Dosage forms drug development

L. L. Ng, Reverse phase liquid chromatographic determination of dexamethasone acetate in cortisone acetate in bulk drug substances and dosage forms Method development, J. Assoc. Off. Anal. Chem., 70 829(1987). 

AN EXCIPIENT LIBRARY APPROACH TO ANALYTICAL DEVELOPMENT FOR LOW-DOSE, SOLID ORAL DOSAGE FORM DRUG PRODUCTS... 

Lee KJ, Kang A, Delfino JJ, et al. Evaluation of critical formulation factors in the development of a rapidly dispersing capto-pril oral dosage form. Drug Dev Ind Pharm 2003 29(9) 967-979. 

Since the ideal attributes of drug substances differ markedly for different dosage forms, properties appropriate to one dosage form may be inappropriate for another. For this reason, the drug substance attributes should suit the primary mode of delivery (i.e. oral, parenteral, inhalation, or other routes, if appropriate) and the dose (or dose range) required. If other dosage forms are developed, such as line extensions, at a future date, it may be necessary to counteract any adverse properties of the selected salt using suitable formulation techniques. 

Tang, B. Cheng, G. Gu, J.C. Xu, C.H. Development of solid self-emulsifying drug delivery systems Preparation techniques and dosage forms. Drug Discov. Today 2008,13 (13-14), 606-612. 

Since the development of the Spansule brand (Smith Kline Beech am) of coated beads and granules in the late 1960s, various dmg product technologies have been developed and patented to achieve extended durations of therapeutic effects. Each of these does so by various mechanisms of control of dmg release from adrninistered dosage forms. Each method has its advantages and disadvantages, a discussion of which is available in the pharmaceutical hterature (see Drug delivery systems) (21). 

For many drug delivery applications, the preferred method of delivery of the dosage form is by injection. For controlled release applications, the most frequently used approach to allow this method of administration is to prepare microspheres of the polymer containing the drug to be delivered. Several different techniques have been developed for the preparation of microspheres from polyanhydrides. 

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