A Novel Rapid Quantitative Analysis of Drug Migration on Tablets Using Laser Induced Breakdown Spectroscopy

スポンサーリンク

概要

• 論文の詳細を見る

• There have been few reports wherein drug migration from the interior to the surface of a tablet has been analyzed quantitatively until now. In this paper, we propose a novel, rapid, quantitative analysis of drug migration in tablets using laser induced breakdown spectroscopy (LIBS). To evaluate drug migration, model tablets containing nicardipine hydrochloride as active pharmaceutical ingredient (API) were prepared by a conventional wet granulation method. Since the color of this API is pale yellow and all excipients are white, we can observe the degree of drug migration by visual inspection in these model tablets. In order to prepare tablets with different degrees of drug migration, the temperature of the drying process after tableting was varied between 50 to 80 °C. Using these manifold tablets, visual inspection, Fourier transform (FT)-IR mapping and LIBS analysis were carried out to evaluate the drug migration in the tablets. While drug migration could be observed using all methods, only LIBS analysis could provide quantitative analysis wherein the average LIBS intensity was correlated with the degree of drug migration obtained from the drying temperature. Moreover, in this work, we compared the sample preparation, data analysis process and measurement time for visual inspection, FT-IR mapping and LIBS analysis. The results of the comparison between these methods demonstrated that LIBS analysis is the simplest and the fastest method for migration monitoring. From the results obtained, we conclude that LIBS analysis is one of most useful process analytical technology (PAT) tools to solve the universal migration problem.

著者

• Iwamoto Kiyoshi

  Formulation Res. Lab. Eisai Co. Ltd.

• Takeuchi Hirofumi

  Laboratory Of Pharmaceutical Engineering Gifu Pharmaceutical University

• Yokoyama Makoto

  Formulation Research Laboratory, Eisai Co., Ltd.

• Tourigny Martine

  Pharm Laser

• Moroshima Kenji

  Formulation Research Laboratory, Eisai Co., Ltd.

• Suzuki Junsuke

  Formulation Research Laboratory, Eisai Co., Ltd.

• Sakai Miyako

  Formulation Research Laboratory, Eisai Co., Ltd.

関連論文

• Formation of Spherical Micelles by the Novel Platelet Activating Factor Receptor Antagonist, E5880
• The Effect of the Lipid A Analog, E5531 on Fever Induced by Endotoxin from Escherichia coli
• Engineering of poly(DL-lactic-co-glycolic acid) nanocomposite particles for dry powder inhalation dosage forms of insulin with the spray-fluidized bed granulating system
• Evaluation of the Disintegration Properties of Commercial Famotidine 20mg Orally Disintegrating Tablets Using a Simple New Test and Human Sensory Test
• A Novel Rapid Quantitative Analysis of Drug Migration on Tablets Using Laser Induced Breakdown Spectroscopy
• Anomalous dissolution property enhancement of naringenin from spray-dried particles with α-glucosylhesperidin
• Improvements in Transfection Efficiency with Chitosan Modified Poly(DL-lactide-co-glycolide) Nanospheres Prepared by the Emulsion Solvent Diffusion Method, for Gene Delivery
• Improving Powder Flow Properties of a Direct Compression Formulation Using a Two-Step Glidant Mixing Process
• Development of a Novel and Simple Method to Evaluate Disintegration of Rapidly Disintegrating Tablets

スポンサーリンク