This article would be provided different dosage forms are used especially for veterinary and also provided the importance of veterinarian.It can also provided the European guidelines for medicinal products that used for Human and Veterinary. For discovering various animal diseases, new technological devices as well as treatments are also available in this article.
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1. VETERINARY DRUG DELIVERY
SYSTEM
GUIDED BY: PREPARED BY:
DR.J.M.PATEL SAGAR Y.
GODA
B.K.M.G.P.C. M.PHARM SEM -1
RAJKOT. ROLL NO -03
EN NO
-162120808005
B.K.MODY GOVERNMENT PHARMACY COLLEGE
2. CONTENTS
INTRODUCTION
ADVANTAGES AND DISADVANTAGES OF VDDS
CLASSIFICATION OF DOSAGE FORMS
MANUFACTURING PROCESS LAYOUT
GMP GUIDELINES FOR VETERINARY
i. DOCUMENTATION
ii. PREMISES AND EQUIPMENTS
iii. PRODUCTION
iv. QUALITY CONTROL
v. PHARMACEUTICAL QUALITY SYSTEM
VETERINARY DOSAGE FORMS
PACKAGING AND LABELLING
EVALUATION PARAMETERS
ACCEPTED PRODUCTS
MARKETED PREPARATIONS
NEWER TECHNOLOGIES IN VDDS
CONCLUSION
REFERENCES
2
3. INTRODUCTION
• Word veterinary is derive from the Latin word Veterinae meaning working
animals.
• The first veterinarian was Thomas Browne. Claude Bourgelate established
the first veterinary college founded in Lyon, France in 1762.
• Veterinary medicine is the branch of medicine that deals with the
prevention, diagnosis and treatment of disease, disorder and injury in non-
human animals.
• Veterinarian is also called as Vet, Veterinary Physician or Veterinary
Surgeon.
• “Veterinarian is a professional who practices veterinary medicine by
treating diseases, disorder, and injury in animal.”
3
4. ADVANTAGES AND DISADVANTAGES OF VARIOUS ROUTES
IN VDDS
Route Advantages Disadvantages
Oral • Easy • Preferred by patients • “Slow-release”
preparations may be available to extend duration
of action • Drugs can be formulated in such a way
as to protect them from digestive enzymes, acid,
etc.
• Unsuitable in patients who are uncooperative, strictly “nil
by mouth”, are vomiting profusely or have ileus • Most
orally administered drugs are absorbed slowly •
Unpredictable absorption due to degradation by stomach
acid and enzymes
Rectal • Good absorption – the haemorrhoidal veins drain
directly into the inferior vena cava, avoiding
hepatic first pass metabolism
• May not be suitable after rectal or anal surgery • Some
patients dislike suppositories
Subcutaneous or • Good absorption, especially for drugs with a low • Absorption may still be unpredictable if peripheries are
intramuscular oral bioavailability • Onset is more rapid than the
above routes • Depending on formulation can
have very long duration of action, e.g. depot
antipsychotics and contraceptives
poorly perfused • Injections hurt, cause bruises and
frighten children and needle phobics
Intravenous • Dependable and reproducible effects • Entire
administered dose reaches the systemic
circulation immediately -the dose can be
accurately titrated against response
• Requires a functioning cannula • More expensive and
labour intensive than other routes. • Cannulation is
distressing to some patients, especially children •
Cannulae are prone to infection • IV injection of drugs may
cause local reactions
Topical • Easy • Non-invasive • High levels of patient
satisfaction
• Most drugs have a high molecular weight and are poorly
lipid soluble, so are not absorbed via skin or mucous
membranes • Very slow absorption
Inhaled • Very rapid absorption due to the huge surface
area of the respiratory endothelium •
Bronchodilators and inhaled steroids can be
targeted to lungs with low levels of systemic
absorption
• Bioavailability depends on patient’s inhaler technique and
the size of drug particles generated by the delivery
technique
4
8. GMP GUIDELINES FOR
VETERINARY
I. DOCUMENTATION
II.PREMISES AND EQUIPMENTS
III.PRODUCTION
IV.QUALITY CONTROL
V.PHARMACEUTICAL QUALITY
SYSTEM
8
9. I. DOCUMENTATION
• Principle
• Required GMP Documentation
• Generation and Control of Documentation
• Good Documentation Practices
• Retention of Documents
• Specifications
• Manufacturing Formula and Processing
Instructions
• Procedures and records
9
10. II. PREMISES AND EQUIPMENTS
PREMISES:-
• GENERAL
• PRODUCTION AREA
• STORAGE AREA
• QUALITY CONTROL AREA
• ANCILLARY AREA
EQUIPMENTS:-
10
11. III. PRODUCTION
PRINCIPLE:
• Production operations must follow clearly defined procedures;
they must comply with the principles of Good Manufacturing
Practice in order to obtain products of the requisite quality and
be in accordance with the relevant manufacturing and
marketing authorizations.
