الفهرس | Only 14 pages are availabe for public view |
Abstract A polymer is a large molecule made up of many small repeating units called monomers. They are considered as an important component of pharmaceutical dosage form. The use of polymers in pharmaceutical preparations was developed early in the 20th century, corresponding to a rising need for the minimization of toxic side-effects and for the lifecycle management of drugs. It is believed that the physicochemical properties of the polymers affect the formulation and clinical performance of the pharmaceutical dosage forms. Polymers such as polymethacrylates, carbomers, hydrocolloids and cellulose ethers are commonly used in the formulation of oral drug delivery system Cellulose ethers are considered to be the most important class of ethers used in pharmaceutical formulations. This class of polymers includes: methylcellulose, ethylcellulose, hydroxypropylcellulose, carboxymethylcellulose and hydroxypropylmethylcellulose (HPMC). HPMC is identified as the most popular cellulosic polymer in matrix applications due to its safety, availability, compatibility, global compliance and ease of processing. Drug release from modified release system is influenced by number of variables which could be divided into drug-related variables, polymer-related variables and formulation and method of manufacturing-related variables. The drug related variables include drug solubility, content, molecular weight, particle size and stability; while the polymer related variables include polymer type, content, and degree of substitution, molecular weight and source. Variables such as system geometry (shape and size), method of preparation, physical characteristics of the dosage form (crushing strength), and the nature of excipients/additives (fillers, binders, surfactants, and lubricants) are examples of formulation and method of manufacturing-related variables. These variables affect the release pattern, and therefore can be manipulated to achieve the desirable release kinetics. The aim of the thesis is to investigate the influence of process variables, polymer properties, polymer source as well as the influence of additives on the gliclazide release from HPMC matrix tablets. This aim will be achieved by evaluating different grades and sources of HPMC as a release controlling polymer and by investigating the effect of polymer modification on the drug release pattern. The influence of additives as well as the influence of process variables on the performance of gliclazide matrix tablets will be assessed. |