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.

1. A VIEW OF
PHARMACEUTICAL
DOSAGE
FORMS
BY: RAVINDRA KUSHWAHA

2. TYPE OF DRUGS
• A drug that is sold by a company with a specific name
or tradename and drug is protected by a patent.
Brand/Proprietary Name Drugs
• Generic medicines use the same active ingredients as brand-
name medicines and work the same way, so they have the same
risks and benefits as the brand-name medicines (FDA).
• Any drug marketed under its chemical name without
advertisement comes under the generic drugs categories.
• Generic drug can be only sold after drugs patent expired.
Generic Drugs

3. ROUTE OF ADMINISTATION
Routes of administraation
Systemic Routes
Gastro systemic routes
1. Oral
2. Sublingual
3. Rectal
Parenteral
1. Intravenous
2. Intramuscular
3. Subcutaneous
4. Intra-arterial
5. Intra-articular
6. Intrathecal
7. Intradermal
8. Intraperitoneal
Local Routes
Local routes
1. Skin Topical
2. Intra Nasal
3. Ocular Drops
4. Inhalation
5. Transdermal
4. Mucosal
a. Throat
b. Vagina
c. Mouth
d. Otic (Ear)

4. • Administration route of medication, nutrition or
other substance into the circulatory system to
impact the body through the systemic routes.
• Administration of medicaments through the mouth
(absorption of the drug through the
gastrointestinal tract) like OSD, OLD, etc.
• Administration of medicaments through the intra
systemic routes (parenteral) act to systemic
circulation (generally injection, infusion, or
implantation).
• Local Administration is a route of administration
of medication or other substances which act
locally and affect the applied part of body.
• Administration can take via Skin, Ear, Eye, Nose,
Vagina, etc.
ROUTE OF ADMINISTATION

5. ORAL SOLID DOSAGE FORMS
1. Tablets
• Tablets are commonly used pill in round, oval or square
shape. Oral Solid dosage form or containing unit dose
of one or more medicament.
• Tablets manufactured by compression method.
• Different types of excipients added into the tablet to
improve quality, physical strength and appearance.
• Binders, glidants (flow aids) and lubricants to ensure
efficient tableting.
• Disintegrants to ensure that the tablet breakup in the
digestive tract.
• Sweeteners or flavors to mask the taste of bad-tasting
active ingredients.
• Pigments to make uncoated tablets visually attractive.
• A coating may be applied to hide the taste of the
tablet's components, make the tablet smoother and
easier to swallow , make it more resistant to the
environment, extending shelf life.

6. ORAL SOLID DOSAGE FORMS
a. Sublingual Tablets & Buccal Tablets
• Sublingual Tablets are placed between the
cheek and gum or below the tongue.
• The buccal tablet is placed high up along your
top gum, under the upper lip either side of
your mouth.
• This route used to avoid void the acid and
enzymatic environment of the stomach and the
drug metabolizing enzymes of the liver.
• The medications dissolve rapidly and are
absorbed through the mucous membranes of
the mouth, where they enter the blood stream.
• Do not eat, drink, smoke, or use chewing
tobacco while a tablet is dissolving.
Nitroglycerin sublingual tablets usually give
relief in 1 to 5 minutes.
• Examples of drugs administered by this route
e.g., vasodilators, steroidal hormones.

7. ORAL SOLID DOSAGE FORMS
b. Effervescent Tablet
• Effervescent tablets are uncoated tablets that
generally contain acid substances (citric and tartaric
acids) and carbonates or bicarbonates, and which
react rapidly in the presence of water by releasing
carbondioxide.
• They are intended to be dissolved or dispersed in
water before use providing very rapid tablet
dispersion and dissolution.
• Pleasant tasting carbonated drink.
c. Chewable Tablets
• Chewable tablets are an oral dosage form intended
to be chewed and then swallowed by the patient
rather than swallowed whole.
• They should be designed to be palatable and be
easily chewed and swallowed e.g., vitamin products
and Antacids.

8. ORAL SOLID DOSAGE FORMS
2. Capsules
• Capsules are containing lifesaving medicaments, vitamins,
minerals and other healthy constituents via supplements.
• Gelatin or hydroxypropyl methyl cellulose (HPMC) used as
capsule shells.
a. Hard Gelatin Capsules (HGC)
• HGC contains dry powder, granules, pallets and liquid too.
• Dry granulation and capsule filling machine with metal
detector and polisher used for the manufacturing of capsule.
• New concept of HGC used for filling of liquid medicaments.
SGC have not good solubility in water & HGC easily soluble.
b. Soft Gelatin Capsules (SGC)
• SGC used for oils and for active ingredients that are
dissolved or suspended in oil.
• Mixing tank, gelatin slurry tank and capsule filling machine
required for manufacturing of capsule.