GENERAL:
PREVENTION OF CROSS CONTAMINATION:
STARTING MATERIALS & EXCIPIENTS:
PROCESSING OPERATIONS:
PACKAGING OPERATIONS:
FINISHED PRODUCT:
11
12. IV. QUALITY CONTROL
PRINCIPLE:
• Quality Control is concerned with sampling, specifications and
testing as well as the organisation, documentation and release
procedures which ensure that the necessary and relevant tests
are carried out, and that materials are not released for use, nor
products released for sale or supply, until their quality has
been judged satisfactory.
GENERAL:
SAMPLING:
TESTING:
12
13. V. PHARMACEUTICAL QUALITY SYSTEM
• The attainment of this quality objective is the responsibility of
senior management and requires the participation and
commitment by staff in many different departments and at all
levels within the company, by the company’s suppliers and by
its distributors. To achieve this quality objective reliably there
must be a comprehensively designed and correctly
implemented Pharmaceutical Quality System incorporating
Good Manufacturing Practice and Quality Risk Management.
• The basic concepts of Quality Management, Good
Manufacturing Practice and Quality Risk Management are
inter-related. They are described here in order to emphasize
their relationships and their fundamental importance to the
production and control of medicinal products.
13
14. VETERINARY DOSAGE FORMS
• Just like the humans, animals also require the
medicine to cure the physical or the mental
disability .There are various routes through
which the drug or dosage form are
administered. Veterinary dosage forms are
essentially pharmaceutical drugs product in the
form in which they are marketed for use
typically involve a mixture of active drug and
non-drug component (excipients).
14
15. Types of dosage forms
Tablets and Boluses
Capsules
Feed Additives
Drinking Water Medication
Parenteral Dosage forms
Oral Pastes and Gel
Drenches and Tubing Products
Topical Dosage Forms
15
16. TableTs and boluses
• Solid dosage form like compressed tablet is
most common in case of humans. They are
less popular in animals because
administration is uncertain.
• Why the administration is uncertain….???
16
17. ConTinued…
• “It is uncertain because one cannot be sure
the tablet is swallowed, spit out, or drop from
mouth after administration.”
• Typically the tablet are chewed by the
animals and due to undesirable taste of
certain drug the animals can spit out that
tablet from the mouth, this will result in loss
of dosage form. To avoid this the flavoring
agents, sweeteners can be added to the
formulation.
17
18. ConTinued…
• Drugs are given on the basis of body weight of the
animal or body surface area of animal.
• Example-
15g of drug for each 150 kg body weight
75g of drug for each 750 kg body weight of cow or
horses.
• A special tablet called a “bolus” is commonly used
these large dosage. A bolus is nothing more than a
very large tablet , which can range from
• 3 to 16 g or more.
18
19. Capsules
• A typical gelatin capsules used for humans
can be used also in veterinary medicines.
Capsules are mainly used for dog and cat.
There are some vitamin and mineral
supplement capsule formulated for cattle.
19
21. feed addiTives
• Feed additive are preparations used in
veterinary medicine to deliver the API via the
water or food given to the animals. They may
be either solid or liquid and sometimes also
called as premix.
21
23. Type A – Medicated Articles
Contain One or more API
Sold to licensed feed mill
Product are diluted with water or food and then
consumed
23
24. Type B – Medicated feed
Contain Type A medicated articles
With this it contain nutrients
(not less than 25% of total weight)
Product are diluted with water or food
and then consumed
24
25. Type C – medicated feed
This contains compressed or molded
blocks
It also contains the nutrients
Product are diluted with water or food
and then consumed
25
26. drinking WaTer mediCaTion
• Drinking Water Medications are mainly
categorized into two classes
Dry Powder:
• Dry powder reconstituted into liquid
concentrate and then mix into drinking
water.
Concentrated Solution:
• Dispensed directly into drinking water in
medicinal proportion.
26
28. injeCTables
Solution:
• Mixture of two or more component to form a single
homogenous phase
Suspension:
• Insoluble solid particles dispersed in liquid medium
Emulsion:
• Heterogeneous dispersion of two immiscible liquid in
another
Dry powder:
• Reconstituted as a solution or suspension immediately prior
to injection
28
29. Intra-mammary InfusIon
• Intra mammary infusion product are available for
lactating and non-lactating cow. Lactating cow intra
mammary infusion should demonstrate fast and
even distribution of the drug and a low degree of
binding to under tissue. These properties result in
lower concentration of drug residue in milk.
