The substantiation for the selection of excipients in the composition of the topical analgesic foam
Skin aerosol foams are promising drug delivery systems due to their numerous advantages and ease of use. The application of foam minimizes the need for touching and rubbing the damaged skin, as the foam spreads easily on the skin with minimal to moderate shear force, which is particularly beneficial for treating wounds of various etiologies. Numerous scientific studies have demonstrated that the pharmaceutical combination of dexpanthenol and lidocaine creates an effective formulation for treating skin conditions due to their anti-inflammatory, antipruritic, anesthetic, and antiseptic properties. The aim of the study was to justify the selection of excipients in the composition of topical analgesic foam to ensure its stability, effectiveness, ease of application, and therapeutic properties. Results and Discussion The composition of a topical analgesic foam containing dexpanthenol at a concentration of 50 mg/ml and lidocaine hydrochloride at 15 mg/ml was developed and justified. A technological process for manufacturing the foam was proposed. The use of excipients, including solvents, plasticizers, foam boosters, and foam stability stabilizers, was characterized, ensuring the formation of stable foam. The compatibility of aerosol solution components with the propellant was studied under various storage temperatures (2–8°C, 25°C, 37°C). The results confirm that the developed foam composition meets pharmacopoeial requirements for stability, efficacy, and consumer properties. This allows recommending the developed formulation for further research and practical application. Conclusions Optimal concentrations of excipients and propellant were justified to ensure appropriate consumer properties. It was determined that a propane-butane content in the range of 33.25–35.0 g provides optimal foam delivery characteristics, including stability (up to 40 minutes) and a high release percentage (over 93%). The pH of the primary solution (5.1–5.5) corresponds to the optimal range for the skin (4–6.5), ensuring patient comfort, minimizing irritation, and promoting wound healing processes. Further studies are aimed at the biopharmaceutical evaluation of the dosage form.
Authors
- М. Е. Попова (ORCID: https://orcid.org/0000-0002-2579-0331)
- О. О. Салій (ORCID: https://orcid.org/0000-0001-7103-2083)
- V. V. Strashnyi (ORCID: https://orcid.org/0000-0002-9188-1821)
- A. R. Tovstiga
Publication Details
- Journal
- News of pharmacy
- Published
- 2025-03-17
- DOI
- https://doi.org/10.24959/nphj.25.160
- Primary Topic
- Intramuscular injections and effects
- Type
- article
- Field-Weighted Citation Impact
- 0.00