By Judy Senior, Michael L. Radomsky
Sustained-Release Injectable items specializes in the advance method for sustained-release types of gear and supply structures and management routes. From the reason and uncomplicated product improvement rules to regulatory concerns and the approval procedure, professional contributions handle nearly each element. they bring about jointly universal threads that observe to any sustained-release formula, reminiscent of scale-up, protection, biocompatibility, analytical demanding situations, and caliber coverage
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Extra resources for Sustained-Release Injectable Products
Although SC injections are relatively easier to administer, they are gener ally limited to nonirritating, hydrophilic drugs. 5 to 2 mL for SC injections, while volumes as high as 6 mL, perhaps even 10 mL, are possible with the IM route. 4 is a summary of the recommended usual adult dosage of unencapsulated drug substances and of drug sub stances in a lipid- or polymer-based drug product. The dosage for Amphotec®, AmBisome®, and Abelcet is greater than the maxi mum dosage for unencapsulated amphotericin B.
USA: Decision Resources, Inc. GEN. 1998. Genetic Engineering News (June 15). Kadir, R, J. Zuidema, and D. J. A. Crommelin. 1992. Liposomes as drug delivery systems for intramuscular and subcutaneous injections. In Pharmaceutical particulate carriers in medical applications edited by A. Rolland. New York: Marcel Dekker, Inc. MedAdNews. 1998. The Magazine of Pharmaceutical Business and Marketing (August). Engel Publishing Partners, West Trenton, New Jersey. PDR. 1998. Physicians desk reference, 52nd ed.
Formulations by Encapsulation 33 the encapsulated drug substance in the aqueous core, and the choice of appropriate buffer salts for maintaining isotonicity and pH are critical in the development of a lipid-based sustained-release injectable product. Lipid hydrolysis can be prevented if a solid dosage form is chosen. However, formation of a solid dosage form by lyophilization of a liposome frequently results in a loss of the structural integrity of the liposomal struc ture and a release of the encapsulated hydrophilic drug sub stance.