VETRNARY DOSAGES

FORMS

What's mean by veterinary dosage

forms ?
The medication used for treatment ,
diagnosis purpose or curing the
diseases in animals are known as
veterinary dosage forms.

For your knowledge

Animals are not like humans
Animals having different species
as below.
o Herbivorous
Eg. Horse, sheep, goats
o Omnivorous
Eg. Pig
o Carnivorous
Eg. Dogs, cat

BETWEEN-SPECIES
DIFFRENCES
A. Comparative physiology of digestive
systems.
B. Skin type
C. Respiration
D.Behavior

Comparative physiology of digestive

systems.

Every species having differences bet

there digestive systems
Eg.
Pigs, Dog, Cats having intestinal PH
5.3
Horse having intestinal PH 7

Skin type
The drug formulation for topical use
between species difference might be
expected because of nature of skin.
Eg.
cows, Dog, Cats not having ability
to sweat profusely
Pigs have extensive layer of
keratin
6

Respiration
Important for successful inhalation
therapy
The absorption of drug by respiration
depends upon the drug, particle size,
inspiration volume and rate
Eg.
Respiration rates of birds varies form
46 to 380 respiration/min
Horse:- 12/min
cow :- 30/min
7

Behavior
Water loving breeds shows
problems.
Cat are constant groomers, any
drug substance applied topically
likely to be injected.
Even disinfectant and other
chemicals causes toxicity

Physiological
consideration

1.Drug sensitivity
2.Age
3.Sex
4.Pregnancy
5.Disease states
9

Drug sensitivity
Variation in the drug sensitivity due
to species difference

Eg. Dioxithion is highly sensitive in

bull than other

10

Age
New born animals susceptible to
toxic effect by many depressant &
stimulant of CNS
New born having deficiency in drug
elimination
New born having more water content
as compare to mature animal uit
affect the drug distribution
11

Sex
Drug metabolism varies by sex as
male or female

Eg. male rats having the high rate of

metabolism as compare to female
rats

12

Pregnancy
Pregnancy causes dehydration

It affect the distribution of the drug

Due to this factors drug formulation
for animal in pregnancy state taken
in consideration
13

Disease states
Distribution of drug affected by
disease state like renal failure, heart
failure, dehydration..

This is the physiological condition

taken in consideration

14

Reason
Animal health past few years become more essential
for the following reasons
1. According to Animal Health Institute, domestic
sales survey 4.32 billion dollars priced.
2. Zoonosis the diseases of animals may
secondarily transferred to humans.
In 1960 and 1970 two pharmacy colleges offered the
courses in agricultural pharmacy and veterinary
therapeutics
University of Iowa college of pharmacy
South Dakota university

Some pharmacological agents that

are used exclusively in animals
1) Xylazine: sedative, analgesic

2)
3)
4)
5)

Detomidine: preanasthetic medication

Acepromazine: preanasthetic medication
Flunixin: anti-inflammatory
Azeperone: preanasthetic medication

16

 Some of the drugs can not be used in

animals, those are
chloramphenicol,
diethylstilbestrol and
vancomycin.

CLASSIFICATION OF VETERINARY
DELIVERY DEVICES
Because of the variety of dosage forms in
veterinary medicine and the diversity of animal
and bird species treated, drug or dosage
delivery sometimes requires the development
of specific devices to ensure fast, safe, effective
and low cost efficient treatment.
i. Oral devices
ii. Topical devices
iii. Parental devices
iv. Nasal devices
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1. Oral devices
a. Balling guns
b. Esophageal delivery devices
c. Drench syringes
d. Liquid drench guns
e. Powder drench guns
f. Paste Dispensers
g. Water medication metering devices
h. Rumen lodging devices
i. Hollow bits
j. Non pyloric passage devices
k. Miscellaneous oral dose dispensers
l. Buyoant devices
m. Prolonged release devices
19

2. Topical devices
a. Pour on, spot on application
b. Dust bags
c. Spray race and dip
d. Teat dip
e. Aerosol Dispensers
f. Flea and tick collars
g. Percutaneous devices
20

3. Parenteral devices
Single dose syringe
Syringes are used to express the hydrated
OTC Free Injection Formula through the
back of the Valve and into the palm.

Fig. 16: single dose syringe

21

Automatic syringes
The vial holder model
of
this
automatic
syringe is often used
for
vaccination
or
injection of swine.

