Analysis of Factors Related to Variation in Dissolution Profiles Estimated from Continuously Conducted Dissolution Tests of Generic Products
-
- Morita Tokio
- Division of Drugs, National Institute of Health Sciences
-
- Yoshida Hiroyuki
- Division of Drugs, National Institute of Health Sciences
-
- Abe Yasuhiro
- Division of Drugs, National Institute of Health Sciences
-
- Tomita Koji
- Aichi Prefectural Institute of Public Health
-
- Nakamura Akihiko
- Osaka Institute of Public Health
-
- Hada Chikako
- Kanagawa Prefectural Institute of Public Health
-
- Nakai Chiyori
- Kyoto Prefectural Institute of Public Health and Environment
-
- Kina Keishi
- Saitama Prefectural Institute of Public Health
-
- Takahashi Makoto
- Shizuoka Institute of Environment and Hygiene
-
- Uemura Nozomi
- Tokyo Metropolitan Institute of Public Health
-
- Yoneda Tetsuya
- Toyama Prefectural Institute for Pharmaceutical Research
-
- Yasui Maki
- Hyogo Prefectural Institute of Public Health Science
-
- Shintani Yoriko
- Fukuoka Institute of Health and Environmental Sciences
-
- Tomita Naomi
- Division of Drugs, National Institute of Health Sciences
-
- Inagaki Aoi
- Division of Drugs, National Institute of Health Sciences
-
- Izutsu Ken-ichi
- Division of Drugs, National Institute of Health Sciences
-
- Sato Yoji
- Division of Drugs, National Institute of Health Sciences
抄録
<p>The development of generic pharmaceuticals involves a bioequivalence study to ensure the therapeutic equivalence of the test formulation to the original innovative product. The formulation characteristics of generic products are expected to be maintained in the long term after approval. This study analyzed the factors contributing to the changes in the dissolution profiles of approved products during their life cycles. Cumulative data on the dissolution similarity of 1675 products of 127 ingredients tested by official laboratories in Japan were assessed according to Japanese bioequivalence guidelines with slight modifications. The products showing dissimilarities in dissolution profiles were analyzed for reporting year, therapeutic category, co-development, physical properties of the active pharmaceutical ingredient (API), and suspected reasons for dissolution change. The increase in the number of dissimilar products is related to the co-development of generic products. Although the solubility of the API was not associated with the dissolution change in the analysis of the total dissolution data, control of the API particle size is suggested to be important for drugs with poorly soluble APIs. Additionally, a risk factor for dissolution changes in the test solutions at a certain pH was the presence of acidic or basic residues. These results indicate the importance of proper development through a thorough evaluation of the formulation and process factors affecting the dissolution properties throughout the product lifecycle.</p>
収録刊行物
-
- CHEMICAL & PHARMACEUTICAL BULLETIN
-
CHEMICAL & PHARMACEUTICAL BULLETIN 72 (1), 28-35, 2024-01-01
公益社団法人 日本薬学会
- Tweet
詳細情報 詳細情報について
-
- CRID
- 1390017193115149696
-
- ISSN
- 13475223
- 00092363
-
- 本文言語コード
- en
-
- データソース種別
-
- JaLC
- Crossref
-
- 抄録ライセンスフラグ
- 使用不可