Pharmaceutical Excipients Affect Drug Purity And Quality And Safety - Pharmaceutical Excipients -

Pharmaceutical Excipients Direct impact on the purity of pharmaceutical preparations of the quality

, stability and security. The presence of impurities change the accessories of the moisture function, may lead to moisture absorption, agglomeration, poor mobility, mixed with drugs is not easy to affect product quality. In addition, some auxiliary impurity structure is not clear, and the drug may be physical, chemical and pharmacological aspects of the compatibility of change itself, there are contraindications or safety hazards, thus affecting the stability of drugs, the efficacy and safety.

"Medical supplies, and in fact the quality of the difference between industrial accessories mainly in the purity, 'Let the two drugs' event in the accessories because the purity of propylene glycol is not high, appear less serious consequences." Chinese medicine University Professor Ng says that the auxiliary materials and drugs, because the same active ingredients through the whole body metabolism, excipients impurities Drug Quality Greatly. Currently, the domestic part of the medical supplements manufacturer R & D capability is not strong, coupled with recent Chemical industry Class, food companies have involved medical supplements market competition, many enterprises to reduce costs, reduce the purity of some accessories, which caused quality problems. More important, many drug manufacturers do not really recognize the quality of ingredients on the important role of agents, look at the price, regardless of quality, to reduce costs, use of industrial accessories instead of pharmaceutical excipients, for the safe use of drugs planted in a huge hidden dangers.

State Food and Drug Administration Center for Drug Evaluation, anti-infective A project leader, said Zhang Zhefeng, pharmaceutical excipients in the production process, as some manufacturers such as synthesis of link quality control problems, it is difficult to ensure production of high purity products, some species occur in one or several specific impurities. Such as polyethylene Pyrrole Pyrrolidone (PVP), benzoic acid, polyethylene glycol (PEG), Tween accessories in the impurities is the peroxide often; magnesium stearate, polyethylene glycol (PEG), non-volatile oil may contain anti- oxidants; lactose is contained in the residual protein, aldehydes and reducing sugars; benzyl alcohol in benzene formaldehyde; cellulose containing lignin and hemicellulose; polyethylene glycol (PEG) containing formaldehyde, peroxides and organic acids and so on. These accessories impurities on drug quality are clear, such as duloxetine tablets, coating materials, HPMC acetyl succinate trace impurities (free succinate) and API Interact to produce new impurities?? N-succinyl duloxetine, duloxetine such impurities directly affect the quality of films.

"In general, chemical inert pharmaceutical excipients, and proved by experiments in medicine is also a non-activity. And accessories in some impurities may not be non-active substances, are likely to impact the security agents." Hefei cubic Pharmacy Drug Research Institute Ltd., said Chen Jun, impurities in the use of their environment will produce the pharmacological effects of uncertainty, and thus to the safety of products bring hidden dangers. Meanwhile, the impurities will be mutual between the chemical reaction, resulting in uncertainty of new impurities, these impurities further with new drugs or new recurrence of the role of impurities, increase product safety hazards. Some species of impurities accessories directly pose a threat to human health, such as lecithin in lysophosphatidic, lactose in the remaining protein in the ethylene oxide and Tween Vitamin c antioxidant is oxidized toxic impurities.

In addition, impurities in pharmaceutical excipients on the stability of drugs should not be ignored. Zhang Zhefeng that, because of impurities in pharmaceutical excipients can not guarantee its chemical inertia, it is possible in the drug production process of preparation and storage of chemical reaction with the drug itself, consume drugs and to generate new impurities, thus affecting the stability of products. For example, when PVP contains peroxide, the tetracycline class Antibiotic Preparation used, because peroxide induced oxidation reactions can lead to preparation of the oxidation products increased significantly; as condensation caused by the interaction of trace impurities can lead to acetaldehyde with amino groups of drug stability becomes worse.

"Raw materials, production technology, production process control and other impurities will affect the production of pharmaceutical excipients, must be mature in a stable production process, based on strict quality control of raw materials, and strictly control the production process, scientific development and strict implementation product quality standards, to ensure the quality of the product. "Speaking about how to control the impurities in pharmaceutical excipients, CHEN stressed, above all, improve the existing standard system of medical accessories, sound quality evaluation system of Pharmaceutical Excipients; followed the establishment of accessories manufacturers and universities, research institutes, pharmaceutical companies an integrated technology platform to study and explore the development and application of new accessories and quality control issues; the third is to strengthen the auxiliary parameters of the production process monitoring, production of on-site inspection and production of raw materials traceability checks.

by:gaga

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