Preparation, Characterization, and Evaluation of Cytotoxicity of Fast Dissolving Hydrogel Based Oral Thin Films Containing Pregabalin and Methylcobalamin
The oral availability of many drugs is problematic due to the pH of the stomach, enzymes, and first-pass effects through the liver. However, especially geriatric, pediatric, bedridden, or mentally handicapped patients and those with dysphagia have difficulty swallowing or chewing solid dosage forms....
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-02-01
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| Series: | Gels |
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| Online Access: | https://www.mdpi.com/2310-2861/9/2/147 |
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| author | Emrah Özakar Rukiye Sevinç-Özakar Bilal Yılmaz |
| author_facet | Emrah Özakar Rukiye Sevinç-Özakar Bilal Yılmaz |
| author_sort | Emrah Özakar |
| collection | DOAJ |
| description | The oral availability of many drugs is problematic due to the pH of the stomach, enzymes, and first-pass effects through the liver. However, especially geriatric, pediatric, bedridden, or mentally handicapped patients and those with dysphagia have difficulty swallowing or chewing solid dosage forms. Oral Thin Films (OTFs) are one of the new drug delivery systems that can solve these problems. Pregabalin (PG) and Methylcobalamin (MC), which are frequently preferred for pain originating in the central nervous system, were brought together for the first time using OTF technology in this study. In this study, a quantification method for PG and MC was developed and validated simultaneously. Optimum formulations were selected with organoleptic and morphological controls, moisture absorption capacity, swelling capacity, percent elongation, foldability, pH, weight variability, thickness, disintegration time, and transparency tests on OTFs prepared by the solvent pouring method. Content uniformity, dissolution rate, determination of release kinetics, SEM, XRD, FT-IR, DSC, long-term stability, and cytotoxicity studies on the tongue epithelial cell line (SCC-9) were performed on selected OTFs. As a result, OTFs containing PG-MC, which are non-toxic, highly flexible, transparent, compatible with intraoral pH, with fast disintegration time (<30 s), and acceptable in taste and appearance, have been developed successfully. |
| first_indexed | 2024-03-11T08:47:42Z |
| format | Article |
| id | doaj.art-3808a8e7a2ab4b9cae48133cc4938a25 |
| institution | Directory Open Access Journal |
| issn | 2310-2861 |
| language | English |
| last_indexed | 2024-03-11T08:47:42Z |
| publishDate | 2023-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Gels |
| spelling | doaj.art-3808a8e7a2ab4b9cae48133cc4938a252023-11-16T20:39:52ZengMDPI AGGels2310-28612023-02-019214710.3390/gels9020147Preparation, Characterization, and Evaluation of Cytotoxicity of Fast Dissolving Hydrogel Based Oral Thin Films Containing Pregabalin and MethylcobalaminEmrah Özakar0Rukiye Sevinç-Özakar1Bilal Yılmaz2Department of Pharmaceutical Technology, Faculty of Pharmacy, Atatürk University, 25240 Erzurum, TurkeyDepartment of Pharmaceutical Technology, Faculty of Pharmacy, Atatürk University, 25240 Erzurum, TurkeyDepartment of Analytical Chemistry, Faculty of Pharmacy, Atatürk University, 25240 Erzurum, TurkeyThe oral availability of many drugs is problematic due to the pH of the stomach, enzymes, and first-pass effects through the liver. However, especially geriatric, pediatric, bedridden, or mentally handicapped patients and those with dysphagia have difficulty swallowing or chewing solid dosage forms. Oral Thin Films (OTFs) are one of the new drug delivery systems that can solve these problems. Pregabalin (PG) and Methylcobalamin (MC), which are frequently preferred for pain originating in the central nervous system, were brought together for the first time using OTF technology in this study. In this study, a quantification method for PG and MC was developed and validated simultaneously. Optimum formulations were selected with organoleptic and morphological controls, moisture absorption capacity, swelling capacity, percent elongation, foldability, pH, weight variability, thickness, disintegration time, and transparency tests on OTFs prepared by the solvent pouring method. Content uniformity, dissolution rate, determination of release kinetics, SEM, XRD, FT-IR, DSC, long-term stability, and cytotoxicity studies on the tongue epithelial cell line (SCC-9) were performed on selected OTFs. As a result, OTFs containing PG-MC, which are non-toxic, highly flexible, transparent, compatible with intraoral pH, with fast disintegration time (<30 s), and acceptable in taste and appearance, have been developed successfully.https://www.mdpi.com/2310-2861/9/2/147dysphagiageriatricpediatricoral thin filmOTFpregabalin |
| spellingShingle | Emrah Özakar Rukiye Sevinç-Özakar Bilal Yılmaz Preparation, Characterization, and Evaluation of Cytotoxicity of Fast Dissolving Hydrogel Based Oral Thin Films Containing Pregabalin and Methylcobalamin Gels dysphagia geriatric pediatric oral thin film OTF pregabalin |
| title | Preparation, Characterization, and Evaluation of Cytotoxicity of Fast Dissolving Hydrogel Based Oral Thin Films Containing Pregabalin and Methylcobalamin |
| title_full | Preparation, Characterization, and Evaluation of Cytotoxicity of Fast Dissolving Hydrogel Based Oral Thin Films Containing Pregabalin and Methylcobalamin |
| title_fullStr | Preparation, Characterization, and Evaluation of Cytotoxicity of Fast Dissolving Hydrogel Based Oral Thin Films Containing Pregabalin and Methylcobalamin |
| title_full_unstemmed | Preparation, Characterization, and Evaluation of Cytotoxicity of Fast Dissolving Hydrogel Based Oral Thin Films Containing Pregabalin and Methylcobalamin |
| title_short | Preparation, Characterization, and Evaluation of Cytotoxicity of Fast Dissolving Hydrogel Based Oral Thin Films Containing Pregabalin and Methylcobalamin |
| title_sort | preparation characterization and evaluation of cytotoxicity of fast dissolving hydrogel based oral thin films containing pregabalin and methylcobalamin |
| topic | dysphagia geriatric pediatric oral thin film OTF pregabalin |
| url | https://www.mdpi.com/2310-2861/9/2/147 |
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