Fig. 17: Automatic syring

Multi compartment syringes
Multi-compartment
syringe for storing two
or more substances in
separate compartments.
Fig. 18: Multi compartment syringe

22

 Pole mounted syringe : Used for remote

administration of medicaments. Long needles are
used which are secured on housing that supports
the needle to prevent its breakage.
Mastitis syringes : Drug formulation can be
delivered to the site of infection in a cow with
mastitis. Needles can be inserted directly into the
mammary gland through the teat canal.
Jet injectors : Dose of liquid medicaments is
expelled under extremely high pressure against
epidermis of the animals. Used to vaccinate a
large number of animals and birds.
Projectile delivery system : Used to deliver
drug parenterally from a distance.
23

4.Implanting devices
Three types of Implanting devices are used in
veterinary practices:
Pellet Implanting devices
Ball Implanting devices
Molten Implanting devices

24

 Implants: These are generally smaller and are

designed to implant beneath the surface of the
skin subcutaneously or intramuscularly.
Fig. 18: Implants

25

Intrauterine drug dispenser

Used for local and systemic effect in animal for
local effect prostaglandins, anti fertility agents,
oxytocic agents are used. Drugs with short
biological half life can be used.
Vaginal drug dispenser
Used
for
synchronization
of
estrus.
Synchronization will increase productivity. E.g.
flurogestone acetate, medroxy progesterone
acetate as sponge. Miscellaneous syringes It
includes:
Gas powdered hypodermic syringe
Motor actuated syringe
Flexible needle syringe
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5.Nasal devices

Used for delivery of vaccines as

solutions or powders. It includes:
i. Automatic single or multiple dose
syringe
ii. Single dose dropper vial
iii. Spray dispensers
iv. Powder mist dispensers
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Rational Dosage Forms

Form economical view point the best
way to administered drug would be
in natural solids or liquid forms
Why medication are dispensed in a
form other to an their natural states.
Some drug required protection form
atmospheric oxygen & moisture
28

Formulation of drug dosages forms for

animals

Solid
Liquid oral
Parenteral
Pastes
Pellets and
Implants

29

Solid Dosage forms

There are many similarities and differences in the

anatomy and physiology of mammals, birds and
humans
Tablets and boluses:
These are less popular for animals because of their
administration may be time consuming, hazardous, uncertain
in tablet swallowing, and they may spit out or dropped from
the mouth.
This can be overcome by use of acceptable odors, flavors,
sweeteners.
Tablet advantages over other dosage forms low
manufacturing
cost,
stability,
palatability
problems, uniform dosage and convenience in
packaging

Solid Dosage Forms

Odour
Flavour
Sweetner
By using this improve acceptance of
tablet
By chewing animals crushed the
tablets
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Flavors that animals

prefer include
Dog prefers Beef, Chicken, Peanut
Butter, Liver, Raspberry, Strawberry.
Cat prefers Tuna, Chicken, Beef, Cheese,
Peanut Butter, Liver, Butterscotch.
Bird prefers Grape, Orange, Tutti-Frutti.
Horse prefers Apple, Creamy Caramel,
Molasses, Licorice, Cherry.

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Solid Dosage Forms

Dosing based on weight
Eg. cow required high dose so we cant
prescribe 15 gm of drug for each 150 lb of
body weight. Thus 600 lb cow would
required 60 gm drug. So this is
complicated
To Overcome this problems : capsule
shaped or cylindrical shaped tablet
commonly called BOLUS
The instrument used to hold and drop it in
to animal mouth is balling guns
Its difficult to give horse but useful in cow
33

34

 Drugs are given on the basis of weight or body surface

area
The labeling of solid dosage forms, must be stated in
mg or g per kg of body weight
A special tablet BOLUSE is commonly used to provide
the large doses, it can range from 3 to 16 gm in weight
Boluses are capsule shaped or cylindrical
Boluses are administered by an apparatus called balling
gun, consisting of a barrel with a plunger that can hold
one or more boluses
The tube inserted in to the animal mouth over the base
of tongue and such animal swallows the plunger is
depressed.
The bolus is expelled in to the gullet of animal, after it
swallowed by reflex

 Bolus formulation poses challenges because of the high to excipients ratio

Less room left for diluents, binders and other additives
Cattle or sheep, possible to utilize the concept of long acting boluses, which
stays in GIT more than 12 hrs.
The density is the critical factor to maintain the retention

Feed additives
Feed additive premix (type A) are formulated to contain bulk drug and excipient
in a form that may ready combine with an animal feed
The feed route is using for mainly prophylactic purpose and growth promotion of
animal . The most of the premixes contains
grain carrier
Rice hulls
Corn germ meal
Corn meal
Corn gluten
In which active drug is lightly bound or absorbed on the surface, the carrier
functions by absorbing the small particles of drug on the surface, The carrier
usually be two thirds or more in concentration .

