References
- Vila J, Hebert AA, Torrelo A, et al. Ozenoxacin: a review of preclinical and clinical efficacy. Expert Rev Anti Infect Ther. 2019;17(3):159–168 doi: 10.1080/14787210.2019.1573671.
- Davino G, D'Alvano T, Esposito S. The use of ozenoxacin in pediatric patients: clinical evidence, efficacy and safety. Front Pharmacol. 2020;11:559708. doi: 10.3389/fphar.2020.559708.
- Gattefosse. 2022. [last accessed Mar 21, 2022]. Available from: https://www.gattefosse.com/pharmaceuticals-products/labrafil-m-1944-cs
- Gattefosse. 2022. [last accessed Mar 21, 2022]. Available from: https://www.gattefosse.com/pharmaceuticals-products/tefose-63
- XEPI. 2022. [last accessed Mar 13, 2022]. Available from: https://www.xepicream.com/resources/full-prescribing-information.
- OZANEX. 2022. [last accessed Sep 25, 2022]. Available from: https://www.cipherpharma.com/wp-content/uploads/2017/12/Ozanex-PM-English.pdf
- Burki IK, Khan MK, Khan BA, et al. Formulation development, characterization, and evaluation of a novel Dexibuprofen-Capsaicin skin emulgel with improved in vivo anti-inflammatory and analgesic effects. AAPS PharmSciTech. 2020;21(6):211. doi: 10.1208/s12249-020-01760-7.
- Pinheiro IM, Carvalho IPS, Neto JAT, et al. Amphotericin B-loaded emulgel: effect of chemical enhancers on the release profile and antileishmanial activity in vitro. AAPS PharmSciTech. 2019;20(3):122. doi: 10.1208/s12249-019-1323-1.
- Han HS, Koo SY, Choi KY. Emerging nanoformulation strategies for phytocompounds and applications from drug delivery to phototherapy to imaging. Bioact Mater. 2021;14:182–205.
- Latif MS, Nawaz A, Asmari M, et al. Formulation development and in vitro/in vivo characterization of Methotrexate-Loaded nanoemulsion gel formulations for enhanced topical delivery. Gels. 2022;9(1):3. doi: 10.3390/gels9010003.
- Miron DS, Rădulescu FȘ, Voicu VA, et al. Are European marketed acyclovir 5% cream products similar? Comparison with EU and US reference product. Drug Dev Ind Pharm. 2021;47(6):990–1000. doi: 10.1080/03639045.2021.1957921.
- Shah VP, Elkins J, Schuirman D, et al. Application of in vitro release methods to assure product performance of semisolid dosage forms before and after certain post-approval changes. Dissolution Technol. 1998;5(3):5–11. doi: 10.14227/DT050398P5.
- U.S. Food and Drug Administration Guidance for Industry: nonsterile semisolid dosage forms: scale-up and post-approval changes: chemistry, manufacturing, and controls; in vitro release testing and in vivo bioequivalence documentation. SUPAC-SS CMC 7. 1997. [last accessed Mar 13, 2022]. Available from: https://www.fda.gov/media/71141/download
- Miron DS, Rădulescu FȘ, Voicu VA, et al. Rheological and in vitro release measurements of manufactured acyclovir 5% creams: confirming sensitivity of the in vitro release. Pharm Dev Technol. 2021;26(7):779–787. doi: 10.1080/10837450.2021.1945625.
- Da Silva JD, Gomes MV, Cabral LM, et al. Evaluation of the in vitro release and permeation of cordia verbenacea DC essential oil from topical dosage forms. J Drug Deliv Sci Technol. 2019;53:101173. doi: 10.1016/j.jddst.2019.101173.
- Madhur K, Shrikant P, Abhijit AD, et al. In vitro release testing of acyclovir topical formulations using immersion cells. ASSAY Drug Dev Technol. 2021;19(2):75–84.
