Development and Formulation of Dosage

Prior to the last decade there have been few major review articles or other important literature published on the development of veterinary dosage forms. Of worthy note was the book Development and Formulation of Dosage Forms, edited by G.E. Hardee and J.D. Baggot, which has recently been republished with additional chapters as a second edition (3), several articles (4-11), and a special issue of the Journal of Controlled Release (12). 

Veterinary Drug Availability, Basis for Selection 3 of the Dosage Form, Formulation of Veterinary Dosage Forms, Protein/Peptide Veterinary Formulations, Formulation of Vaccines, Administration Devices and Techniques, Specification Development and Stability Assessment, Bioavailability Bioequivalence Assessments, Development and Formulation of Dosage Forms, Design of Preclinical Studies... 

Hardee GE, Baggott JD, eds. Development and Formulation of Dosage Forms. 2nd ed. New York Marcel Dekker, 1998. 

There are many similarities and differences in the anatomy and physiology of mammals, birds, and humans. It is outside the scope of this chapter to elaborate on the individual differences. For a brief review, refer to the third edition of Modern Pharmaceutics [9] and the second edition of Development and Formulation of Veterinary Dosage Forms [10]. 

J. D. Baggot and S. A. Brown, Basis for selection of the dosage form. Development and Formulation of Veterinary Dosage Forms, 2nd ed. (Gregory E. Hardee and J. Desmond Baggot, Eds.), Marcel Dekker, New York, 1998, pp. 9-27. 

Development and Formulation of Veterinary Dosage Forms Second Edition, Revised and Expanded, edited by Gregory E. Hardee and J. Desmond Baggot... 

Development and Formulation of Veterinary Dosage Forms Second Edition, Revised and... 

Foster, T.P. Protein/peptide veterinary formulations. In Development and Formulation of Veterinary Dosage Forms, 2nd Ed. Hardee, G.E., Baggot, J.D., Eds. Marcel Dekker, Inc. New York, 1998 231-282. 

For further discussion of bioequivalence the reader should refer to review of the 1993 Veterinary Drug Bioequivalence Workshop (Martinez Riviere, 1994), the review paper Veterinary drug bioequivalence determination (Toutain Koritz, 1997) and the chapter entitled Bioavailability bioequivalence assessments (Martinez Berson, 1998) in Development and Formulation of Veterinary Dosage Forms, 2nd edn. 

Klink, P.R., Ferguson, T.H. Magruder, J.A. (1998) Formulation of veterinary dosage forms. In Development and Formulation of Veterinary Dosage Forms, (eds G.E. Hardee J.D. Baggot), 2nd edn. pp. 145-229. Marcel Dekker, New York. 

The impact of formulation on protein absorption and disposition is also an important factor in the development and use of biologic molecules. Stability of the protein drug in subcutaneous or muscle tissues and absorption rates directly influence the overall response. Various physical and chemical approaches are used to stabilize proteins and other macromolecules as a part of optimizing dosage formulations. 

Preclinical drug development involves understanding of dosage, formulation, and route of administration, typically in animal models, so that safe and effective doses for human administration can be estimated. The drug development phase extends from prechnical assessment through clinical testing. 

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