Formulation and In-vitro Evaluation of Extended Release Tamsulosin Hydrochloride and Solifenacin Succinate Combined Tablet as an Effective Drug for Benign Prostatic Hyperplasia

Subject Areas : Medicinal Chemistry

Negin Bakouee ¹ , Arash Mahboubi ² , Seyedali Sobhanian ^{3 *}

1 - Departement of Pharmaceutical Sciences, TeMS.C., Islamic Azad University, Tehran, Iran
2 - Department of Pharmaceutics, Faculty of Pharmacy, Pharmaceutical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3 - School of Pharmaceutical Sciences, Department of Medicinal Chemistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran

Received: 2024-11-04 Accepted : 2025-02-01 Published : 2025-07-07

Keywords: Benign Prostatic Hyperplasia, Combined Controlled Release Tablet, Tamsulosin Hydrochloride, Solifenacin Succinate,

Abstract :

Benign prostatic hyperplasia (BPH) is one of the common diseases in men. This disease includes characteristics such as the size of the prostate index, lower urinary tract problems (frequency, urgency in emptying urine, nocturnal urination, the feeling of incomplete emptying of the bladder and decreased urine flow pressure) and bladder outlet obstruction. Tamsulosin hydrochloride (I), which is an antagonist of alpha-receptors, and solifenacin succinate (II), which is an antagonist of muscarinic receptors, have been approved for the treatment of this disease and related problems. The simultaneous use of two drugs in the form of fixed dose combined tablets (FD) in addition to improving patients' compliance with treatment, leads to cost reduction and improvement of symptoms. Dry granulation method was used to make the rapid release layer of solifenacin succinate and polymer composition was used to make the tamsulosin hydrochloride release control layer by wet granulation method. Then the tablets were pressed and coated. Necessary standard tests were performed for all formulations. The results showed that the formulation containing 6 mg of solifenacin succinate and 0.4 mg of tamsulosin hydrochloride was selected as the superior formulation, which is similar to the Vesomni® brand sample.