- Rath S, Kanfer I. A validated IVRT method to assess topical creams containing metronidazole using a novel approach. Pharmaceutics. 2020;12(2):119. doi: 10.3390/pharmaceutics12020119.
- Committee for Medicinal Products for Human Use, EMA. Draft guideline on quality and equivalence of topical products. CHMP/QWP/708282/2018, EMA. 2018. [last accessed Aug 30, 2022]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-equivalence-topical-products_en.pdf
- Draft product specific guidance on acyclovir ointment. Guidance for industry. FDA; 2022. [last accessed Oct 30, 2022]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018604.pdf
- Draft product specific guidance on acyclovir cream. Guidance for industry. FDA; 2022. [last accessed Oct 30, 2022]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021478.pdf
- Draft product specific guidance on ozenoxacin cream. Guidance for industry. FDA; 2022. [last accessed Oct 30, 2022]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208945.pdf
- Validation of analytical procedures: text and methodology Q2 (R1). ICH. 2022. [last accessed Mar 13, 2022]. Available from: https://www.ich.org/page/quality-guidelines
- Amarnath Reddy R, Kumar D. B. Analytical method validation on simultaneous estimation of ozenoxacin and benzoic acid in pharmaceutical formulation. Acta Chromatogr. 2022;35(3):278–285.
- Tarragó C, Santos B, Raga M, et al. Inventor; ferrer international, S.A., assignee. pharmaceutical topical compositions. United States patent US 9,180,200 B2. 2015 Nov 10.
- Tarragó C, Santos B, Raga M, et al. Inventor; ferrer international, S.A., assignee. pharmaceutical topical compositions. United States patent US 9,399,014 B2. 2016 Jul 26.
- US FDA Orange Book. 2022. [last accessed Mar 13, 2022]. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
- USP general chapter < 1724> semisolid drug products-performance tests. Rockville (MD): United States Pharmacopoeia and National Formulary. USP36-NF31; 2013. p. 5778–5788.
- Gattefosse. 2022. [last accessed Mar 21, 2022]. Available from: https://www.gattefosse.com/pharmaceuticals-products/transcutol-p
- Higuchi T. Rate of release of medicaments from ointment bases containing drugs in suspension. J Pharm Sci. 1961;50(10):874–875. doi: 10.1002/jps.2600501018.
- Pillai R, Shah V, Abriola L, et al. Release of hydrocortisone from a cream matrix: dependency of release on suspension concentration and measurement of solubility and diffusivity. Pharm Dev Technol. 2001;6(3):373–384. doi: 10.1081/pdt-100002619.
- Siepmann J, Peppas NA. Higuchi equation: derivation, applications, use and misuse. Int J Pharm. 2011;418(1):6–12. doi: 10.1016/j.ijpharm.2011.03.051.
- Reviewer guidance, validation of chromatographic methods. FDA; 1994. [last accessed Mar 13, 2022]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reviewer-guidance-validation-chromatographic-methods
- Sharma N, Madan P, Lin S. Effect of process and formulation variables on the preparation of parenteral paclitaxel-loaded biodegradable polymeric nanoparticles: a co-surfactant study. Asian J Pharm Sci. 2016;11(3):404–416. doi: 10.1016/j.ajps.2015.09.004.
- Sindi AM, Hosny KM, Rizg WY, et al. Utilization of experimental design in the formulation and optimization of hyaluronic acid–based nanoemulgel loaded with a turmeric–curry leaf oil nanoemulsion for gingivitis. Drug Deliv. 2023;30(1):2184311. doi: 10.1080/10717544.2023.2184311.
- Pavoni L, Perinelli DR, Bonacucina G, et al. An overview of micro- and nanoemulsions as vehicles for essential oils: formulation, preparation and stability. Nanomaterials (Basel). 2020;10(1):135. doi: 10.3390/nano10010135.
