Evaluation of Monolayer and Bilayer Buccal Films Containing Metoclopramide
The objective of this study was to develop buccal film formulations containing metoclopramide hydrochloride monohydrate (MCP) with and without a backing layer and to evaluate their release properties and physiochemical stability. The crystallization of MCP in the polymer matrix was monitored with im...
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2024-03-01
|
| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/16/3/354 |
| _version_ | 1797239664728342528 |
|---|---|
| author | Blaž Grilc Odon Planinšek |
| author_facet | Blaž Grilc Odon Planinšek |
| author_sort | Blaž Grilc |
| collection | DOAJ |
| description | The objective of this study was to develop buccal film formulations containing metoclopramide hydrochloride monohydrate (MCP) with and without a backing layer and to evaluate their release properties and physiochemical stability. The crystallization of MCP in the polymer matrix was monitored with image analysis techniques for rapid and scalable observation. The results showed that the addition of a protective layer and its thickness significantly affected the release rate and crystallization behavior of MCP in the formulations. The crystallization of MCP increased over time, and certain formulations showed higher susceptibility to crystallization. To understand the factors affecting the crystallization of MCP, the relationship between the viscosity and pH of the casting solution was examined, but no significant correlation was found. A significant correlation was observed between the plasticizer concentration and the physical state of MCP. Through a systematic Design of Experiment (DOE) approach, an optimal formulation was devised, successfully preventing crystallization of the active ingredient. However, enhancing the overall chemical stability of the formulated product remains a challenge. |
| first_indexed | 2024-04-24T17:55:08Z |
| format | Article |
| id | doaj.art-7e818d43a8f34a3987f5aba569d4d91f |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-04-24T17:55:08Z |
| publishDate | 2024-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-7e818d43a8f34a3987f5aba569d4d91f2024-03-27T13:59:41ZengMDPI AGPharmaceutics1999-49232024-03-0116335410.3390/pharmaceutics16030354Evaluation of Monolayer and Bilayer Buccal Films Containing MetoclopramideBlaž Grilc0Odon Planinšek1Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, SloveniaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, SloveniaThe objective of this study was to develop buccal film formulations containing metoclopramide hydrochloride monohydrate (MCP) with and without a backing layer and to evaluate their release properties and physiochemical stability. The crystallization of MCP in the polymer matrix was monitored with image analysis techniques for rapid and scalable observation. The results showed that the addition of a protective layer and its thickness significantly affected the release rate and crystallization behavior of MCP in the formulations. The crystallization of MCP increased over time, and certain formulations showed higher susceptibility to crystallization. To understand the factors affecting the crystallization of MCP, the relationship between the viscosity and pH of the casting solution was examined, but no significant correlation was found. A significant correlation was observed between the plasticizer concentration and the physical state of MCP. Through a systematic Design of Experiment (DOE) approach, an optimal formulation was devised, successfully preventing crystallization of the active ingredient. However, enhancing the overall chemical stability of the formulated product remains a challenge.https://www.mdpi.com/1999-4923/16/3/354image analyticsRaman microscopycrystallizationbuccal filmsbilayer |
| spellingShingle | Blaž Grilc Odon Planinšek Evaluation of Monolayer and Bilayer Buccal Films Containing Metoclopramide Pharmaceutics image analytics Raman microscopy crystallization buccal films bilayer |
| title | Evaluation of Monolayer and Bilayer Buccal Films Containing Metoclopramide |
| title_full | Evaluation of Monolayer and Bilayer Buccal Films Containing Metoclopramide |
| title_fullStr | Evaluation of Monolayer and Bilayer Buccal Films Containing Metoclopramide |
| title_full_unstemmed | Evaluation of Monolayer and Bilayer Buccal Films Containing Metoclopramide |
| title_short | Evaluation of Monolayer and Bilayer Buccal Films Containing Metoclopramide |
| title_sort | evaluation of monolayer and bilayer buccal films containing metoclopramide |
| topic | image analytics Raman microscopy crystallization buccal films bilayer |
| url | https://www.mdpi.com/1999-4923/16/3/354 |
| work_keys_str_mv | AT blazgrilc evaluationofmonolayerandbilayerbuccalfilmscontainingmetoclopramide AT odonplaninsek evaluationofmonolayerandbilayerbuccalfilmscontainingmetoclopramide |