Physicochemical Principles of Controlled Release Veterinary Pharmaceuticals
This chapter describes the basic physical and chemical properties relevant to drug formulation. It encompasses discussion on the active pharmaceutical ingredient, excipients, and final product and it highlights the importance of physical and chemical att
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Physicochemical Principles of Controlled Release Veterinary Pharmaceuticals John G. Fletcher, Michael J. Rathbone, and Raid G. Alany
Abstract This chapter describes the basic physical and chemical properties relevant to drug formulation. It encompasses discussion on the active pharmaceutical ingredient, excipients, and final product and it highlights the importance of physical and chemical attributes of compounds in the selection of ingredients; development of dosage forms; and its significance in active and product assessment, characterization, performance, and quality.
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Introduction
Knowledge of the physicochemical principles of pharmacy is the cornerstone of product research and development. An understanding of the physical and chemical attributes of the active pharmaceutical ingredient, excipients, processing method, and final product underpins the rational selection of ingredients and excipients, facilitates choice of manufacturing parameters, and underpins quality control tests.
J.G. Fletcher (*) School of Pharmacy and Chemistry, Kingston University, Kingston upon Thames, UK e-mail: j.fl[email protected] M.J. Rathbone Division of Pharmacy, International Medical University, Kuala Lumpur, Malaysia R.G. Alany School of Pharmacy and Chemistry, Kingston University, Kingston upon Thames, UK M.J. Rathbone and A. McDowell (eds.), Long Acting Animal Health Drug Products: Fundamentals and Applications, Advances in Delivery Science and Technology, DOI 10.1007/978-1-4614-4439-8_5, © Controlled Release Society 2013
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The physicochemical properties of a drug affect its ability to be formulated, dictate selection of excipients, influence the rational selection of incoming raw material tests to assure its suitability for use in the final product, and provide the rationale for its assessment and evaluation during development and post manufacture (i.e., the product quality attributes). The physicochemical properties of compounds play a role throughout the entire product development process from pre-formulation to final product quality control. The basic physicochemical principles that underpin veterinary product development are the same as those applied to human product research and development. The difference resides in the outcome of the application of that science. Human and small animal (e.g., cats and dogs) product research and development tends to result in products that are similar in size, shape, and drug load. Tablets, capsules, small implants, microparticles, in situ forming gels, solutions, and suspensions are commonly found dosage forms in both these groups. In contrast, products for farmed animals (e.g., cattle, sheep, pigs) are very large, exhibit a variety of shapes not encountered in their human or small animal counterparts, and contain high amounts of active ingredient. In addition, controlled release products for farmed animals often contain drugs that do not possess the same “ideal characteristics” for selection into a controlled release product as those commonly cited in h
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