Veterinary Dosage Forms

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1 Tuesday, June 21, 2011 1 VETERINARY FORMULATIONS Presented by: Bhadakwade Niranjan S. ( M. Pharm. IInd Sem , Pharmaceutics) SND college of Pharmacy Babhulgaon A UNIVERSITY SEMINAR ON

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Tuesday, June 21, 2011 2 CONTENTS Introduction Routes of Administration & Dosage Forms Formulation of Premix Drinking Water Medication Compounding Options by Oral Route Current Oral Technologies Evaluation Labeling of Pharmacist-compounded Veterinary Drugs Challenges 2020 Vision for Veterinary Medicines Marketed Formulations Conclusion References

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Tuesday, June 21, 2011 3 Introduction Animals provide us with Companionship, Recreation, Food, and Manual Labor. Just like humans these animals receive medicines to keep them healthy. Drugs have been compounded for veterinary practice for many years but, Regulations and Compliance Policy Guidelines (CPGs) should be recognized. A CPG issued in July 2003 listed the current Food and Drug Administration (FDA) limitations on compounding for veterinary medicine. However, veterinarians and pharmacists must be aware of potential incompatibilities and practices that may interfere with the drug’s stability, purity, and/or potency.

Animal population figures ::

4 Animal population figures : Tuesday, June 21, 2011 4 Animal Population (millions) % Household Dogs 53 37 Cats 59 31 Cattle 98 - Swine 56 - Sheep 07 - Birds 12.6 10 Horse 04 02 Animal Veterinary Medical Associations 2007 survey

U.S. Animal Health Market by Dosage form (based on 2007 sales):

5 U.S. Animal Health Market by Dosage form (based on 2007 sales) Tuesday, June 21, 2011 5 Dosage form % of sale Feed premix Injectables Oral tablets, Capsule, Bolus Oral liquids, Powders Topical Implants Paste, gels Intramammary 35 33 09 08 05 04 03 02

Why people consider Veterinary Medicine as an Career ?:

6 Why people consider Veterinary Medicine as an Career ? Compassion and respect for animals To save the animal Interest in science and medical research Skills and patience necessary for a service profession Desire to improve the welfare of both animals and humans Low investment and higher profit Tuesday, June 21, 2011 6

Advantages of Veterinary Medicine::

7 Advantages of Veterinary Medicine: Opportunity Economics Research Zoonosis Tuesday, June 21, 2011 7

Controlling Authorities of Veterinary Products::

8 Controlling Authorities of Veterinary Products: Animal Welfare and Animal Husbandry Department, undertaking by Government of India. Animal Health Institute (AHI) US FDA ( Food & Drug Administration ) Animal Drugs Availability Act 1996 Animal Medicinal Drugs Clarification Act 1968 (AMDOCA) Tuesday, June 21, 2011 8

Route of Administration & Dosage Forms::

9 Route of Administration & Dosage Forms: Oral dosage forms Solutions, Emulsion Suspensions, Paste & Gels Capsules and Tablets Powders & Granules Modified Release product Feed/Water Parenteral administration Intravenous Intramuscular Subcutaneous Tuesday, June 21, 2011 9

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10 Parenteral dosage forms Aqueous, organic and oily solutions Emulsions Suspensions Implants Implantable infusion device Subdermal implants Intramammary administration Topical application Pour-on / Spot-on applications Dust bags Dips Flea & Tick Collars Tuesday, June 21, 2011 10

Factors involved in deciding route of administration::

11 Factors involved in deciding route of administration: Concentration of drug needed ? Where in the body is the drug needed ? How fast is the action needed ? For how long is the action needed ? Any problem with prefered route ? Safety of the treatment ? Cost of the treatment ? Tuesday, June 21, 2011 11

Why Oral route ?:

12 Why Oral route ? Improved clinical effectiveness. The relative efficiency of reduced dosing regimens (i.e. improved animal patient compliance) Relative savings in animal patient handling and medical care Consumer convenience and compliance are major drivers for companion animals. Tuesday, June 21, 2011 12

