Formulation and physico-technical evaluation of a fixed dose combination of amlodipine and spironolactone in the management of hypertension

Chukwunonso Chukwudike Onwuzuligbo 1, *, Doris Mesoma Obi 1, Amarachukwu Ukamaka Onwuzuligbo 2, Cletus Nnodum Ibeh 1, Ogochukwu Augustina Meko 1, Ezinne Stephanie Iloh 3, Onyinye Blessing Okonkwo 4, Leonard Chukwunenye Maduabum 2 and Momoh Audu Mumuni 5

1Department of Pharmaceutics and Pharmaceutical Technology, Chukwuemeka Odumegwu Ojukwu University, Igbariam, Anambra State, Nigeria
2 Department of Pharmaceutics and Pharmaceutical Technology, Nnamdi Azikiwe University, Awka, Anambra State, Nigeria.
3 Department of Pharmacology and Toxicology, Chukwuemeka Odumegwu Ojukwu University, Igbariam, Anambra State, Nigeria.
4 Department of Pharmacognosy and Traditional Medicine, Chukwuemeka Odumegwu Ojukwu University, Igbariam, Anambra State, Nigeria.
5 Department of Pharmaceutics, University of Nigeria Nsukka, Nsukka, Enugu State, Nigeria.
 
Research Article
Magna Scientia Advanced Biology and Pharmacy, 2025, 14(02), 050-058
Article DOI: 10.30574/msabp.2025.14.2.0027
Publication history: 
Received on 26 January 2025; revised on 11 March 2025 accepted on 13 March 2025
 
Abstract: 
A fixed dose combination (FDC) product is the resulting product of a combination of more than one active pharmaceutical ingredients from different classes combined into a single dosage form. A total of 3 batches of amlodipine (ADB) and spironolactone (SPRN) have been formulated employing various excipients at different concentrations. Pre-compression studies such as angle of repose, bulk and tapped density, and post- compression evaluation such as: weight variation, hardness, friability. In-vitro release study were similarly evaluated using standard procedures. All the evaluation parameters such as weight variation, hardness, friability and in-vitro release study were within the official acceptable limits. The release of ADB was 58 % (2 % binder), 55.58 % (4 % binder) and 55.78 % (6 % binder)  after 10 min and gradually increased to 100 % drug release before 30 min of study; while release of SPRN was 48.64 % (2 % binder), 52.83 % (4 % binder) and 33.32 % (6 % binder) after initial 10 min and achieved 100 % release after 20 min of study. The FDC formulation of ADB/SPRN into an oral solid dosage form (tablet) was successful. The results of the physicochemical properties evaluated show a promising novel formulation for possible fixed dose combination of these molecules in the management of hypertension.
 
Keywords: 
Fixed Dose Combination; Amlodipine; Spironolactone; Excipients
 
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Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0