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The process validation of dosage form is one of the most important regulatory requirements for pharmaceutical industry. It shows the documented evidence about the quality of the product by validating the whole manufacturing process. According to USFDA, process validation is the collection and evaluation of data, from the design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality attributes. The aim of current study was to prospectively validate the manufacturing process of tablets of drug X and assure that product...

The objective of the present study was to develop an optimized gastroretentive floating drug delivery system of Olmesartan Medoxomil and investigate the effect of hydrophilic retardant on invitro release by using 32 full factorial design. Floating tablets of olmesartan medoxomil were prepared by direct compression method using effervescent technique by employing two different grades of HPMC. (HPMC K4M and HPMC K100M). Sodium bicarbonate was incorporated as gas generating agent. The concentration of HPMC K4M (X1) and concentration of HPMC K100M (X2) were selected as independent variables.The...

The first step in delivering the drug to the patient is to formulate a suitable delivery system that can maintain the minimum effective concentration of the drug in the body i.e the drug concentration should be within the therapeutic window. Conventional dosage forms generally deliver the drug immediately leading to a sudden rise and then decline in the drug concentration within the body. Delivering the right amount of drug at the required time is very important in effectively managing disease and minimizing side effects. Drugs with a short half-life need to be administered frequently more...