Design of Experiments for Critical Material Attributes Assessment of Linagliptin and Metformin Fixed-dose Combination Tablets (Record no. 15521)
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| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20211120130911.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 211120b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 14688 |
| Author | Kim, Kang Min |
| 245 ## - TITLE STATEMENT | |
| Title | Design of Experiments for Critical Material Attributes Assessment of Linagliptin and Metformin Fixed-dose Combination Tablets |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.55(3), Jul-Sep |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Banagalore |
| Name of publisher, distributor, etc. | Association of Pharmaceutical Teachers of India (APTI) |
| Year | 2021 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 701-708p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Aim of work: This study aimed to determine the amount of excipients in the critical material attributes of linagliptin and metformin sustained release (SR) fixed-dose combination (FDC) tablets using design of experiments (DoE). Methods: A 23 full factorial design with three center points was performed. For the screening of excipients, 3-factor responses (mannitol, sodium starch glycolate and pregelatinized starch for linagliptin; hydroxypropyl methylcellulose, sodium carboxymethyl cellulose (CMC) and hydroxypropyl cellulose for metformin), 2-levels and 1-center (n=3) point with three responses (friability, assay and dissolution) were applied to the DoE batch using Design-Expert. Results: Most excipients were an important factor in the friability, assay and dissolution results (P<0.05). In the screening of excipients, mannitol (40-60 mg) and pregelatinized starch (40-60 mg) with sodium starch glycolate (5 mg) for linagliptin and hydroxypropyl cellulose (15-23 mg) and CMC (40-55 mg) with hydroxypropyl methylcellulose (260 mg) for metformin were optimal. Conclusion: In summary, selection for the amount of excipients can be defined through levels of risk based on three responses. It can be concluded that the ranges of excipients leading to high quality (low friability and optimal ranges of assay and dissolution) for the screening of excipients were successfully observed by the DoE approach. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4639 |
| Topical term or geographic name entry element | PHARMACEUTICS |
| 773 0# - HOST ITEM ENTRY | |
| Title | Indian journal of pharmaceutical education and research |
| Place, publisher, and date of publication | Bengluru Association of Pharmaceutical Teachers of India (APTI) |
| International Standard Serial Number | 0019-5464 |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://www.ijper.org/sites/default/files/IndJPhaEdRes-55-3-701.pdf |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 20/11/2021 | 2021-2022326 | 20/11/2021 | 20/11/2021 | Articles Abstract Database |