29
30. Intra-vagInal DelIvery system
• Intra-vaginal system includes polyurethane sponges
containing synthetic progestin; silicon based insert
containing naturally occurring hormone
progesterone. Electronically controlled inserts
capable of delivering multi drug at a predefined
time, either pulsed or continuous fashion and a
biodegradable insert called PCL intra-vaginal
insert.
Polyurethane sponge
containing progestin
30
31. Implants
• The majority of implants used in veterinary
medicines are compressed tablet or dispersed
matrix system in which the drug is uniformly
dispersed in non-degradable polymer.
31
32. oral pastes anD gel
• Pastes and gels are semi-solid masses that
can be administered from a flexible tube,
syringe, package or other specialized dosing
devices. Three types of vehicles are used to
formulate a paste or gel.
Oil base
Organic
base
Aqueous
base
32
33. Oil Base:
• Oil base consist of vegetable oil thickened with agents such
as aluminum monosterate, colloidal silica and xanthan gum.
Lubricant property make the formulation less adhesive then
water base.
Organic base:
• Glycerin, Propylene glycol, Polyethylene glycol with
corboxyvinyl polymer provide the organic base.
Aqueous Base:
• An aqueous base is less expensive vehicle and less toxic. A
solution of drug in water or water and co solvent is made.
Glycerin, glycols, natural and synthetic gums increases the
viscosity, cohesiveness, plasticity. Water separation is the
most common problem with aqueous base to overcome this
the absorbing material like ,microcrystalline cellulose,
colloidal silicon dioxide, starch etc can be added.
33
34. Drenches anD tubIng proDucts
• Administration of the drug to animal by
pouring the liquid medication down an
animal’s throat is called “Drenching”.
Drenches are dispensed via the syringe or
drenching gun .
Anti parasite
medication
Ivermectin Drench 34
36. tubIng proDucts
• Horses are administered certain medication
by running the lubricated tube up through
the nostrils and down into the stomach. A
funnel is attached to the tube is held above
the horse head and the liquid medication is
poured down the tube. This is called
“tubing”.
36
38. pore – on / spot - on
applIcatIon
• These products are generally used against
ectoparasites. They act as neurotoxins. In
cattle the spot-on are mainly used to control
of grabs and lice. Hence they have broad-
spectrum antihelmintic activity. These
formulations contain organophosphorous
insecticides or antihelmintic dissolved in
organic solvent.
38
39. Dust bags
• Cattles are treated with insecticides powder
through use of device called dust bag. Dosing
is accomplished by the animal brushing
against the bag. The bag has inner porous
storage bag containing the insecticide dust
formulation.
39
40. DIps
• Dips are use for controlling the ectoparasites
in economic animals. Dip formulation
contains the drug diluted in a large bath.
This bath must be long, wide, and deep
enough to deep the animal.
40
41. pacKagIng anD labellIng
1. FOR FEED ADDITIVES:
• Type A medicated articles or type B medicated feeds
include special labeling to indicate that they should be
used in the manufacture of animal feeds or added to
the drinking water.
• The labels indicate that they are not to be fed directly to
animals. Also included is a statement indicating ‘‘Not for
Human Use’’.
2. FOR DIP CONCENTRATES:
• the name(s) and proportion(s) of medicament(s)
• the name and proportion of any added antimicrobial
preservative
• any special precautions to be taken for use of the
preparation
• the storage conditions
41
42. contInue…
3. FOR PRIMIXES:
• the strength in terms of the amount of active
ingredient(s) as a percentage
• the category of animal for which the premix is intended
to be used
• any special precautions to be taken for use of the premix
• the storage conditions
4. FOR ORAL POWDERS:
• for single dose containers, the name and quantity of
active medicament(s) per container
• for multiple dose containers, the name and quantity of
active medicament(s) by weight
• the directions for use of the preparation
42
43. CONTINUE…
5. FOR INFLAMATORY INFUSIONS:
• the strength in terms of the weight or the number of
Units of activity of the active ingredient(s)
• for Intramammary Infusions (Non-lactating or Dry
Cow/Buffalo), that the preparation is not intended for use
in lactating animals.
• in multiple dose containers, the name of any added
antimicrobial preservative.
43
44. EVALUATION PARAMETERS
1 Products – All tests of a dosage form up to In vitro evaluation
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
• Bioequivalence Studies
I. Cmax
II. Tmax
III. AUC
44
45. ACCEPTED PRODUCTS
Name of
Product as
Marketed
Type of
Product
Claim Company Species Market Year Seal
Awarded
Prescription Diet®
Canine t/d®:
Original Bites
Diet Plaque & Tartar
Hill’s Pet
Nutrition Inc.
Dog Veterinarian 1998
Prescription Diet®
Feline t/d®
Diet Plaque & Tartar
Hill’s Pet
Nutrition Inc.
