Abstract

The study sought to formulate and evaluate suppositories using a locally produced brand of alum (Aw) obtained from bauxite waste generated at Awaso bauxite mine in the Western-North region of Ghana, for use in the treatment of hemorrhoids. The suppositories were formulated using shea butter modified, respectively, with amounts of beeswax and theobroma oil. In another development, theobroma oil was modified with different concentrations of beeswax. Drug-base interactions were investigated using attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy. The suppositories were prepared using the hot melt and trituration methods. Quality control checks were carried out on the formulations. The evaluated parameters included physical characteristics (texture, presence or absence of entrapped air, and contraction holes), weight uniformity, disintegration time, drug content, and in vitro release profile of the alum from the formulated suppositories. An in vivo analysis was carried out on the most suitable formulation to ascertain its efficacy on inflamed tissues using croton oil-induced rectal inflammation in a rat model. A critical examination of the ATR-FTIR spectra revealed no drug-base interactions. The suppository formulations passed all Pharmacopoeia stated tests. The in vivo study revealed the use of suppositories ameliorated the croton oil-induced hemorrhoid in the rectoanal region of the rats.

Highlights

  • Hemorrhoids, called piles, are swollen veins in the anus and lower rectum, similar to varicose veins

  • Since alum has been used in large amounts for the purification of water for human consumption with no noticeable side effects, its use for haemorrhoid treatment will not cause undesirable side effects associated with corticosteroids and NSAIDs. ey can be used for a prolonged period due to the low amount that will be required for treatment

  • (5) Determination of Solubility of Alum in Water. e solubility of the powdered alum (Aw) in water was determined by weighing accurately 65 g into 100 ml of distilled water at 25 C ± 2°C. It was well shaken at time intervals for the first 30 minutes. ey were kept uninterrupted for 2 hours at room temperature. e mixture was filtered and 7.3 ml of the filtrate was diluted to 300 ml. e diluted solution was analyzed by complexometric back titration with ethylenediaminetetraacetic acid (EDTA)

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Summary

Introduction

Hemorrhoids, called piles, are swollen veins in the anus and lower rectum, similar to varicose veins. Pharmacological treatment of haemorrhoid aims at reducing inflammation, pain, and bleeding Topical dosage forms such as creams, ointments, and suppositories containing steroids (corticosteroids) or nonsteroidal anti-inflammatory agents (NSAIDS: ibuprofen, aspirin, and diclofenac), either alone or in combination with antibiotics or anaesthetics (such as lidocaine, benzocaine, and dibucaine), have been shown to be effective. Since alum has been used in large amounts for the purification of water for human consumption with no noticeable side effects, its use for haemorrhoid treatment will not cause undesirable side effects associated with corticosteroids and NSAIDs. ey can be used for a prolonged period due to the low amount that will be required for treatment. Erefore, combinations of these three available bases were evaluated as bases for the formulation of suppositories with locally produced alum. e suppositories were evaluated for quality according to standard specifications and tested for their antihemorrhoidal effect in rat models

Materials and Methods
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