ABSTRACT
Under the guidance of Chinese Pharmacopoeia (2020 edition), the functionality-related characteristics of hydroxypropyl methylcellulose (HPMC) type 2208 from imported A manufacturer, domestic S manufacturer, domestic T manufacturer and different batches of the same manufacturer were characterized. The principal component analysis was used to comprehensively evaluate the functionality-related characteristics. The results were as follows: hydroxypropyl methylcellulose had no significant difference in viscosity and molecular weight distribution between different manufacturers, and there were significant differences in the cumulative particle size distribution of the sample reaches 50% (d50) and 90% (d90), bulk density, tap density and Carr's index. The HPMC from A manufacturer have the biggest inter-batch difference of particle size and their inter-batch difference of polydispersion coefficientis smaller than S manufacturer. Domestic manufactures have the largest inter-batch difference in other functionality-related characteristics. The three principal components were extracted by principal component analysis, and the variance contribution rate reached 89.44%, indicating that the extracted principal components can explain all the data well. By constructing a comprehensive evaluation model, the comprehensive score ranking of all HPMC samples is obtained: S manufacturer > A manufacturer > T manufacturer.
ABSTRACT
OBJECTIVE: To provide reference and consideration for pharmaceutical development by expounding the basic considerations for the selection of freeze-dried injection excipients. METHODS: The excipients in freeze-dried injections approved by FDA in recent years have been listed, and the composition of excipients in the preparations and the maximum amount of excipients contained were summarized. The issues to be considered in the selection of freeze-dried injections were discussed. RESULTS: One quarter of the freeze-dried injections that have been marketed do not use excipients, while the most commonly used excipients are bulking agents, buffering agents and pH adjusters. Other excipients include solubilizing agent, antioxidants, etc.. CONCLUSION: The selection of freeze-dried injection excipients should focus on safety, formulation rationality, functionality-related characteristics and control of excipients.