Cat Veterinarian 2001
Eukanuba® Adult
Maintenance Diet
for Dogs
Diet Tartar Iams Company Dog Consumer 2003
Canine Greenies ®
-all sizes
Edible Treat Plaque &Tartar
The
Nutro/Greenies
Company
Dog
Consumer &
Veterinarian
2007
Dog::ESSENTIAL
™ healthymouth™
anti-plaque gel
Oral gel Plaque
HealthyMouth
LLC.
Dog
Consumer &
Veterinarian
2011
SANOS Dental
Sealant
Dental Sealant Plaque & Tartar AllAccem, Inc. Dog Veterinarian 2011
45
48. NEWER TECHNOLOGIES IN VDDS
MAGNETIC RESONANCE IMAGING (MRI):
• Vets are now using the imaging technology to look into
the brains of pets and other animals.
• MRIs are also very effective for getting scans of
orthopedic and soft tissue structures prior to surgery.
• By being able to see what is going on inside the animal
before going in for surgery.
ULTRASOUNDS:
• Ultrasound imaging technology is much cheaper and has
the potential to become universally adopted by vets.
• The ultrasound is the preferred method of creating
images of fetuses as they develop inside the mother.
• Ultrasounds have the advantage of not requiring
anesthesia and being relatively cheap to perform. 48
49. CONTINUE…
LAPAROSCOPY:
• Laparoscopic procedures use a small camera and light
source that can be inserted into the abdominal or
thoracic cavity to see inside the body.
• These procedures are less invasive than most surgical
operations and produce a clear image.
• It was first used in 2011 to remove the gallbladder from
moon bears.
3-D PRINTING:
• To create animal bone models from the information
gathered from computed tomography scans(CT-SCAN).
• Doing so enables vets and surgeons to have a solid
grasp of a animals internal bone or muscle structure
before going in to operate.
• The models help educate pet owners about the anatomy
and physiology of their pets.
49
50. CONCLUSION
• Animal drug dosage forms have their own
requirements and characteristic based on the
unique aspect of mammal and avian physiology.
Many drug used in veterinary medicine are not used
in human medicine and therefore pharmacists may
not know their attributes.
• Veterinary pharmaceuticals serve an important role
in preserving and restoring animal health, thereby
also enhancing human wellbeing.
50
51. REFERENCES
• Shradha Tiwari, Sachin Mitkare, Pallavi Bhangale; Veterinary Dosage
Forms: International Journal of Applied Pharmaceutics, ISSN 0975-7058,
Vol-6, Issue 1,2014. P.20-29
• Ramteke KH, Joshi SA, Dighe PA and Kharat AR; Veterinary
Pharmaceutical Dosage Forms: A Technical Note, Austin Publishing
Group, Austin Therapeutics, ISSN-2472-3673,Vol-1,Issue 1,2014. P.1-10
• Europian Commission Health and Directorate General,
Brussels,Ares(2014)968036- 28/03/2014
• Product List Updated www.VOHC.org
• Europian Commission Health and Directorate General,
Brussels,Ares(2015)283695- 23/01/2015
• Europian Commission Health and Directorate General,
Brussels,Ares(2015)283689- 23/01/2015
• Europian Commission Health and Directorate General,
Brussels,SANCO/C8/AM/sl/Ares(2010)1064587.
• www.picscheme.org under section of publication
51
52. REFERENCES
• Europian Commission Health and Directorate General,
Brussels,SANCO/C8/AM/sl/ddg1.d.6(2012)860362.
• Veterinary Dosage Forms; In Encyclopedia of Pharmaceutical Technology;
Edited by J. Swarbrick and J. Boylan; Marcel Dekker INC; second edition;
vol-3; pp- 2932.
• http://carrington.edu/blog/veterinary/newest-advances-veterinary-
technology/
1.“New Advances in Technology for Pets,” Veterinary Medicine and
Biomedical Sciences, Texas A&M
University, http://vetmed.tamu.edu/news/pet-talk/new-advances-in-
technology-for-pets#.U3Z9lPldWRN
2.“New technology could help reduce bone fractures in horses,” James M
Lewis,
dvm360, http://veterinarynews.dvm360.com/dvm/Veterinary+Equine/New
-technology-could-help-reduce-bone-fractures-
in/ArticleStandard/Article/detail/529567
3.“Pet Talk: Advances in technology affect veterinary medicine,” Sarah
Netherton, The News-Gazette, http://www.news-gazette.com/living/2014-
05-04/pet-talk-advances-technology-affect-veterinary-medicine.html
52
53. REFERENCES
4.“Developments in New Animal Technologies Show Rapid Advancement,”
Suzanne Sechen, Ph.D., FDA
Vetrenarian Newsletter, http://www.fda.gov/animalveterinary/newsevents/f
daveterinariannewsletter/ucm085008.htm
53