Procena stabilnosti emulzionih preparata za topikalnu primenu: vrednost dinamičko-mehaničkog termoanalitičkog (DMTA) testa kao brze reološke alternative konvencionalnom testu smrzavanje-odmrzavanje

  • Nebojša Cekić Univerzitet u Nišu – Tehnološki fakultet u Leskovcu; DCP Hemigal, Sektor za istraživanje i razvoj
  • Sanela Savić Univerzitet u Nišu – Tehnološki fakultet u Leskovcu; DCP Hemigal, Sektor za istraživanje i razvoj
  • Snežana Savić Univerzitet u Beogradu – Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju
Ključne reči: emulzije za kožu, fizička stabilnost, ubrzano ispitivanje stabilnosti, reološki testovi, rok upotrebe

Sažetak


Procena stabilnosti emulzionih preparata za topikalnu primenu može se sprovesti praćenjem promena u realnom vremenu i/ili primenom ubrzanih metoda, te predviđanjem stabilnosti i roka trajanja proizvoda na osnovu merenja relevantnih fizičkohemijskih parametara tokom ispitivanja. Kako bi se obezbedila robusnost i dugoročnost emulzionih proizvoda za kožu tokom čuvanja, transporta i primene, neophodno je sprovesti pažljivo isplanirano, opsežno ispitivanje stabilnosti. Međutim, imajući u vidu različite tipove emulzija i njihovu namenu, ne postoji univerzalni standardni protokol za ispitivanje stabilnosti, što formulatore/proizvođača čini odgovornim kada je u pitanju izbor odgovarajućeg testa i metodologije. Evidentno je da emulzije za topikalnu primenu, a posebno kozmetičke emulzije, često pokazuju visoku stabilnost sa dugim rokovima upotrebe. S druge strane, procena stabilnosti ovakvih emulzija i donošenje odgovarajućih odluka i dalje ostaje izazov u industrijskom okruženju i zahteva dosta vremena, što nameće potrebu za alternativnim protokolima koji omogućavaju ubrzano ispitivanje, ali i uspešno predviđanje stabilnosti emulzionih proizvoda. Prikazani rad daje sveobuhvatni pregled literature prožet praktičnim pogledima na ključne fenomene odgovorne za stabilnost emulzija, zatim daje uvid u različite pristupe za procenu njihove stabilnosti, uključujući metodologije koje se koriste i parametre koji se prate tokom ispitivanja. Rad u poseban fokus stavlja dinamičko-mehanički termoanalitički (DMTA) metod kao brzu reološku alternativu konvencionalnom testu smrzavanje-odmrzavanje, posebno ističući primenljivost metoda za ubrzano ispitivanje stabilnosti emulzionih preparata za topikalnu primenu.

Reference

Merriam-Webster's Collegiate Dictionary. 11th ed. Springfield, Massachussets: Merriam-Webster Inc.; 2004. 1623 p.

Matthews BR. Regulatory aspects of stability testing in Europe. Drug Dev Ind Pharm. 1999;25(7):831-56.

Cekic ND, Savic SM, Savic SD. Dynamic-mechanical thermoanalysis test: a rapid alternative for accelerated freeze-thaw stability evaluation of W/O emulsions. Drug Dev Ind Pharm. 2019;45(12):1896-906.

International Organisation for Standardisation (ISO). ISO/TR 13097:2013(en) – Guidelines for the characterization of dispersion stability. 2013.

International Organisation for Standardisation (ISO). ISO/TR 18811:2018(en) – Cosmetics — Guidelines on the stability testing of cosmetic products. 2018.

International Federation of Societies of Cosmetic Chemists (IFSCC). The fundamentals of stability testing (IFSCC Monograph No. 2). Weymouth: Micelle Press; 1992.

Badolato GG, Aguilar F, Schuchmann HP, Sobisch T, Lerche D. Evaluation of long term stability of model emulsions by multisample analytical centrifugation. In: Auernhammer GK, Butt HJ, Vollmer D, editors. Surface and interfacial forces – from fundamentals to applications. Progress in Colloid and Polymer Science; vol 134. Berlin, Heidelberg: Springer; 2008.

Lerche D, Sobisch T. Direct and Accelerated Characterization of Formulation Stability. Journal of Dispersion Science and Technology. 2011;32(12):1799-811.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Harmonised Tripartite Guideline Q1A (R2): Stability testing of new drug substances and products. 2003.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Guideline Q1B: Stability testing: Photostability testing of new drug substances and products. 1996.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Guideline Q1C: Stability testing for new dosage forms. 1996.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Guideline Q1D: Bracketing and matrixing designs for stability testing of new drug substances and products. 2002.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Guideline Q1E: Evaluation of stability data. 2003.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Guideline Q1F: Stability data package for registration applications in climatic zones III and IV. 2006.

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. 2009 (current consolidated version: 16/08/2023).

Cosmetics Europe. Guidelines on stability testing of cosmetic products. 2004.

Cekic ND, Savic SM, Savic SD. Dynamic-mechanical thermoanalysis test as a high-performance alternative for accelerated freeze-thaw stability testing: a case study of O/W emulsions. Drug Dev Ind Pharm. 2020;46(3):505-20.

