The Effect of Hollow Capsules on Consistency Assessment of Capsules
On April 17 to 18, LEFAN participated in the 1st China (Shanghai) Pharmaceutical Adjuvant Application Summit and the 1st APICHINA exchange meeting on quality and curative effect consistency assessment of generic drugs – “Gritty, Icebreaking & Re-sailing” drug forum in Shanghai. On the meetings, Mr. Zheng Zhiwen, QC manager of LEFAN, on behalf of LEFAN, from the manufacturer’s perspective of capsules, analyzed the effect of hollow capsules on the curative consistency assessment of capsules.
Along with the upgrading of quality consistency assessment of generic drugs, associated approval, the GMP certification and the pharmacopoeia standards, the pharmaceutical adjuvant industry will have its unprecedented opportunities and challenges. Mr. Zheng Zhiwen, based on consistency assessment by way of external dissolution test for drug manufacturers as permitted in the View on Quality & Curative Effect Consistency Assessment of Generic Drugs Drawn by the General Office of the State Council, starting with three aspects of raw and auxiliary materials of hollow capsules, quality attribute of capsules and the drug interaction, made an acute analysis on the effect of disintegration and dissolution function of hollow capsules to the eternal dissolution performance of capsules.
The consistency assessment of generic drugs puts forward higher requirements for pharmaceutical adjuvant, and it is particularly important for drug manufacturers to select the variety and specifications of accessories. Levecaps, from whether the selection of raw and auxiliary materials, quality standards, or production process, ensures the consistency with drugs originally developed abroad. In the meanwhile, we have our own professional team for consistency assessment, with professional equipment, and may carry out relevant consistency assessment independently. For example: the consistency test between drugs originally developed abroad and generic drugs for hollow capsules project, the consistency test for different batches of the same manufacturer, the compatibility test between capsules and drug, and so on.
It is our mission to adhere to the customer’s demand, and provide positively professional services from the point of a capsule-maker. We shall, aiming at the customer’s capsule formulation, and based on our professional experiences in hollow capsules manufacture for years, provide customers with the groundwork of consistency assessment relating to hollow capsules.