9. ORAL SOLID DOSAGE FORMS
3. Lozenges
• It is a solid preparation
consisting of sugar and gum, the
latter giving strength and
cohesiveness to the lozenge and
facilitatings low release of the
medicament.
• It is used to medicate the mouth
and throat for the slow
administration of indigestion or
cough remedies.
4. Pestilles
• They are solid medicated
preparations designed to
dissolve slowly in the mouth.
They are softer than lozenges
and their bases are either
glycerol and gelatin,or acacia
and sugar.
5. Dental Cones
• A tablet form intended to be
placed in the empty socket
following a toothextraction, for
preventing the local
multiplication of pathogenic
bacteria associated with tooth
extractions. The cones may
contain anantibiotic or antiseptic
6. Pills
• Pills are oral dosage forms
which consist of spherical masses
prepared from one or more
medicaments in corporated with
inert excipients

10. OSD MANUFACTURING PFD
Dispensing
of Raw
material
Shifting
of RM
Granulation
(Dry/Wet)
Drying
(FBD)
Blending
/Mixing
Dry
Milling
Tablet
Press
Inspection
&
Coating
Blending
/Mixing
Direct
Compression
Capsule
Filling
Empty
Capsules
Polishing
A typical process flow of Tablets and capsule filling line.
After every process IPQC test required to check the critical parameters.
Testing &
Inspection
Packing
(Blister/
Strip/
Bottle)
Market
Testing,
Inspection
&
Coating
Packing
(Blister/
Strip/
Bottle)
Market
Testing &
Inspection
Packing
(Blister/
Strip/
Bottle)
Market

11. SOFT GELATIN ENCAPSULATIONS
Dispensing
of Raw
material Gelatin
Preparation
Encapsulation
Shape
Formation
& Drying
Testing &
Inspection
Polishing,
Shorting,
Printing
Packaging
(Blister/
Bottle)
Market
Medicaments
Preparation

12. ORAL
SOLID
DOSAGE
FORMS
SIZE

13. ORAL LIQUID DOSAGE FORMS
Solution: One or more equired medicaments dissolved in suitable vehicles to
prepare clear oral solutions.
Emulsion: Oil in water or water in oil mixed together with medicaments and
suitable emulsification agent to stabilize the formulation from phase separation.
Suspension: Oral use of liquid solution containing one or more medicaments that
are suspended in a suitable vehicle with the help of suspending agents.
Syrup: Concentrated aqueous sugar solution is usually sucrose solution contains one
or more medicament to prepare syrups.
Elixir: It is pleasantly flavored clear liquid oral preparation of potent or nauseous
drugs.
Linctuses: Viscous liquid oral preparations that are usually prescribed for the
relief of cough. Contain a high proportion of syrup and glycerol which have a
demulcent effect on the membranes of the throat.
Oral Drops: Oral drops are Liquid preparations for oral use that are intended to
be administered in small volumes with the aid of a suitable measuring device. They
may be solutions, suspensions or emulsions.
Mouth washes: These are like gargles but are used for oral hygiene and to treat
infections of the mouth.
Gargles: They are aqueous solutions used in the prevention or treatment of throat
infections.

14. • Oral liquid solution prepared in vessels filtered through the filters and
filled in to the washed and dried container with heat sealing and capping.
ORAL LIQUID MANUFACTURING PROCESS
Dispensing
of Raw
material
Mixing
of Sugar
in Vessel
Mixing of
Medicament &
addition of sugar
solution in Vessel
Bulk
Testing
Filtration
Solution
Hold
Bottle
Washing,
Drying
Solution
Filling in
Bottles
Bottle sealing
& Capping
Seals
&
Caps
Inspection,
Labeling &
Packing
Market

