This document discusses various dosage forms used in pharmaceutical manufacturing. It begins by defining active pharmaceutical ingredients (APIs) and excipients. It then describes different types of solid, liquid, and semisolid dosage forms including tablets, capsules, powders, solutions, suspensions, emulsions, creams, ointments, pastes, elixirs, and syrups. Specific details are provided about tablet ingredients and manufacturing processes like compression and coating. Overall, the document provides a comprehensive overview of common dosage forms and how drugs are formulated into products for administration.
I Omkar B. Tipugade , M-Pharm, Sem 4th , Department of Pharmaceutics , Shree Santkrupa College Of Pharmacy, Ghogaon. Today I published the hard gelatin & Soft Gelatin Capsule in brief .
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
A brief description of pharmaceutical dosage forms and their route of administration and typical process flow and manufacturing details. It may help new aspirants who wnts to knoiw aboute dosageforms and their administration routes.
I Omkar B. Tipugade , M-Pharm, Sem 4th , Department of Pharmaceutics , Shree Santkrupa College Of Pharmacy, Ghogaon. Today I published the hard gelatin & Soft Gelatin Capsule in brief .
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
A brief description of pharmaceutical dosage forms and their route of administration and typical process flow and manufacturing details. It may help new aspirants who wnts to knoiw aboute dosageforms and their administration routes.
The means (or the form) by which drug molecules are delivered to sites of action within the body.
The drugs are rarely administered in their original pure state. They are administered in different dosage forms after converting them into a suitable formulation.
The dosage form is a combination of the drug and different kinds of non-drug compounds called “additives”.
PHARMACEUTICAL DOSAGE FORMS : an overall introduction .pptxAdinathSangale2
Dosage forms are the mechanism by which drug molecules / APIs are administered to areas of action inside the body to generate maximum intended benefits and the lowest unwanted effects.
OR The Dosage form is the combination of Active Pharmaceutical Ingredients (API) and Excipients in the formulation.
ORAL ROUTE OF DRUG ADMINISTRATION_Dr. Jeenal Mistry.pdfDr Jeenal Mistry
Oral Dosage Form practical session mainly for undergraduate students, those are learning competency based with PH 2.1: Demonstrate an understanding of use of various dosage forms(Oral/Local/Parenteral ;Solid/Liquid)
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•Describe the advantages and disadvantages of various dosage forms
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Tablets: a.Introduction, ideal characteristics of tablets, Classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems.
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5. • Tablets:-
– They are unit solid dosage
forms consisting of active
ingredient and suitable
pharmaceutical excipients.
– They may vary in size, shape,
weight, hardness, thickness,
disintegration and dissolution
characteristics, and in other
aspects.
6. Capsules:-
• They are unit solid dosage forms
consisting gelatin shell that
breaks open after the capsule has
been swallowed and releasing the
drug.
• Types-
hard-shell gelatin capsule
soft-shell gelatin capsule
7. 1. soft gelatin shell manufactured in one
piece with drug usually in liquid form
inside the shell, e.g. fat-soluble vitamins A
and E, Procardia (nifidepine), etc.
2. hard shell manufactured in two pieces
that fit together and hold the drug, either
in powdered or granular form.
8. lozenges :-
tablets formed from hardened base or sugar and water
containing drug and other flavors.
They are designed to dissolve slowly
in the mouth and release the drug topically to the tissues
of mouth and throat; they are not to be swallowed.
9. Powder:-
• They are bulk solid dosage forms
consisting two or more
medicament meant for internal
use.
• The size of particle range from
10,000 microns to 0.1microns.
• Size of the powder determine the
effectiveness of physiological
properties.
11. • Semisolids contain both liquids and solids semi-solid.
• dosage forms that are too soft in structure to qualify for
solids but too thick to be considered liquid.
• They are meant for topical application.
Creams: -
Creams are semi-solid emulsions, that is mixtures of oil
and water.
They are divided into two types-
1.O/W TYPE
2.W/O TYPE
12. A.O/W creams:-
• which are composed of small droplets
of oil dispersed in a continuous
aqueous phase.
• cosmetically acceptable as they are
less greasy and more easily washed
off using water.
B.W/O creams:
• which are composed of small droplets
of water dispersed in a continuous oily
phase.
• Water-in-oil creams are more difficult
to handle.
• Water-in-oil creams are also more
moisturising as they provide an oily
barrier which reduces water loss from
the stratum corneum,the outermost
layer of the skin.
13. Ointment/Pastes
• Pastes are semisolid dosage forms
that contain one or more drug
substances intended for topical
application.
• Generally, pastes contain a higher
proportion of solid materials than
ointments.
• They are more stiff, less greasy, and
more absorptive of serous secretions
when used on the skin.
• Medicated dental pastes are also
prepared for adhesion to the mucous
membranes for local effect.
14.
15. Elixirs:-
solutions that contain an alcohol and water base, added sugar and
flavorings, e.g. Tylenol; commonly used for pediatric and elderly
patients who have difficulty swallowing tablets or capsules.
Syrups:-
do not contain alcohol and are concentrated solutions of sugar,
water, and flavorings. They are sweeter and more viscous than elixirs.
Most OTC cough medications are syrup based and don’t only carry
the drug but also act to soothe the inflamed mucous membranes of
the throat.
Solutions:-
one homogenous phase, prepared by dissolving one or more
solutes in a solvent.
Emulsions:-
-a dispersion system consisting of two immiscible liquids
-o/w or w/o
-cloudy appearance.
