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3D printing is an additive manufacturing technology with the help of digital control. Since FDA approved the first 3D printing drug in 2015, its research enthusiasm in the pharmaceutical field has been increasing year by year. In printing technology, fused deposition molding (FDM) and semi-solid extrusion (SSE) are the two most widely used extrusion molding technologies. In this review, recent advances of pharmaceutical 3D printing extrusion molding technology are reviewed from six aspects: mechanism, equipment, pharmaceutical excipients, applications, design and industrialization prospects of extrusion molding technology.
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The taste of drugs has an important impact on the compliance of patients, but most of the active drug ingredients have an uncomfortable taste, especially traditional Chinese medicine. Through a variety of pharmaceutical excipients with taste masking properties combined with corresponding technologies can improve the taste of drugs and the characteristics of other dosage forms, so as to improve patient compliance. Here, we mainly summarize the auxiliary materials used for taste masking, explain the mechanism of taste masking from the point of view of excipients and introduces related uses, so as to provide reference for further research on taste masking of pediatric preparations.
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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.
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OBJECTIVE: To analyze the general situation of pharmaceutical excipients standard in Chinese Pharmacopoeia 2020 edition and understand the standards accurately. METHODSE: This article focuses on the overall information of standard, the changes of working mechanism, the framework of the standard system and the characteristics of all pharmaceutical excipients standards in the 2020 edition of Chinese Pharmacopoeia. RESULTS: It has significantly improved that the number of standards, the standard system and the standard formation mechanism of the 2020 edition of China Pharmacopoeia. CONCLUSION: The Chinese Pharmacopoeia will continue to strengthen the construction of a standard system for pharmaceutical excipients, promote industrial upgrading and improve supervision efficiency.
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Objective To develop a rapid method for the detection of toxic adulterant (diethylene glycol) in pharmaceuti-cal excipient (glycerol) .Method The detection sensitivity of Raman/near infrared (NIR) spectroscopy combined with moving window correlation coefficient (MWCC) method was evaluated .Results The detection sensitivity of Raman spectroscopy was superior to that of NIR spectroscopy and with the assistance of MWCC method ;the sensitivity had been further improved . Conclusion Raman spectroscopy has the potential to become the effective method in the on-site detection of toxic adulterant in pharmaceutical excipient .
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OBJECTIVE: To investigate the compatibility of hollow hydroxypropyl starch capsules with drug particles of ofloxacin. METHODS: The capsules were placed in conditions of high temperature of 40℃ or high humidity of (75 ± 5)% RH for 5 and 10 d, respectively. The contents and related substances were determined by high performance liquid chromatography (HPLC), and the changes in the drug appearance and colors were observed. RESULTS: After being stored under the conditions of high temperature and high humidity for 5 and 10 d, the contents of ofloxacin were in the range of 90% - 110%, and no new impurities were detected, which conformed to the quality standard of ofloxacin capsules in the Chinese Pharmacopoeia 2010 edition. CONCLUSION: There is good compatibility between ofloxacin and hollow hydroxypropyl starch capsules, which is consistent with the test results of gelatin capsules.
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Pharmaceutical excipients are important ingredients of drugs, and the quality of it directly related to the safety of drug. Compared to the 2010 edition, one of the most significant improvement of the 2015 edition of Chinese pharmacopoeia is the monographs of pharmaceutical excipients will be available in an individual book (Chinese Pharmacopoeia Book IV). And also, some new features will be found in the new edition: the doubled varieties of chronicled pharmaceutical excipients, the application of new techniques, the strict standards of the excipients for injection, the establishment of functionality-related characteristics. This article will interpret the developing trend of the standards of pharmaceutical excipients and the effect of the trend on the entire pharmaceutical industry in the future via the improvement of Chinese Pharmacopoeia.
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To establish a GC method to determine the related substances in pharmaceutical excipient benzyl alcohol. Methods:A GC method was used with an Agilent DB-wax eapillary column(0. 32 mm × 30 m,1. 8 μm)and programming temperature. The initial temperature was 50℃, and then raised to 220℃ with a rate of 5℃·min-1 and maintained for 35min. The detector was FID. The temperature of the injection port was 200℃,and the detector temperature was 310℃. The results were confirmed by GC-MS. Results:Within a certain range,the peak area and concentration of every impurity had a good linear relationship (r≥0. 999 9). The recovery was between 96. 1% and 102. 7%. The quantitative limit was between 1. 37-3. 63 ng. Toluene, benzyl chloride, benzalde-hyde and benzyl ether were found out in the samples. Conclusion:The method is accurate and convenient, and suitable for the quanti-tative determination of related substances in pharmaceutical excipient benzyl alcohol.