Vrednotenje sproščanja betametazondipropionata iz dermalne formulacije z difuzijskimi celicami z avtomatiziranim sistemom vzorčenja

Centrih, Ema (author), Gosenca Matjaž, Mirjam (mentor), Vitek, Mercedes (comentor)

Sproščanje zdravilne učinkovine iz formulacije je pomemben vidik v različnih fazah razvoja dermalnih formulacij. Za vrednotenje sproščanja in vitro se pogosto uporabljajo difuzijske celice, pri katerih lahko na rezultate vplivajo številni dejavniki. V okviru diplomske naloge smo preučevali sproščanje modelne zdravilne učinkovine, betametazondipropionata (BDP), iz hidrofilne kreme z uporabo avtomatiziranega sistema Franzovih difuzijskih celic. Sproščanje BDP smo analizirali s tekočinsko kromatografijo visoke ločljivosti. V prvem delu raziskovalnega dela smo določili optimalno sestavo receptorskega medija. Na podlagi rezultatov smo kot najprimernejši receptorski medij za sproščanje BDP izbrali zmes 50 % (v/v) izopropanola in 50 % (v/v) fosfatnega pufra (PBS, pH 7,4), pri kateri smo določili največjo kumulativno maso sproščenega BDP. V hidrofilno kremo smo vgradili BDP v treh različnih deležih (0,64 mg/g, 1,28 mg/g in 2,56 mg/g), ter vrednotili vpliv vsebnosti zdravilne učinkovine, okluzije donorskega dela in hitrosti mešanja receptorskega medija na sproščanje. Med proučevanimi dejavniki se je kot najbolj dosleden izkazal vpliv vsebnosti BDP v formulaciji. Z naraščajočo vsebnostjo BDP se je povečevala tudi njegova kumulativna sproščena masa, pri čemer se je med formulacijami ohranjal vrstni red: krema C (2,56 mg/g) > krema B (1,28 mg/g) > krema A (0,64 mg/g). Vpliv okluzije donorskega dela in hitrosti mešanja receptorskega medija ni bil enoznačen, temveč je bil odvisen od kombinacije uporabljenih eksperimentalnih pogojev. V 24-urnem preskusu pri hitrosti mešanja 900 obratov na minuto z okluzijo se je kumulativna masa sproščenega BDP pri vseh treh formulacijah povečevala skozi celotno obdobje, pri čemer pri nobeni formulaciji nismo opazili jasnega platoja. Rezultati kažejo, da je za ustrezno vrednotenje sproščanja BDP in vitro pomembna optimizacija in nadzor eksperimentalnih pogojev, saj ti omogočajo pridobitev doslednih in ponovljivih rezultatov. Uporaba avtomatiziranega sistema Franzovih difuzijskih celic je omogočila nadzorovano izvedbo preskusov in primerjavo sproščanja BDP pri različnih eksperimentalnih pogojih.

• Language: Slovenian
• Keywords: betametazondipropionat, sproščanje in vitro, Franzove difuzijske celice, dermalne formulacije, eksperimentalni pogoji
• Work type: Bachelor thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2026
• PID: 20.500.12556/RUL-187305
• Publication date in RUL: 10.09.2026

Secondary language

• Language: English
• Title: Evaluation of betamethasone dipropionate release from dermal formulation using diffusion cells with an automated sampling system

Abstract

Drug release from a formulation is an important consideration in various stages of dermal formulation development. Diffusion cells are commonly used for the in vitro evaluation of drug release, with numerous factors potentially affecting the results. In this thesis, the release of the model drug, i.e. betamethasone dipropionate (BDP), from a hydrophilic cream was investigated using an automated Franz diffusion cell system and analysed by high-performance liquid chromatography. In the first part of the experimental work, the optimal composition of the receptor medium was determined. Based on the results, a mixture of 50% (v/v) isopropanol and 50% (v/v) phosphate-buffered saline (PBS, pH 7.4) was selected as the most suitable receptor medium for BDP release, as it resulted in the highest cumulative amount of BDP released. BDP was incorporated into the hydrophilic cream at three different contents (0.64 mg/g, 1.28 mg/g, and 2.56 mg/g), and the effects of drug content, occlusion of the donor compartment, and stirring rate of the receptor medium on BDP release were evaluated. Among the factors investigated, the effect of BDP content in the formulation was the most consistent. As the BDP content increased, the cumulative amount released also increased, with the formulations consistently following the order: cream C (2.56 mg/g) > cream B (1.28 mg/g) > cream A (0.64 mg/g). The effects of donor compartment occlusion and receptor medium stirring rate were not conclusive but rather depended on the combination of experimental conditions used. In the 24-hour study conducted at 900 rpm under occlusive conditions, the cumulative amount of BDP released from all three formulations increased throughout the entire study period, with no clear plateau observed for any of the formulations. The results demonstrate that optimisation and control of experimental conditions are important for the appropriate in vitro evaluation of BDP release, as they enable consistent and reproducible results. The use of an automated Franz diffusion cell system enabled controlled testing and comparison of BDP release under different experimental conditions.

• Keywords: betamethasone dipropionate, in vitro release, Franz diffusion cells, dermal formulations, experimental conditions