 An oil may be added to bind the drug and the

carrier
To prevent caking , an anti caking agent such
as silicon dioxide or magnesium aluminium
silicate can be incorporated
factor considered in formulation
1.
2.
3.
4.
5.

Drug concentration
Moisture content of drug and carrier
Electrostatic charges
pH
Flow of powders

Drinking water medications

The medications formulated as
1.
2.

Dry powders for reconstitution

Concentrated solutions

Unhealthy animals allow to drink water

continuously.
Water as medium for drug solubility and quick
absorption.
Concentration of drug in water to be half only, this
problem may overcome by its limited solubility.
The powder medication is dissolved at the time of
administration in to water to make a stock
solution

 In addition, the dry powders are usually

formulated with sugar as lactose or dextrose.
The use of these may cause a build-up of
bacteria and fungi in water lines
The drug stability in water must be stated in
label

Oral Liquid Dosage Form

Solution and Suspension
Mostly used as aqueous solution
If drug substance is not soluble in water
the
o Co-solvant
o Surfactant
o Solubiliser
o Complexing agent
Or vegetable oil are used
40

Suspension
Useful for drug which having lack of
solubility
By add suspending agent suspension
was prepared
Mostly preffered to aqueous
suspension
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Parenteral Dosage Form

Parenteral dosage forms
Aqueous, organic and oily solutions
Emulsions
Suspensions
It prepared same as human
Indeed many products of human given animal without any
modification
It must be
Sterile
Free form pyrogen
42

Paste
Its more convenient to pets like cats,
dogs
Its injected in the mouth due to
paste its not come out easily and
absorb in mouth

43

Oral pastes and gels

Semi fluid masses can be administered from a flexible
tube, syringe or using device
Advantage of these are cannot be expelled out animal
mouth.
Medication may be readily and easily with a paste.
A proper consistency to adheres to the tongue or buccal
cavity.
Characteristics of pastes
1. when placed in palm and hand is inverted it should
remain without falling
2. When ejected fro applicator, should break cleanly
3. No paste should continue to ooze from applicator
4. Free from air bubbles

 Three types of vehicles used in formulation of

paste and gels are
1. Aqueous bases
2. Oil or oleaginous bases
3. Organic solvents
Aqueous base is the least expensive vehicle and
poses no toxicity
Glycerin, glycols, natural or synthetic gums,
polymers used to increase the viscosity,
cohesiveness and plasticity
To overcome the separation of water gel, can use
absorbing materials like MCC, kaolin, colloidal
silicone dioxide, starch

Oleaginous bases consists of vegetable oil with

aluminum monostearate, colloidal silica, and
xanthan gum
Glycerin , propylene glycol and poly ethylene
glycol thicked with carboxy vinyl polymers
provide organic bases

Pallet & Pallet implants

For long acting hormone therapy
Solution is clean & flow readily
This implant inside the body of animal
Pellets implants
The subcutaneous implantation of a tablet
or pellet will provide a long acting hormone
therapy. Pellets implanted on the dorsal
surface of a cows ear are used for
controlling estrous, improving growth and
enhancing feed efficiency. Pellet implants of
diethylstilbesterol were used in caponising
47
poultry.

Mastitis Products
Mastitis has been define as inflammation
of mammary gland due to infection by
bacterial or mycotic pathogens
When it occurs in sheep, cow, it greatest
economical because it reduces the milk
production
It overcome by systematic administration
of an antibiotic by topical or therapautic
treatment
48

Drenches and tubing products

Horses are administered certain medications by running
lubricated tube up through the nostrils and down in to
stomach
A funnel attached to the tube is held above the horses
head and liquid medication is poured down the tube.
Known as tubing
Normal dose by this method is 10 OZ
Wetting agents are used to increase the flow rate.
Thicking and suspending agents are contraindicated to
resist the flow
The administration of drug to animals by pouring a
liquid medication down an animal throat is called
drenching

Topical dosage forms

Four types of topical dosage forms are
1.
2.
3.
4.

