product -
mint, cherry or anise may be used  a salty product - peach, apricot or liquorice may be used
 a sour product - raspberry or liquorice may be used  an excessively sweet product - vanilla
may be used

29. Colours: Colours are added to improve the appearance of a formulation. Colour
consistency is important as it allows easy identification of a medication

30. Lubricants: Lubricants prevent ingredients from clumping together and from sticking to
the tablet punches or capsule filling machine. Lubricants also ensure that tablet formation and
ejection can occur with low friction between the solid and die wall.Common minerals like
talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic acid are the most
frequently used lubricants in tablets or hard gelatin capsules. Lubricants are agents added in
small quantities to tablet and capsule formulations to improve certain processing
characteristics.

There are three roles identified with lubricants as follows:

1. True Lubricant Role:  To decrease friction at the interface between a tablet’s surface and
the die wall during ejection and reduce wear on punches & dies.

2. Anti-adherent Role:  Prevent sticking to punch faces or in the case of encapsulation,

lubricants  Prevent sticking to machine dosators, tamping pins, etc.

3. Glidant Role:  Enhance product flow by reducing interparticulate friction.

There are two major types of lubricants:

1. Hydrophilic Generally poor lubricants, no glidant or anti-adherent properties.

2. Hydrophobic Most widely used lubricants in use today are of the hydrophobic category.
Hydrophobic lubricants are generally good lubricants and are usually effective at relatively
low concentrations. Many also have both anti- adherent and glidant properties. For these
reasons, hydrophobic lubricants are used much more frequently than hydrophilic compounds.

Examples include magnesium stearate.

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31.Glidants: Glidants are used to promote powder flow by reducing interparticle friction and
cohesion. These are used in combination with lubricants as they have no ability to reduce die
wall friction. Examples include fumed silica, talc, and magnesium carbonate. Sorbents:
Sorbents are used for tablet/capsule moisture-proofing by limited fluid sorbing (taking up of a
liquid or a gas either by adsorption or by absorption) in a dry state. Materials used for enteric
coatings include fatty acids, waxes, shellac, plastics, and plant fibers.

32.Preservatives: Some typical preservatives used in pharmaceutical formulations are: o

Antioxidants like vitamin A, vitamin E, vitamin C, retinyl palmitate, and selenium o The
amino acids cysteine and methionine o Citric acid and sodium citrate[disambiguation needed]
o Synthetic preservatives like the parabens: methyl paraben and propyl paraben.

33. Sweeteners: Sweeteners are added to make the ingredients more palatable, especially in
chewable tablets such as antacid or liquids like cough syrup. Sugar can be used to mask
unpleasant tastes or smells.

34. Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA)
that may be used to provide confidential detailed information about facilities, processes, or
articles used in the manufacturing, processing, packaging, and storing of one or more human
drugs. The information contained in the DMF may be used to support following,
– Investigational New Drug Application (IND),
– New Drug Application (NDA),
– Abbreviated New Drug Application (ANDA),

35. Active substance is any substance or mixture of substances intended to be used in

the manufacture of a medicinal product and that, when used in its production, becomes
an active ingredient of that product intended to exert a pharmacological, immunological or
metabolic action

36. Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a
drug substance, generally, but not necessarily, in association with one or more other
ingredients. ... Inactive ingredient is any component other than an active ingredient.

37. Drug substance is an active ingredient that is intended to furnish pharmacological

activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of
disease or to affect the structure or any function of the human body

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38. An active pharmaceutical ingredient is defined in ICH Q7 as “any substance or mixture
of substances intended to be used in the manufacture of a drug product and that, when used in
the production of a drug, becomes an active ingredient in the drug product

39. Pharmaceutical formulation, in pharmaceutics, is the process in which different

chemical substances, including the active drug, are combined to produce a final medicinal
product. The word formulation is often used in a way that includes dosage form.

40. LD50 (lethal dose) is the dose of any substance tested required to kill half the number
(50%) of test animals. The test shows how much of a substance must be taken before it
becomes deadly. Since different chemicals cause different toxic effects, comparing the
toxicity of one with another is hard. We could measure the amount of a chemical that causes
kidney damage, for example, but not all chemicals will damage the kidney. We could say that
nerve damage is observed when 10 grams of chemical A is administered, and kidney damage
is observed when 10 grams of chemical B is administered. However, this information does
not tell us if A or B is more toxic because we do not know which damage is more critical or
harmful.

Therefore, to compare the toxic potency or intensity of different chemicals, researchers must
measure the same effect. One way is to carry out lethality testing (the LD50 tests) by
measuring how much of a chemical is required to cause death. This type of test is also
referred to as a "quantal" test because it is measures an effect that "occurs" or "does not
occur".

41.List of evaluation tests for tablets: evaluation tests were done to know the quality of the
tablets, some of the tests were listed below

a.Thickness and diameter

b.Weight variation

c.Hardness

d.Friability

e.Drug content

f.Disintegration time

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g.In- vitro dissolution and its Kinetics studies

191410991979

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