15. 1. Ointments: These are the external use preparation, applied to the skin,
nasal mucosa or rectum. Typically, they are oily/greasy and semisolid
preparation, usually anhydrous and immiscible with skin secretions.
2. Paste: It is the type of ointment, a mixture of dry powder/solids
suspended in water-oil mixture. Pastes are thick soft sticky substance so
that less penetrating, less macerating and less heating than ointment.
Pastes make particularly good protective barrier when placed on the
skin.
3. Creams: Creams are semi-solid emulsions, approx. equal amount of oil
and water mixture. They are divided in to two types:
➢ Oil-in-water (O/W) creams are composed of small droplets of oil
dispersed in a continuous aqueous phase. Are more comfortable
and cosmetically acceptable as they are less greasy and more
easily washed off using water.
➢ Water-in-oil (W/O) creams are more difficult to handle but many
drugs which are in corporate into creams are hydrophobic and will
be released more readily from a water in-oil cream than an oil-in-
water cream.
TOPICAL DOSAGE FORMS
Dispensing
of Raw
material &
Mineral
Oil
Oil Phase
Preparation
Water Phase
Preparation
Cream
MFG
&
Testing
Cream
Filling &
Sealing
Tube
Capping
Empty Tubes
Caps
Inspection Labeling Packing Market

16. ORAL LIQUID DOSAGE FORMS
Dusting Powder: Bentonite, kaolin, kieselguhr, magnesium carbonate, starch,
and talc are used as inert bases for dusting powders. Powder bases absorb
secretions and exert a drying effect, which relieves congestion and imparts a
cooling sensation. These are free flowing very fine powders for external use
only, not for use on open wounds unless the powders are sterilized.
Liniment: Liniment or Embrocation is a mixture of many medicaments in
oil, alcoholic solution of soaps or emulsion in liquid or semi-solid forms
intended to apply on the skin to treat minor aches and pains of the
muscles/joints (such as arthritis, backache, sprains). (E.g., counter-irritant).
Liniments should not be applied to broken skin.
Lotion: This is the low-viscosity thick, smooth preparation designated to
be applied to the skin for medicinal or cosmetic purposes. Lotions are
used for allergies are meant instead to simply smooth, moisturize, soften
and, sometimes, perfume the skin.
Paint: Paint preparations which contains volatile solvent and glycerin
that evaporates quickly to leave a dry film of medicine and intended to
apply on the skin and other mucous membranes to fasten healing.
Skin paint mainly prepared of volatile solvent that evaporates rapidly
to leave a dry resinous film of medicament.
Throat paint highly viscous preparation contains glycerol very much,
designed to prolong contact of the medicament to affected site.

17. RECTAL DOSAGE FORMS
Suppository: This is small round or cone shaped
medicated mass/object. That is inserted either
into the rectum (rectal suppository), or urethra
(urethral suppository) where it melts at body
temperature and release the medication.
Enema: Also known as clyster, is the procedure of
introducing liquids into the rectum and colon via
the anus for constipation and bowel cleaning.

18. 1. Pessaries: this is a prosthetic device
inserted into the vagina to treat stress
urinary incontinence to stop urinary
leakage, and pelvic organ prolapse to
maintain the location of organs in the
pelvic region. It can be a route of
administration of medication and
provides a slow and consistent release of
the medication. Pessaries are of varying
shapes and sizes.
2. Vaginal Cream: A vaginal cream
is cream for treating vaginal infections,
applied with a special applicator.
Vaginal cream is put into an applicator
before being applied in the vagina.
Vaginal cream to treat vaginal infections
is administered using an applicator
provided by the manufacturer. used for
the treatment of infection or menopause.
VAGINAL DOSAGE
FORMS

19. PARENTERAL DOSAGE FORM
A parenteral dose is a sterile liquid that is injected into the body to the systemic circulation, the
dose can’t be taken through mouth or elementary canal. Dose injected, usually with a hollow
needle and syringe which is pierced through the skin to a sufficient depth at a proper angle for
the material to be forced into the body.
Parenteral drug route of administration:
1. Intravenous (IV) Injection: Injection or infusion Injected directly into the veins (systemic
circulation) for rapid onset of action.
2. Intramuscular (IM) Injection: Drug deliver deep into the muscles used as a drug delivery
technique. Medication may either be absorbed quickly or more gradually depending on
their chemical properties. Vaccines & some injections are mainly given through this route.
3. Subcutaneous (SC) Injection: Subcutaneous means under the skin, a short needle used to
introduce the medication into the tissue between skin and muscle. This layers are highly
effective in administration of vaccines and insulin.
4. Intradermal (ID) Injection: Medication injected into the dermis, generally used for allergic
and tuberculosis testing, Skin layers have limited blood supply than the other tissues so that
medication absorbed slowly after intake.
5. Implants: Man made devices are implants, in contrast to a transplant, which is a
transplanted biomedical tissue.

