FORMULATION AND EVALUATION OF FAST DISSOLVING HERBAL FILM CONTAINING RESERPINE FOR THE MANAGEMENT OF PULMONARY ARTERIAL HYPERTENSION

Said Salim Said; Nabisere Zulfa; Gokul Bhimajiyan; Chukwuma J. Okafor; Burhani Simai; Sabra Salim Rashid; Abbas S. Ibrahim; Ahmad Makame Mwadini; Harshil Majethia; Prasanna Kumar Desu; Haji Juma Hamisi

doi:10.22270/ujpr.v11i1.1483

Said Salim Said Department of Pharmaceutical Science, Marwadi University, Rajkot, Gujarat, India. Zanzibar Food and Drug Agency (ZFDA), Zanzibar, Tanzania.
Nabisere Zulfa Department of Pharmaceutical Science, Marwadi University, Rajkot, Gujarat, India.
Gokul Bhimajiyan Department of Pharmaceutical Science, Marwadi University, Rajkot, Gujarat, India.
Chukwuma J. Okafor Department of Pathology and Biochemistry, State University of Zanzibar, Tanzania
Burhani Simai Zanzibar Food and Drug Agency (ZFDA), Zanzibar, Tanzania.
Sabra Salim Rashid Medicine Policy Unit, Ministry of Health, Zanzibar, Tanzania.
Abbas S. Ibrahim Department of Pharmacology, State University of Zanzibar, Tanzania.
Ahmad Makame Mwadini Zanzibar Food and Drug Agency (ZFDA), Zanzibar, Tanzania.
Harshil Majethia Department of Pharmaceutical Science, Marwadi University, Rajkot, Gujarat, India.
Prasanna Kumar Desu Department of Pharmaceutical Science, Marwadi University, Rajkot, Gujarat, India.
Haji Juma Hamisi Zanzibar Food and Drug Agency (ZFDA), Zanzibar, Tanzania.

10.22270/ujpr.v11i1.1483

Keywords:

Fast-dissolving films, herbal formulation, pulmonary arterial hypertension, Rauwolfia serpentina, reserpine

Abstract

Background and Objectives: Pulmonary arterial hypertension is a progressive disease of the pulmonary vasculature that is defined by a high pulmonary vascular resistance, which ultimately causes a failure of the right heart. Reserpine is a biologically active compound that is derived from Rauwolfia serpentina. It is known for its potent antihypertensive activity. Therefore, reserpine can be considered a new way of treating pulmonary arterial hypertension. The objectives of the study were to formulate and evaluate the Fast Dissolving Films (FDF) of reserpine using the newly developed polymeric delivery system.

Methods: Reserpine FDFs were prepared using hydroxypropyl methyl cellulose K-15 as the polymeric film former and propylene glycol as the plasticizer using the solvent casting method. Various physicochemical parameters like pH, weight variation, folding endurance, disintegration time, content uniformity, and in vitro dissolution were carried out. Compatibility analysis was carried out using FT-IR. Compatibility between the drug and the polymer was analyzed using Differential Scanning Calorimetry.

Results: These films were transparent, flexible, strong, evenly 0.12-0.17mm thick, with surface pH range compatible with that of the oral cavity (6.0-6.7). The values of folding endurance were above 50 cycles, which shows very strong tensile strength. The disintegration time ranges from 15-66 sec, with the optimized formula (F6) having 97.5% release of the drug in 40 minutes. The DSC scans showed molecular distribution of reserpine with slight reduction of the drug's peak at 63.90°C, thus ensuring the drug is dissolved without degrading to ensure increased bioavailability.

Conclusion: The FTIR spectrogram proves that reserpine is chemically stable in the polymer matrix. Prepared films possess the optimal physico-chemical properties, disintegration times, and dissolution profiles. Hence, the formulation approach demonstrates immense promise for the systemic delivery of the herbal antihypertensive in the treatment of PAH.