Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate

The development of new drugs that combine active ingredients for the treatment hypertension is critically essential owing to its offering advantages for both patients and manufacturers. In this study, for the first time, detailed development of a scalable process of film-coated bi-layer tablets cont...

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Autores principales:	Nguyen Thi Linh Tuyen, Le Quan Nghiem, Nguyen Duc Tuan, Phuoc Huu Le
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	bi-layer tablet metoprolol succinate amlodipine besylate processing conditions scalable process. Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/6970b94074de4ab4a31785a5d9973d25
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spelling	oai:doaj.org-article:6970b94074de4ab4a31785a5d9973d252021-11-25T18:40:46ZDevelopment of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate10.3390/pharmaceutics131117971999-4923https://doaj.org/article/6970b94074de4ab4a31785a5d9973d252021-10-01T00:00:00Zhttps://www.mdpi.com/1999-4923/13/11/1797https://doaj.org/toc/1999-4923The development of new drugs that combine active ingredients for the treatment hypertension is critically essential owing to its offering advantages for both patients and manufacturers. In this study, for the first time, detailed development of a scalable process of film-coated bi-layer tablets containing sustained-release metoprolol succinate and immediate-release amlodipine besylate in a batch size of 10,000 tablets is reported. The processing parameters of the manufacturing process during dry mixing-, drying-, dry mixing- completion stages were systematically investigated, and the evaluation of the film-coated bi-layer tablet properties was well established. The optimal preparation conditions for metoprolol succinate layer were 6 min- dry mixing with a high-speed mixer (120 rpm and 1400 rpm), 30-min drying with a fluid bed dryer, and 5-min- mixing completion at 25 rpm. For the preparation of amlodipine besylate layer, the optimal dry-mixing time using a cube mixer (25 rpm) was found to be 5 min. The average weight of metoprolol succinate layers and bi-layer tablets were controlled at 240–260 mg and 384–416 mg, respectively. Shewhart R chart and <inline-formula><math xmlns="http://www.w3.org/1998/Math/MathML" display="inline"><semantics><mover accent="true"><mi>X</mi><mo>¯</mo></mover></semantics></math></inline-formula> charts of all three sampling lots were satisfactory, confirming that the present scalable process was stable and successful. This study confirms that the manufacturing process is reproducible, robust; and it yields a consistent product that meets specifications.Nguyen Thi Linh TuyenLe Quan NghiemNguyen Duc TuanPhuoc Huu LeMDPI AGarticlebi-layer tabletmetoprolol succinateamlodipine besylateprocessing conditionsscalable process.Pharmacy and materia medicaRS1-441ENPharmaceutics, Vol 13, Iss 1797, p 1797 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	bi-layer tablet metoprolol succinate amlodipine besylate processing conditions scalable process. Pharmacy and materia medica RS1-441
spellingShingle	bi-layer tablet metoprolol succinate amlodipine besylate processing conditions scalable process. Pharmacy and materia medica RS1-441 Nguyen Thi Linh Tuyen Le Quan Nghiem Nguyen Duc Tuan Phuoc Huu Le Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate
description	The development of new drugs that combine active ingredients for the treatment hypertension is critically essential owing to its offering advantages for both patients and manufacturers. In this study, for the first time, detailed development of a scalable process of film-coated bi-layer tablets containing sustained-release metoprolol succinate and immediate-release amlodipine besylate in a batch size of 10,000 tablets is reported. The processing parameters of the manufacturing process during dry mixing-, drying-, dry mixing- completion stages were systematically investigated, and the evaluation of the film-coated bi-layer tablet properties was well established. The optimal preparation conditions for metoprolol succinate layer were 6 min- dry mixing with a high-speed mixer (120 rpm and 1400 rpm), 30-min drying with a fluid bed dryer, and 5-min- mixing completion at 25 rpm. For the preparation of amlodipine besylate layer, the optimal dry-mixing time using a cube mixer (25 rpm) was found to be 5 min. The average weight of metoprolol succinate layers and bi-layer tablets were controlled at 240–260 mg and 384–416 mg, respectively. Shewhart R chart and <inline-formula><math xmlns="http://www.w3.org/1998/Math/MathML" display="inline"><semantics><mover accent="true"><mi>X</mi><mo>¯</mo></mover></semantics></math></inline-formula> charts of all three sampling lots were satisfactory, confirming that the present scalable process was stable and successful. This study confirms that the manufacturing process is reproducible, robust; and it yields a consistent product that meets specifications.
format	article
author	Nguyen Thi Linh Tuyen Le Quan Nghiem Nguyen Duc Tuan Phuoc Huu Le
author_facet	Nguyen Thi Linh Tuyen Le Quan Nghiem Nguyen Duc Tuan Phuoc Huu Le
author_sort	Nguyen Thi Linh Tuyen
title	Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate
title_short	Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate
title_full	Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate
title_fullStr	Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate
title_full_unstemmed	Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate
title_sort	development of a scalable process of film-coated bi-layer tablet containing sustained-release metoprolol succinate and immediate-release amlodipine besylate
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/6970b94074de4ab4a31785a5d9973d25
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Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate

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