Pour on /spot on applications

Dust bags
Dips
Flea and tick collars

Pour on/spot on applications

These are the liquid products effect systemic activity after being poured on to animal
backline or applied as one spot concentrate on the animal back
Spot on s mainly used for grubs and lice
Eg: levimisole , broad spectrum anti helminthic activity
These formulation contains organiophosphorus insecticides or antihelminthic
dissolved in organic solvents as DMSO or aromatic hydrocarbons
The advantages of these formulations are
1. Elimination of risk of trauma and damage at injection site
2. No special skills are required for application
3. Sterile preparations are not necessary
4. Troublesome animals are dosed easily
5. Speed of treatment is quick

Dust bags
Cattle are treated with insecticide powders through use of a
device called a dust bag.
Dosing accomplished by animals brushing against the bag
as they walk beside or under it
This bag has an inner porous storage bag containing the
insecticide dust formulation
Forced use bags are hung in door ways or tree or pole
DIPS
For control of ectoparasites in economic animals, dipping is
an extensively used method
A dip formulation containing the drug is diluted in a large
dipping bath through which the animal is driven
This bath must be long, wide, and deep enough to cause
immersion of the animal
It must be non toxic to the animal but toxic to ectoparasites

Flea and tick collars

This dosage form is most familiar companion animals like dogs and
cats
There are two types of flea and tick collars

Vaporous
Powder producing collars

Both containing the insecticide and a plasticized solid thermoplastic

resin
Vaporous collar contains relatively high vapor pressure liquid
pesticide mixed throughout the collar
The pesticide is slowly released and fills the atmosphere adjacent to
the animal , that kills the pest but innocuous to the animal
The powder producing collar contain a solid solution of the drug in
the resin
Shortly after the collar is processed the particles migrate from within
the body of resin and form a coating of particles known as bloom

Ticks and fleas migrate through the neck area of the

animal as they contact the active pesticide is
released and kills the pest
Miscellaneous dosage forms
Pharmacists are responsible to compounding of ear
preparations for pets that are not commercially
available
Nebuliozers and aerosols are starting to be used in
small animals
Percutaneous patches are used in small animals
Eg; fentanyl

Over the counter drugs

Some OTC drugs used in small animals but in others
should not be used, Due to the differences in absorption
, receptor types, metabolism and other in digestive
system and dosage than in human
Anti inflammatories are used cautiously in dogs and
cats
Eg; aspirin

Acetaminophen and ibuprofen are two OTC drugs

highly toxic to small animals, cause blood dyscrasias
Anti histamines are widely used in small animals to
control allergies reactions
Eg: diphenhydramine

Anti diarrheal are used in dogs.

Creams and lotions may be used in animals , although
they can be licked off.

Containers
Mostly used plastics .
Having following problems
o Are less impervious to passage of
oxygen than glass
o Can not be sterilize by heat
o Deformed by some product
55

Labeling of veterinary drugs:

1.Name and address of veterinarian
2.Active ingredients
3.Date dispensed and expire date
4.Directions for use
5.Cautionary statements
6.Name and address of pharmacy /
pharmacist dispensing the
medication

Evaluation
1) Products All tests of a dosage form up to In vitro
evaluation including chemical assays and microbial
assays .
2) Target Animal
Tolerance Studies
1. General tolerance
2. Local tolerance
Tolerance testing of Injectables
Tolerance testing of products intended for Dermal
Applications
Tolerance testing of products intended for Oral
administration

57

1. Colour
2. Odour
3. Taste

Physical evaluation Tablets

1.
2.
3.
4.
5.
6.
7.

Disintegration time
Weight variation
Hardness and friability
Compaction
Particle size and crystal structure
Flowability of granules.
Moisture content
58

Physical evaluation of Oral

Liquids
1. Clarity of solution
2. PH
3. Viscosity
4. Solution time
Physical evaluation Suspensions and
Emulsions
1.
2.
3.
4.
5.

PH
Viscosity
Re-dispersion
Flocculation
Settling/Creaming

59

Physical evaluation of
Pastes
pH.

Viscosity.
Particle size Distribution.
Texture.

Physical evaluation of Gels

pH.
Viscosity.
Clarity.
Texture.
Swelling.