- Hosny KM, Alhakamy NA, Sindi AM, et al. Coconut oil nanoemulsion loaded with a statin hypolipidemic drug for management of burns: formulation and in vivo evaluation. Pharmaceutics. 2020;12(11):1061. doi: 10.3390/pharmaceutics12111061.
- Rizg WY, Hosny KM, Elgebaly SS, et al. Preparation and optimization of garlic oil/apple cider vinegar nanoemulsion loaded with minoxidil to treat alopecia. Pharmaceutics. 2021;13(12):2150. doi: 10.3390/pharmaceutics13122150.
- Pradhan M, Singh D, Singh MR. Influence of selected variables on fabrication of triamcinolone acetonide loaded solid lipid nanoparticles for topical treatment of dermal disorders. Artif Cells Nanomed Biotechnol. 2016;44(1):392–400. doi: 10.3109/21691401.2014.955105.
- Fernández-Campos F, Obach M, Moreno MC, et al. Pharmaceutical development of a generic corticoid semisolid formulation. J Drug Deliv Sci Technol. 2017;42:227–236. doi: 10.1016/j.jddst.2017.03.016.
- Li C, Liu C, Liu J, et al. Correlation between rheological properties, in vitro release, and percutaneous permeation of tetrahydropalmatine. AAPS PharmSciTech. 2011;12(3):1002–1010. doi: 10.1208/s12249-011-9664-4.
- Amplitude sweeps. [last accessed Apr 01, 2023]. Available from: https://wiki.anton-paar.com/in-en/amplitude-sweeps/
- Flow curve and yield point determination with rotational viscometry. [last accessed Apr 01, 2023]. Available from: https://wiki.anton-paar.com/in-en/flow-curve-and-yield-point-determination-with-rotational-viscometry/
- Santos B, Ortiz J, Gropper S. In vitro percutaneous absorption and metabolism of ozenoxacin in excised human skin. Future Microbiol. 2014;9(8): s 3–S9. doi: 10.2217/fmb.14.81.
- Tiffner KI, Kanfer I, Augustin T, et al. A comprehensive approach to qualify and validate the essential parameters of an in vitro release test (IVRT) method for acyclovir cream, 5%. Int J Pharm. 2018;535(1–2):217–227. doi: 10.1016/j.ijpharm.2017.09.049.
- Higuchi WI. Analysis of data on the medicament release from ointments. J Pharm Sci. 1962;51(8):802–804. doi: 10.1002/jps.2600510825.
- Raghavan L, Brown M, Michniak-Kohn B, et al. In vitro release tests as a critical quality attribute in topical product development. In: Langley N, Michniak-Kohn B, Osborne DW, editors. The role of microstructure in topical drug product development. AAPS advances in the pharmaceutical sciences series. Cham, Switzerland: Springer.; 2019. p. 47–87.
- Rawat A, Gupta SS, Kalluri H, et al. Rheological characterization in the development of topical drug products. In: Langley N, Michniak-Kohn B, Osborne DW, editors. The role of microstructure in topical drug product development. AAPS advances in the pharmaceutical sciences series. Cham, Switzerland: Springer.; 2019. p. 3–45.
- Wilson RJ, Li Y, Yang G, et al. Nanoemulsions for drug delivery. Particuology. 2022;64:85–97. doi: 10.1016/j.partic.2021.05.009.
- Mura S, Manconi M, Valenti D, et al. Transcutol containing vesicles for topical delivery of minoxidil. J Drug Target. 2011;19(3):189–196. doi: 10.3109/1061186X.2010.483516.
- Chen H, Chang X, Du D, et al. Microemulsion-based hydrogel formulation of ibuprofen for topical delivery. Int J Pharm. 2006;315(1–2):52–58. doi: 10.1016/j.ijpharm.2006.02.015.
- Osborne DW, Musakhanian J. Skin penetration and permeation properties of transcutol®-neat or diluted mixtures. AAPS PharmSciTech. 2018;19(8):3512–3533. doi: 10.1208/s12249-018-1196-8.