Evaluating the Release of Different Commercial Orally Modified Niacin Formulations In Vitro
Objectives: To evaluate the release profile of different modified-release oral formulations of niacin, such as immediate-release (IR) powder and tablets, timed-release (TR) caplets, extended-release (ER) capsules, and controlled-release (CR) tablets, to assure their defined release pattern and corre...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-07-01
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| Series: | Polymers |
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| Online Access: | https://www.mdpi.com/2073-4360/15/14/3046 |
| _version_ | 1797587639750098944 |
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| author | Christiane Chbib Md. Abdur Rashid Sarthak M. Shah Mohsin Kazi Mohammad N. Uddin |
| author_facet | Christiane Chbib Md. Abdur Rashid Sarthak M. Shah Mohsin Kazi Mohammad N. Uddin |
| author_sort | Christiane Chbib |
| collection | DOAJ |
| description | Objectives: To evaluate the release profile of different modified-release oral formulations of niacin, such as immediate-release (IR) powder and tablets, timed-release (TR) caplets, extended-release (ER) capsules, and controlled-release (CR) tablets, to assure their defined release pattern and correlate this release with their matrix polymers. Significance: Niacin is used to manage hyperlipidemia by reducing cutaneous flushing and hepatotoxicity adverse events. The release profiles of different types of modified-release dosage forms depend on the types of coating materials (polymers) used in the matrix formation. Although different types of niacin formulations exist, none of the niacin dissolution profiles have been evaluated and compared in the literature. Methods: Four commercial orally modified-release niacin brands were collected from a local CVS pharmacy retail store, in Miami, FL, USA. The in vitro release study was conducted in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) conditions. Results: The results of the release patterns of four niacin-modified dosage forms (IR, ER, TR, and CR) were aligned with their release definitions. However, the CR dosage form did not follow an ideal release pattern. Conclusions: The release rate of niacin in vitro was pH dependent, which was confirmed by the similarity factor (f2) results. All the f2 comparison values were below 50 in both the SIF and SGF media, while all the comparisons were below the f2 values for all brands in the SIF media. |
| first_indexed | 2024-03-11T00:42:43Z |
| format | Article |
| id | doaj.art-2365ebcdd8474d2abf2e4f5ee20852f4 |
| institution | Directory Open Access Journal |
| issn | 2073-4360 |
| language | English |
| last_indexed | 2024-03-11T00:42:43Z |
| publishDate | 2023-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Polymers |
| spelling | doaj.art-2365ebcdd8474d2abf2e4f5ee20852f42023-11-18T21:02:35ZengMDPI AGPolymers2073-43602023-07-011514304610.3390/polym15143046Evaluating the Release of Different Commercial Orally Modified Niacin Formulations In VitroChristiane Chbib0Md. Abdur Rashid1Sarthak M. Shah2Mohsin Kazi3Mohammad N. Uddin4Department of Pharmaceutics, College of Pharmacy, Larkin University, 18301 N Miami, Miami, FL 33169, USADepartment of Pharmaceutics, College of Pharmacy, King Khalid University, Al Faraa, Abha 62223, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, Mercer University, 3001 Mercer University Drive, Atlanta, GA 30341, USADepartment of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, Mercer University, 3001 Mercer University Drive, Atlanta, GA 30341, USAObjectives: To evaluate the release profile of different modified-release oral formulations of niacin, such as immediate-release (IR) powder and tablets, timed-release (TR) caplets, extended-release (ER) capsules, and controlled-release (CR) tablets, to assure their defined release pattern and correlate this release with their matrix polymers. Significance: Niacin is used to manage hyperlipidemia by reducing cutaneous flushing and hepatotoxicity adverse events. The release profiles of different types of modified-release dosage forms depend on the types of coating materials (polymers) used in the matrix formation. Although different types of niacin formulations exist, none of the niacin dissolution profiles have been evaluated and compared in the literature. Methods: Four commercial orally modified-release niacin brands were collected from a local CVS pharmacy retail store, in Miami, FL, USA. The in vitro release study was conducted in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) conditions. Results: The results of the release patterns of four niacin-modified dosage forms (IR, ER, TR, and CR) were aligned with their release definitions. However, the CR dosage form did not follow an ideal release pattern. Conclusions: The release rate of niacin in vitro was pH dependent, which was confirmed by the similarity factor (f2) results. All the f2 comparison values were below 50 in both the SIF and SGF media, while all the comparisons were below the f2 values for all brands in the SIF media.https://www.mdpi.com/2073-4360/15/14/3046niacin (nicotinic acid)modified-release tabletsin vitro dissolution studiesquantificationbioavailabilityUV spectroscopy |
| spellingShingle | Christiane Chbib Md. Abdur Rashid Sarthak M. Shah Mohsin Kazi Mohammad N. Uddin Evaluating the Release of Different Commercial Orally Modified Niacin Formulations In Vitro Polymers niacin (nicotinic acid) modified-release tablets in vitro dissolution studies quantification bioavailability UV spectroscopy |
| title | Evaluating the Release of Different Commercial Orally Modified Niacin Formulations In Vitro |
| title_full | Evaluating the Release of Different Commercial Orally Modified Niacin Formulations In Vitro |
| title_fullStr | Evaluating the Release of Different Commercial Orally Modified Niacin Formulations In Vitro |
| title_full_unstemmed | Evaluating the Release of Different Commercial Orally Modified Niacin Formulations In Vitro |
| title_short | Evaluating the Release of Different Commercial Orally Modified Niacin Formulations In Vitro |
| title_sort | evaluating the release of different commercial orally modified niacin formulations in vitro |
| topic | niacin (nicotinic acid) modified-release tablets in vitro dissolution studies quantification bioavailability UV spectroscopy |
| url | https://www.mdpi.com/2073-4360/15/14/3046 |
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