Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability, and consistency of analytical results; it is an integral part of any good analytical practice. Analytical methods need to be validated or revalidated. Method validation has received considerable attention in the literature and from industrial committees and regulatory agencies. The proposed review included a strategy for the validation method, steps in method validation, and different parameters for method validation.

DOI: 10.31555/jpbs/2017/5/4/30-37

In recent years, significant interest has been shown in the development of novel bioadhesive dosage forms for mucosal delivery of drugs. A drug administered through the buccal mucosa enters directly to the systemic circulation, thereby minimizing the first-pass hepatic metabolism and adverse gastrointestinal effect. The objective of the project was to develop a stable and robust formulation of buccal tablet of the selected antifungal drug miconazole nitrate for the treatment of oral candidiasis. Oral candidiasis is an opportunistic infection of the mouth, highly prevalent in a specific group of patients including AIDS patients. Without treatment, the lesion may spread to the esophagus, causing invasive esophageal candidiasis, which is categorized as an AIDS-defining illness. Miconazole nitrate has a broad-spectrum of activity against most pathogenic fungi and Gram-positive bacteria. The drug has poor aqueous solubility. It has the potential to be used in the treatment of all forms of both mucosal and systemic candidiasis. The result of the project would provide a process that would provide stable formulation of buccal tablet. In this project, buccal tablet was prepared by direct compression. Among different trials with direct compression, the trial batch showed satisfactory in vitro drug release profile as compared to that of innovator for sustained release formulation.

DOI: 10.31555/jpbs/2017/5/4/38-43