60

Physical evaluation of
Parenterals

Clarity.
pH.
Tonicity.
Syringeability.
Other Tests
Sterility.
Microbial Assay.
Pyrogen testing
61

Physical evaluation of
Implants
Locomotion.

Signs of pain.
infection, migration, or rejection

Physical evaluation of
Pellets

Angle of repose, hausners ratio,

Compressibility index,
Bulk density, true density and Granule density,
Flow rate,
Carrs Index.
In-vitro Dissolution studies
62

Controlling Authorities of Veterinary

Products

Animal Welfare and Animal Husbandry

Department, undertaking of the
Government of India.
Animal Health Institute (AHI).
US FDA ( Food & Drug Administration ).
Animal Drugs Availability Act 1996.
Animal Medicinal Drugs Clarification
Act 1968 (AMDOCA)
63

What drugs can be legally

marketed?
FDA approved products
NADA-new animal drug application
(pioneer)
ANADA-abbreviated NADA (generic)
CNADA-conditionally approved NADA
Indexed minor species products

64

VETERINARY DRUG APPROVAL

PROCEDURE
Like all human drugs, a new animal drug has to
beapproved by FDA before it is sold and
marketed to the public.
And like the human drug approval process, the new
animal drug approval process is complicated.
Before a new animal drug may receive FDA
approval, the drug sponsor must demonstrate
that the new animal drug product is safe and
effective when used as directed on the label.
Drug sponsors submit to FDA a New Animal
Drug Application (NADA) along with
supporting data, including all unexpected
side effects (adverse effects) associated with
the drug products use.
65

 The drug sponsor must show that it can

manufacture the drug product so that
the products composition is
consistent from batch to batch, that
the products active ingredients come
from reliable sources, and that it
follows good manufacturing practices
while making the product.
If the drug product is to be used in a foodproducing animal, residues in food
products (such as meat and milk) from
that animal must be shown to be safe for
human consumption.
66

U.S. REGULATORY REQUIREMENTS

FOR ANIMAL DRUGS
The center for veterinary medicine of
the Food and drug administration has
the responsibility for review and
approval of animal drugs
The mechanism for review and approval
of animal drugs is through the
submission of Form 356( NADA) new
animal drug application
Animal feeds containing drugs must also
be approved by submission of Form FD
1900, animal feed application

Before approval of new animal drug

application , the Center For
Veterinary Medicine (CVM) may
require a manufacturing facilities visit
called a preapproval inspection.
The GMP regulations are used as a
guide for this audit by inspectors
from the compliance division of FDA.
The requirements for laboratory data,
manufacturing equipment are same
for drugs used in humans or animals

Stepwise Regulatory
Requirements For Approval
Of Animal Drugs.

1. Pre-INAD (Investigational New

Animal Drug) Meetings.

Prior to opening an Investigational New

Animal Drug (INAD) file
Pre-INAD meetings for innovative products
Inform CVM about the product
Learn about the approval process
Pilot studies in laboratory research animals
(non-client owned animals)
Must comply with 21 CFR (Code of Federal
Regulation) 511.1(a)
69

2. INAD (Investigational
New Animal Drug)
Open the INAD
Provide as much product information
to CVM as possible
Product characterization
Can submit when you open the INAD
Request a meeting to discuss
product characterization and
development plan
70

INAD (Investigational New

Animal Drug)
Pilot studies in client owned animals
Must comply with 21 CFR 511.1(b)
INAD exemption allows shipment of
investigational drug in interstate commerce
Sponsor responsibilities under the INAD
Labeling, data collection, records, drug
accountability, animal disposition,
investigator qualifications

71

3. Pre-submission
Conference
After sufficient product
characterization
Work together to determine the
types of studies that will be used to
support safety, effectiveness, and
manufacturing

72

4. Protocols
May be submitted to CVM for review
Safety, effectiveness, manufacturing
CVM concurrence means we
fundamentally agree with the study
design

73

Major Technical Sections

Safety Target animal, special studies
Effectiveness Substantial evidence,
field study, conditions of use
Manufacturing Identity, strength,
quality, purity
Human Food Safety
Environmental

74

Minor Technical Sections

Labeling
All Other Information
FOI (Freedom of Information)

75

Administrative NADA
Administrative New Animal Drug
Application (NADA)
Administrative application submitted
after all technical sections are
completed
Completion of Administrative NADA
= FDA approved product
Non-administrative NADA
76