20. Class C
Solution
preparation
vessel
WFI
(Ambient)
Filtration &
Sol. Hold
vessel Under
LAF
Filling, Stoppering &
Sealing
Under LAF
Vial stoppers & seals
CIP&SIP CIP&SIP
Leak
Inspection
Quarantine
Class CNC
Class B
Autoclave
Vial De-
pyrogenation
Filled Vial
Collection
Formulation Filteration, Sol. Hold & Filling
Vial washing
Class D
FG Store &
Market
Visual
Inspection
Labelling &
Packing
PARENTERAL DOSAGE FORM
Dispensing of
Raw material
under LAF
Class D
Filters, Parts, Stoppers
& Seals
A typical process flow of parenteral manufacturing process based on criticality of product.
IPQC/micro
sampling &
Testing
IPQC/Micro
Sampling &
Testing
Generally, 4 type of parenteral preparation available in the market based on their physical properties:
1. Liquid Solution Parenteral 2. Suspension Solution Parenteral
3. Emulsion Solution Parenteral 3. Dry Powder Parenteral

21. PARENTERAL DOSAGE FORM
Types of parenteral based on volume
1. SVP (Small Volume Parenteral): The volume
of filled solution is less than 100 mm (label
claim). Generally, IV, IM, ID and SC dosage
are manufactured under SVP. SVP may be
packed in Glass Containers (vials, ampules,
PFS) and Plastic containers (PP or PE).
2. LVP (Large Volume Parenteral): The volume
of filled solution in container is more than
100 ml (label claim). Generally, IV and some
eye washes manufactured under LVP. LVP
may be packed in Glass bottles, PP bottles
or PE bottles as per suitability &
requirements of regulatory markets.
Small Volume
Parenteral (Glass)
Small Volume
Parenteral (PP/PE)
Large Volume
Parenteral (Glass)
Large Volume
Parenteral (PP/PE)

22. OPTHALMIC & OTIC DOSAGE FORM
• Eye Drops: Eye drops are most often saline solutions with
medication in that to treat the various conditions of eye.
Generally, these are sterile preparations.
• Eye Ointment & Gel: These are sterile semi-solid
preparations intended for application to the conjunctiva or
eyelid margin.
Dispensing
of RMs and
PPM
Mixing of
RMs with
water in
Vessels
IPQC &
Filtration
of
solution
(0.2 µ)
Solution
Hold
(Vessel)
Online
Filtration
Filling,
Dropper and
capping
Leak Test
& Visual
Inspection
IPQC
sampling
&
Quarantine
Labeling
&
Packing
Warehouse
to market
• Ear drops (otic drops) are a type of medicines in form of
solutions, suspensions or emulsions used to treat or
prevent ear infections, especialy infections of outer ear
and ear canal (ototis externa).
Ear drops also help to remove ear wax. It is used for short-
term treatment and can be purchased over-the-counter or with
a prescription.

23. NASAL/RESPIRATORY DOSAGE
FORM
Inhaler: Inhalers are a device holding medicines in form of solutions,
suspensions or emulsion in a mixture of inertpropellants held under
pressure in an aerosol dispenser. The valve is actuated by finger
pressure, in other types the valve is actuated by the patient breathing
in through the mouthpiece.
It is commonly used to treat asthma and other respiratory problems.
Nebulizer: A nebulizer is a device used to convert medicament in to
mist to treat the intreating asthma, and other respiratory diseases. It
pumps air or oxygen through a liquid medicine to turn it in to a vapor,
which is then inhaled by the patient.
Nasal Drops: Medicaments containing solution may be instilled into the
nose from a dropper or from a plastic squeeze bottle.
The use of oily nasal drops should be avoided because of possible
damage to the cilia of the nasal mucosa.
Nasal Spray: Liquid containing medicament intended to help relieve of
stuffiness (congestion) of nose caused by colds, flu or hay fever.

24. NASAL/RESPIRATORY DOSAGE FORM PROCESS
A typical process flow of Metered Dose Nasal spray

25. ☺
ABBREVIATION
• LAF – Laminar Air Flow
• IPQC – In Process Quality Control
• PE – Polyethylene
• PP - Polypropylene
• PPM – Primary Packing Material
• RM – Raw Material
• WFI – Water For Injection