Design and Development of Novel Herbal Suppository Formulation for Prostatitis Treatment

Abstract

Background: Prostatitis is a common inflammatory condition of the prostate gland, often treated with antibiotics
and anti-inflammatory drugs, which may have limited efficacy and side effects. Herbal therapies offer
a promising alternative due to their natural anti-inflammatory properties.

Objective: This study aims to design, develop, and evaluate physicochemical, biopharmaceutical and microbiological
properties of novel herbal suppository formulations for the treatment of prostatitis, optimizing their
biopharmaceutical profiles.

Methods: Excipients were selected to form suppositories with herbal ingredients known for their antiinflammatory
effects, specifically lovage, saw palmetto, and calendula CO2 extracts. The formulations were
assessed based on key quality parameters, including organoleptic characteristics, average mass, melting point,
deformation time, disintegration time, microbiological purity, and pH, ensuring compliance with European
Pharmacopoeia (Ph. Eur.) standards. Biopharmaceutical studies compared the release profiles of active compounds
from different suppository bases.

Results: Suppositories based on Witepsol® H15 exhibited satisfactory organoleptic properties, appropriate
melting points, and acceptable deformation and disintegration times. The pH levels were within the required
range, and microbiological tests confirmed purity. Biopharmaceutical evaluations showed that Witepsol®
H15 suppositories had the most appropriate release rates of active compounds compared to those made with
other bases.

Conclusions: The novel herbal suppositories developed in this study show promise for managing prostatitis
based on preliminary evaluations of their physicochemical, microbiological, and biopharmaceutical properties.
Further clinical studies are required to confirm their efficacy and safety.

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Reagents and raw materials

Saw palmetto fruits CO2 extract used for the novel herbal suppository formulation product development was purchased from EUROMED (Spain). Lovage roots CO2 extract and Calendula flowers CO2 extract used for the suppository formulation product development was purchased from FLAVEX Naturextrakte  GmbH  (Germany).  Witepsol® H15 was purchased from IOI Oleo GmbH (Germany), and Suppocire AML from Gattefossé (France), Polyethylene glycol (PEG) 1000, and 6000 from Merck (USA), Polyethylene glycol 4000 (Pluracare® E 4000 Flakes) from BASF (Germany), cocoa but-ter from Cargill (Netherland). Potassium dihydrogen phosphate, sodium chloride, disodium hydrogen phosphate was acquired from Sigma-Aldrich (USA).

O. Golembiovska, O. Dmytrenko, A. Galkin, Design and Development of Novel Herbal Suppository Formulation for Prostatitis Treatment, Innov Biosyst Bioeng, 2024, vol. 8, no. 4, 23–38, Received 15 June 2024; Accepted 20 September 2024, doi: 10.20535/ibb.2024.8.4.317124

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