Product variables, therapeutic efficacy and safety: Establishing a relationship between parenteral formulation and development
Chukwuma O Agubata
University of Nigeria, Nigeria
: J Pharm Drug Deliv Res
Abstract
The contents of a preparation and production processes can influence significantly the onset of a therapeutic effect, duration of action, absorption pattern, possibility of drug targeting and safety of the final product. Therefore, the development of a formulation for parenteral application must be integrated with its intended administration in a patient. Optimal selection of the drug, vehicle, additives, container, delivery device and production method is then required and the necessary match-making is performed through physical, chemical and pharmacological tests to obtain the desired final product that causes the expected therapeutic effect, safely. Considering the potential dangers associated with poor-quality parenterals, this review presents a guideline for quality assurance especially with respect to purity, content and stability. Pre-formulation studies are shown to include tests for contaminants, irritants, drug and excipient degradation, leaching from container, presence of microorganisms, pyrogens, toxicity, solvent activity and physicochemical properties of materials. Furthermore, formulation solutions to common production challenges are provided and these often require a good knowledge of the ingredients, formulation type, different production techniques, intended route of administration and in vivo distribution desired. The objectives of this review are to present the recent approaches in parenteral product development and to establish a useful relationship between product variables, therapeutic efficacy and safety in product optimization.
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