Primary Particle Imaging of Active Pharmaceutical Ingredient in Formulations by Raman Crystal Orientation Mapping
Project/Area Number |
16K08213
|
Research Category |
Grant-in-Aid for Scientific Research (C)
|
Allocation Type | Multi-year Fund |
Section | 一般 |
Research Field |
Physical pharmacy
|
Research Institution | Shujitsu University |
Principal Investigator |
Moriyama Kei 就実大学, 薬学部, 准教授 (60345163)
|
Project Period (FY) |
2016-04-01 – 2019-03-31
|
Project Status |
Completed (Fiscal Year 2018)
|
Budget Amount *help |
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2018: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2017: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2016: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
|
Keywords | ラマン分光法 / 製剤 / 原薬 / 一次粒子 / イメージング / 溶出 / 粉砕 / 分級 / 結晶構造 / フェニトイン / 粒度分布 / 粒子径 |
Outline of Final Research Achievements |
The aim of this study was to develop an imaging method of primary particles of active pharmaceutical ingredients (API) in formulations by Raman crystal orientation mapping (RCOM) method. Raman spectrum is determined based on the angle between the polarization direction of excitation laser and the crystal axes; therefore, the spectral transition is observed on the boundary of the primary particles of the API, which forms the concept of RCOM. We applied this technique to visualize the primary particles in the formulations using phenytoin and cilostazol as the model API. Also, we performed dissolution tests for model tablets of phenytoin and cilostazol and revealed the relationship between the primary particle morphology and the dissolution rate. We believe that the application of the RCOM method would facilitate visualization of the primary particles of various APIs in a formulation for the better understanding of the dissolution behavior of the formulation.
|
Academic Significance and Societal Importance of the Research Achievements |
医薬品の研究・製造現場において、医薬品原薬の分散状態を簡便に可視化できるラマンイメージング法は極めて重要な分析ツールとなっている。ただし、ここで可視化できている原薬像はあくまでもその凝集塊のものであり、一次粒子の形態まで把握できるイメージング法は本研究開始当初には存在していなかった。近年開発されている医薬品原薬は難溶性のものが多く、一次粒子の粒子形態がその溶出挙動に極めて重要な要因となっている。本研究で開発した製剤中原薬の一次粒子イメージング法は、製剤からの原薬溶出挙動の予測および評価をより高次元で行うことを可能とするものであり、医薬品の品質安定化に大きく寄与するものと考えられる。
|
Report
(4 results)
Research Products
(16 results)
-
-
[Journal Article] Applications of Raman Spectroscopy on Quality Control of Hospital Formulations2018
Author(s)
Moriyama, K., Yakushige, A., Yamamoto, M., Ogura, Y., Fukushima, S., Kamei, T., Akagi, S., Tokuda, H., Takayanagi, K., Takami, Y.
-
Journal Title
YAKUGAKU ZASSHI
Volume: 138
Issue: 12
Pages: 1561-1568
DOI
NAID
ISSN
0031-6903, 1347-5231
Year and Date
2018-12-01
Related Report
Peer Reviewed / Open Access
-
-
-
-
-
-
-
-
-
-
-
-
-
-