6. Mission Statement
To ensure quality Education as a fundamental right of every student.
Vision Statement
To provide quality education to students and graduates without charging, with
dignity.
Values
• Transparency
• Respect for People
• Integrity
• Patient Focused
10. Speaker’s point of view, not reflecting
DRAP or any other regulatory body
Pure science with references
You are welcome to correct if we are
wrong.
11. TABLET
The solid unit dosage form of medicament
or medicaments with suitable excipients
and prepared either by molding or by
compression.
12. EXCIPIENTS
An excipient is a substance formulated alongside the active ingredient of
a medication
Pharmaceutical regulations and standards require that all ingredients in
drugs, as well as their chemical decomposition products, be identified
and shown to be safe.
Excipients are used to facilitate the manufacture and use of medicines
Excipients are known to significantly influence the processability,
aesthetics, performance, and/or patient compliance associated with a
dosage form.
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15. CLASSIFICATION OF EXCIPIENTS
making thinner or less concentrated. For example Lactose, Spray dried
lactose, Micro crystalline cellulose (Avicel 101 and 102), Pvpk30 (Pearlitol
SD200 and 25C), Sorbitol, Dibasic calcium phosphate dehydrate, Calcium
sulphate dehydrate
DILUENT
Binder excipients are formulated to act as an adhesive to literally “bind
together”. For example gelatin, cellulose, cellulose derivatives,
polyvinylpyrrolidone, starch, sucrose and polyethylene glycol.
These are used to convert fine powder into granules for example
water,alcohol,mucilage of starch,mucilage of acacia ,mucilage of
tragacanth,gelatin solution,iso-propyl alcohol,acetone etc.
Lubricants prevent ingredients from clumping together and from sticking
to the tablet punches or capsule filling machine. For example vegetable
stearin, magnesium stearate or stearic acid
BINDER
GRANULATING
AGENT
LUBRICANTS
16. CLASSIFICATION OF EXCIPIENTS
which causes them to disintegrate and release their medicinal substances
on contact with moisture. For example polyvinylpyrrolidone
(crospovidone), crosslinked sodium carboxymethyl cellulose
(croscarmellose sodium), and the modified starch sodium starch
glycolate.
DIS-
INTEGRANT
sweeten and mask the taste. The most common sweeteners were:
sucrose (sugar) (53.4%), sodium saccharin (38.3%) and sorbitol (36.9%).
Twenty-one medicines (28,7%) contained two sweeteners.
Flavours are used as additives to enhance, modify the taste and the
aroma in drug products which could have got lost due to drug processing
SWEETNERS
FLAVORING
AGENT
23. PHYSICAL INTERACTIONS
Physical interaction between an API and an excipient is that between
primary amine drugs and microcrystalline cellulose. When dissolution is
carried out in water a small percentage of the drug may be bound to the
microcrystalline cellulose and not released.
a tablet has been administered to the patient, the aqueous environment
of the gastrointestinal tract (GIT) either causes the smaller API particle or
other carrier particles to dissolve or causes the surface interactions to
change to allow the smaller particles to be released from the larger
carrier particles
24. CHEMICAL INTERACTIONS
Chemical interactions between drug and excipients. Primary amine group
of chlorpromazine undergoes Maillard reaction with glycosidic hydroxyl
group of reducing sugar dextrose to form imine, which finally breakdown
to form Amidori compounds
In one another study it was observed that release of diclofenac sodium
from matrix tablet was inhibited by polymer chitosan at low pH, most
possibly via formation of ionic complex between diclofenac sodium and
ionized cationic polymer (Block et al., 1997).
25. CHEMICAL INTERACTIONS
Primary amines may interact with double bonds in a reaction analogous
to a Michael addition reaction (e.g., fluvoxamine maleate, where the
fluvoxamine primary amine group can interact with the double bond in
the maleic acid counterion). Examples of excipients that contain double
bonds include sodium stearyl fumarate and sorbitan monooleate
Suspending agents such as sodium alginate dissolve in water to form large
negatively charged anions, co-formulation in aqueous systems with drugs
such as neomycin and polymixin ( active mioties of which are positively
charged) result in precipitation
26. knowledge of drug–excipient interactions is a necessary prerequisite to the
development of dosage forms that are stable and of good quality. It is hoped that
this review provides some perspective of this important area of pharmaceutical
technology.
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31. HOME WORK 1
A patient is diabetic, which excipient to be
avoided during formulation of oral solid dosage
form and liquid formations
Answer to be sent @ 0333-2243031 by Monday
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36. HOME WORK 2
For wet granulation, which solvent is NOT used?
Justify your answer with scientific rationale.
Answer to be sent @ 0333-2243031 by Monday