Suspensions:-
A dispersion system where solid particles are dispersed in liquid
phase
• Solid particles called dispersed phaes and liquid called
continuous phaes.
o
w
16. Liniments
• Liniments are alcoholic or
oleaginous solutions,
suspensions, or emulsions
of medicinal agents
intended for external
application to the skin,
generally by rubbing.
18. Inhalations
• Inhalations are finely
powdered drug
substances, solutions, or
suspensions of drug sub-
stances administered by
the nasal or oral
respiratory route for local
or systemic effects.
• Special devices are used
to facilitate
administration.
Thanks to a new insulin inhaler, researchers say, the daily injections many
diabetics take may become relics of the past.
19. aerosol sprays
- Several different types
of pharmaceutical
product may be
packaged in
pressurized
dispensers, known as
aerosols.
- used as surface
disinfectants, wound or
burn dressing, relieve
irritation of bites.
20.
21. Tablets
• Tablets are oral solid unit dosage form of medicaments
with or without suitable diluents and prepared either by
molding or compression. They are solid, flat or biconvex
disc in shape.
•They vary greatly in shape, size and weight which
depend upon amount of medicament used and mode of
administration.
•They also vary in hardness, thickness, disintegration
and dissolution characteristics and in other aspects
depending upon their intended use and method of
manufacture
•They are used for local & systemic effect.
• Usually used for oral administration
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22. Advantages
– Large scale production at
lowest cost
– Easiest and cheapest to
package and ship
– High stability
– Easy to handling
– Easy to administration
– Lightest and most compact
– Tablets are formulated as a
special release of products
such as enteric or delayed
release products.
23. Disadvantages
• It’s not suitable for poorly
water-soluble or poorly
absorbable drugs, less
bioavailability.
• Drugs that are sensitive to
oxygen or may also require
special coating.
• Enhances local irritant effect
of some drugs or cause harm
to the gastrointestinal mucosa
26. 9/9/2015 26
They use to make required bulk of the tablet .
to provide better tablet properties such as to improve cohesion,
to permit use of direct compression manufacturing
to improve flow
Ex:-
1. Lactose, sucrose, mannitol; frequently used, water soluble,
improves tablet disintegration.
2.Dicalcium phosphate dihydrate, insoluble in water,
disintegrating agent is a must.
3. Mannitol, dextrose, sucrose,
4. Lactose-anhydrous and spray dried lactose
5.Directly compressed starch-Sta Rx 1500
6. Hydrolyzed starch-Emdex and Celutab
7. Microcrystalline cellulose-Avicel (PH 101, 102)
Filler or diluent
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Role: to ensure that the tablet, when in contact with a liquid, breaks up
into small fragments, which promotes rapid drug dissolution.
Mode of action:
1. Facilitate water uptake into the pores of tablet,
e.g. surface active agents
2.facilitate rupture of tablet by swelling during water sorption,
e.g. Sodium –starch glycolate, Crosscarmelose- cross linked cellulose;
modified cellulose, Ac-Di-Sol
3. Release of gases to disrupt the tablet structure, normally carbon
dioxide, in contact with water. e.g. effervescent tablets.
Disintegrant
28. 9/9/2015 28
Role: Ensure that granules and tablets can be
formed with the required mechanical strength.
( glue that holds powders together to form
granules )
Examples:
starch paste 5-25%
gelatin solution 10-20%,
gum acacia, tragacanth, 10-25%
Liquid glucose 50%,
Cellulose derivative
Polyvinylpyrrolidone 2% (PVP), PEG
Binder and adhesive
29. 9/9/2015 29
Role: Lubricants
prevent adherence of granule/powder to die wall and promote
smooth ejection from the die after compaction, reduce inter particle
friction and improve the rate of flow of the tablet granulation.
Lubricant
Glidant
Role: Improve flowability of the powder
They are added during direct compaction and to granulation
before tabletting ( they reduce interparticulate friction).
Ex.-
1. Talc (at concentration 1-2 %).
2. Colloidal silica (0.2 %).
3. Corn Starch 5-10%
30.
31. Stages of pharmaceutical manufacturing
API
Excipients
Primary
Packaging
Secondary
Packaging
API Finished
Product
Starting Materials
(Chemicals)
32. Processing routes
Fill die
Coating, Packaging etc..
Compress Tablet
Direct Compression
Drug
Diluent
Glidant
Disintegrant
Lubricant Mixing
Mixing
Dry Granulation
Disintegrant
Glidant
Lubricant
Drug
Diluent
Lubricant
Mixing
Compression
Comminution
Screening
Mixing
Mixing
Wetting
Granulation
Drying
Screening
Mixing
Drug
Diluent
Binder
Solvent
Disintegrant
Glidant
Lubricant
Wet Granulation
Other Routes
Fluidized bed granulation
Extrusion / rotary granulation
Tablet
Compression
33. Tablet compression machines
• Hopper for holding and feeding granulation to
be compressed
• Dies that define the size and shape of the
tablet
• Punches for compressing the granulation
within the dies
• Cam tracks for guiding the movement of the
punches
• Feeding mechanisms for moving granulation
from the hopper into the dies
36. Multi-station rotary presses
• The head of the tablet machine that holds the
upper punches, dies and lower punches in
place rotates
• As the head rotates, the punches are guided
up and down by fixed cam tracks, which
control the sequence of filling, compression
and ejection.
• The portions of the head that hold the upper
and lower punches are called the upper an
lower turrets
37.
38.
39. The way to get started is to quit talking &
being doing.. – Walt Disney.