Huynh-Ba K. Handbook of stability testing in pharmaceutical development: regulations, methodologies, and best practices. New York: Springer; 2008. 389 p.

Baertschi SW, Alsante KM, Tønnesen HH. A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision. J Pharm Sci. 2010;99(7):2934-40.

Rieger MM. Stability testing of macroemulsions. Cosmetics and toiletries. 1991;106:59-69.

ANVISA National Health Surveillance Agency. ANVISA Cosmetics Products Stability Guide. Quality in Cosmetic Series. 2004.

Mezger T. The Rheology Handbook. Hannover: Vincentz Network; 2020. 528 p.

Lee H, Jin M, Jeon W-J, Kim H, Jung M, Yoo H, et al. Regulatory and safe-use considerations related to stability after opening of nonsterile dosage forms. J Pharm Investig. 2022;52(3):319-29.

Chavda H. In-use stability studies: guidelines and challenges. Drug Dev Ind Pharm. 2021;47(9):1373-91.

European Medicines Agency (EMA). Note for Guidance on in-use stability testing of human medicinal products. 2001.

World Health Organization (WHO). TRS 1010 – Annex 10: WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products. WHO Technical Report Series 1010, 2018.

Particle Sciences – Drug Development Services. Emulsion stability and testing. Technical Brief; vol. 2. 2011.

Tadros TF. Flocculation of emulsions. In: Tadros TF, editor. Emulsions: formulation, stability, industrial applications. Berlin/Boston: Walter de Gruyter GmbH; 2016; p. 113-28.

Tadros TF. Ostwald ripening in emulsions and its prevention. In: Tadros TF, editor. Emulsions: formulation, stability, industrial applications. Berlin/Boston: Walter de Gruyter GmbH; 2016; p. 129-40.

Tadros TF. Phase inversion and its prevention. In: Tadros TF, editor. Emulsions: formulation, stability, industrial applications. Berlin/Boston: Walter de Gruyter GmbH; 2016; p. 161-72.

Aoki T, Decker EA, McClements DJ. Influence of environmental stresses on stability of O/W emulsions containing droplets stabilized by multilayered membranes produced by a layer-by-layer electrostatic deposition technique. Food Hydrocolloids. 2005;19(2):209-20.

Ghosh S, Coupland JN. Factors affecting the freeze–thaw stability of emulsions. Food Hydrocolloids. 2008;22(1):105-11.

Tadros TF. Characterization of emulsions and assessment of their stability. In: Tadros TF, editor. Emulsions: formulation, stability, industrial applications. Berlin/Boston: Walter de Gruyter GmbH; 2016; p. 173-96.

Klang V, Valenta C. Lecithin-based nanoemulsions. J Drug Deliv Sci Technol. 2011;21(1):55-76.

Masmoudi H, Dréau YL, Piccerelle P, Kister J. The evaluation of cosmetic and pharmaceutical emulsions aging process using classical techniques and a new method: FTIR. Int J Pharm. 2005;289(1-2):117-31.

Mcclements DJ. Critical review of techniques and methodologies for characterization of emulsion stability. Crit Rev Food Sci Nutr. 2007;47(7):611-49.

Zografi G. Physical stability assessment of emulsions and related disperse systems: a critical review. J Soc Cosmet Chem. 1982;33:345-58.

Alade OS, Mahmoud M, Al Shehri DA, Sultan AS. Rapid determination of emulsion stability using turbidity measurement incorporating artificial neural network (ann): experimental validation using video/optical microscopy and kinetic modeling. ACS Omega. 2021;6(8):5910-20.

Bernardi DS, Pereira TA, Maciel NR, Bortoloto J, Viera GS, Oliveira GC, et al. Formation and stability of oil-in-water nanoemulsions containing rice bran oil: in vitro and in vivo assessments. J Nanobiotechnology. 2011;9:44.

Đorđević SM, Radulović TS, Cekić ND, Ranđelović DV, Savić MM, Krajišnik DR, et al. Experimental design in formulation of diazepam nanoemulsions: physicochemical and pharmacokinetic performances. J Pharm Sci. 2013;102(11):4159-72.

Mitri K, Shegokar R, Gohla S, Anselmi C, Müller RH. Lipid nanocarriers for dermal delivery of lutein: preparation, characterization, stability and performance. Int J Pharm. 2011;414(1-2):267-75.

Isailović T, Ðorđević S, Marković B, Ranđelović D, Cekić N, Lukić M, et al. Biocompatible nanoemulsions for improved aceclofenac skin delivery: formulation approach using combined mixture-process experimental design. J Pharm Sci. 2016;105(1):308-23.

Savic SM, Cekic ND, Savic SR, Ilic TM, Savic SD. 'All-natural' anti-wrinkle emulsion serum with Acmella oleracea extract: A design of experiments (DoE) formulation approach, rheology and in vivo skin performance/efficacy evaluation. Int J Cosmet Sci. 2021;43(5):530-546.

Objavljeno
2023/10/27
Rubrika
Pregledni (Revijalni) rad