Formulation via Feed makes Ideal route for Prophylactic drug treatment::

13 Formulation via Feed makes Ideal route for Prophylactic drug treatment: Pellets - diameter from 3/3 to 3/4 inch Crumbles - small diameter than the pellets and they generally added in regular feed Briquettes - designed as individual drug treatment for large animal e.g. estrus regular medication Liquid feed supplement Tuesday, June 21, 2011 13

Formulating the Premix::

14 Formulating the Premix: Preformulation knowledge Premix made with essential pure drug Premix made with fermentation product Premix is the dilution of pure component prepared by addition of carrier, diluents, or absorbent. Carrier: Rice hulls, Wheat middling, Corn germ meals Diluents: Lime stone, Kaolin, Corn cob flour, Sodium sulfate Adsorbents: Vermiculite, Fullers earth, Corn cob fractions, Clay. Tuesday, June 21, 2011 14

Factors need to be consider in formulation of premix::

15 Factors need to be consider in formulation of premix: Drug concentration in premix Drug concentration in final feed Moisture content of drug & carrier Electrostatic charges pH extremes Flow Normal standard of premix usage in feed is, 1 part medicated premix : 1999 parts of feed. Tuesday, June 21, 2011 15

Drinking Water Medication :

16 Drinking Water Medication Common form of medicating animals for herd or flock health. Dry powders for reconstitution, concentrated solutions can be given in drinking water For sick and unhealthy animals Drug concentration in water is half of that in feed as animals drink twice as much water as they consume feed Automatic metering devices for treating large number of animals Common dilution in U.S.A. is 1 fluid ounce of Stock solution to 127 ounces of water Tablet or granules hardness, buffer capacity, pH and total dissolved solids play role in solubility of drug and availability of drug If solvent other than water then, possibility of precipitation or recrystallization of drug Tuesday, June 21, 2011 16

Drinking Water Medication :

17 Drinking Water Medication Tuesday, June 21, 2011 17

Flavors that animals prefer include::

18 Flavors that animals prefer include: Dogs like Beef, Chicken, Cheddar Cheese, Molasses, Peanut Butter, Liver, Raspberry, Strawberry Cats like Tuna, Chicken, Beef, Cheddar Cheese, Peanut Butter, Liver, Butterscotch. Birds like Grape, Mandarin Orange, Tutti-Frutti, Molasses, Pina Colada. Horses like Apple, Creamy Caramel, Molasses, Licorice, Cherry. Rabbits like Banana Ferrets like Bubblegum, Molasses. Gerbils like Mandarin Orange, Tutti-frutti. Tuesday, June 21, 2011 18

Compounding Options by Oral Route::

19 Compounding Options by Oral Route: Suspensions/Solutions Chewable Tablets Capsules Concentrated Oils Disintegrating Oral Tablets Tuesday, June 21, 2011 19

Current Oral Technologies::

20 Current Oral Technologies: Matrix system Reservoir system Osmotic system Ruminal therapeutic system (RUTS Push Melt™ Technology) Tuesday, June 21, 2011 20

Osmotic system (Ruminal Therapeutic System: RUTS Push Melt™)::

21 Osmotic system (Ruminal Therapeutic System: RUTS Push Melt™): Tuesday, June 21, 2011 21 Cross-section of Ruminal therapeutic system (RUTS) Push-Melt™ system.

Osmotic / Hybrid systems:

22 Osmotic / Hybrid systems Pulsincap formulation Gastric Retention systems Floating systems Swelling system Bioadhesive systems Modified Shape systems High Density formulations Tuesday, June 21, 2011 22

Dose Dispensers:

23 Dose Dispensers Variety of dosage designs Diversity of animal and birds species Drug / Dosage delivery Purpose For Specific Devices Effectivity Low cost efficient treatment Fast results Safety Tuesday, June 21, 2011 23

Types of Devices:

24 Oral Devices Balling gun Esophageal Delivery Devices Syringes Tubes Drench syringes Liquid drench gun Paste Dispenser Water Medication Metering Devices Miscellaneous Devices For Oral Route Dust Bags Tuesday, June 21, 2011 24 Types of Devices

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Balling Gun Liquid Drench Gun Tuesday, June 21, 2011 25

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Pistol Grip Pro Shot Syringe 582 Glass Tube Injector SMC G1321 Tuesday, June 21, 2011 26

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27 Continuous Drencher KD 114 910 Plastic Steel Syringe KD 302 102 Tuesday, June 21, 2011

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28 Weighing Instrument Veterinary Immobilizer Tuesday, June 21, 2011

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29 Tuesday, June 21, 2011 29 Dust Bags


Evaluation I) Products – All tests of an dosage form upto In vitro evaluation II) Target Animal – Tolerance Studies General tolerance Local tolerance Tolerance testing of Injectables Tolerance testing of products intended for Dermal Applications Tolerance testing of products intended for Oral administration Tuesday, June 21, 2011 30 Bioequivalence Studies C max T max AUC

Labeling of Pharmacist-compounded Veterinary Drugs:

Labeling of Pharmacist-compounded Veterinary Drugs It must include: Name & Address of the Veternarian Active Ingredient(s) Date dispensed & Expiration date Directions for Use Cautionary Statements Withdrawal times if animal is to be slaughtered for human consumption or produces eggs or milk Name & Address of Pharmacy/Pharmacist dispensing the medication Tuesday, June 21, 2011 31


32 Challenges: Practice is very low. Distinguishing feature contribute variation in handling drugs. Residue in meat, milk, or eggs. Chloramphenicol produces plastic anemia in animals. Dimetridazole (Interohepatitis) residue in animal tissue, U.S. approved, revoked in 1997. ADI & MRLs for many drugs is not yet known. Strict controlling authority regulation. Tuesday, June 21, 2011 32

2020 Vision for Veterinary Medicines:

2020 Vision for Veterinary Medicines Short Term Crossover of medicines from - Human health - Crop protection Development cost & Product price drives off-shoring Outsourcing delivers smaller value product enhancements Mid Term Generics across all therapeutic classes Pre-emptive disease prevention Innovators in biologics & vaccines Owners struggle with pet medicine High costs for Pet chronic therapy and Insurance. Long Term Extensive vaccination Genetics for problem free pets & livestock Replacement Pet copies Stem cells for mass food & tissue production Insurance company approved low risk pets 2012 2020 Tuesday, June 21, 2011 33

Marketed formulations::

34 Marketed formulations: Tuesday, June 21, 2011 34 Benzyl Penicillin Inj.(DPI) Melogin Plus (Bolus) Calcimal – CBG (LVPs) Fungisept (Ointment) Flucol (Ectoparasite) Pashu Bhog (Feed Suppl.) Courtesy to


Conclusion Animal drug dosage forms have their own requirements & characteristics based on the unique aspects of mammal & avian physiology. Many drugs used in veterinary medicine are not used in human medicine and therefore pharmacists may not know their attributes. The pharmacist who desires to practice in this area should undertake self-study to learn the chemical, biochemical (metabolism), pharmacological (mechanisms), therapeutic (clinical outcomes), and pharmaceutic (dosage forms) and pharmacokinetic characteristics of these compounds. Tuesday, June 21, 2011 35


36 References: Veterinary Pharmaceutical Dosage Forms; In Modern Pharmaceutics; Edited by A. T. Florence & J. Siepmann; Informa Healthcare INC.; 5 th - edition; Vol- 189; pp – 293. Veterinary Dosage Forms; In Encyclopedia of Pharmaceutical Technology; Edited by J. Swarbrick & J. C. Boylan; Marcel Dekker INC.; 2 nd – edition; Vol- 3; pp – 2932. The Pharmacist & Veterinary Pharmaceutical Dosage Forms; In Modern Pharmaceutics; Edited by G. S. Banker & C. T. Rhodes; Marcel Dekker INC.; 4 th – edition; Vol- 121; pp – 725. Tuesday, June 21, 2011 36

Slide 37:

37 Tuesday, June 21, 2011 37 Thank YOU!!! SUGGETIONS & COMMENTS…

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