Herbig ME, Evers D-H, Gorissen S, Köllmer M. Rational design of topical semi-solid dosage forms-how far are we? Pharmaceutics. 2023;15(7):1822. https://doi.org/10.3390/pharmaceutics15071822.
Article CAS PubMed PubMed Central Google Scholar
Viljoen JM, Cowley A, du Preez J, Gerber M, du Plessis J. Penetration enhancing effects of selected natural oils utilized in topical dosage forms. Drug Dev Ind Pharm. 2015;41(12):2045–54. https://doi.org/10.3109/03639045.2015.1047847.
Article CAS PubMed Google Scholar
Walters KA, Roberts MS. Dermatologic, cosmeceutic, and cosmetic development: therapeutic and novel approaches. CRC Press; 2007.
Kocabaş NÖ, Kahraman E, Güngör S. Assessment of membrane type effects on in vitro performance of topical semi-solid products. J Drug Delivery Sci Technol. 2021;64:102646. https://doi.org/10.1016/j.jddst.2021.102646.
Bielfeldt S, Bonnier F, Byrne H, Chourpa I, Dancik Y, Lane ME, Lunter DJ, Munnier E, Puppels G, Tfayli A. Monitoring dermal penetration and permeation kinetics of topical products; the role of Raman microspectroscopy. TrAC, Trends Anal Chem. 2022;156:116709.
Leal LB, Cordery SF, Delgado-Charro MB, Bunge AL, Guy RH. Bioequivalence methodologies for topical drug products: in vitro and ex vivo studies with a corticosteroid and an anti-fungal drug. Pharm Res. 2017;34(4):730–7. https://doi.org/10.1007/s11095-017-2099-1.
Article CAS PubMed PubMed Central Google Scholar
Singh S, Govind M, Bothara SB. A review on in vitro—in vivo mucoadhesive strength assessment. PhaTechMed. 2013;2:221–9.
Singh S, Bothara SB, Patel DR, Naveen MK. Formulation and ex-vivo evaluation of transdermal patches of glipizide using the penetration enhancer Buchanania-Lanzan (Spreng) seed oil. Int J Pharmaceutical Sci Nanotechnol (IJPSN). 2015;8(1):2768–74.
Ontong JC, Singh S, Nwabor OF, Chusri S, Voravuthikunchai SP. Potential of antimicrobial topical gel with synthesized biogenic silver nanoparticle using Rhodomyrtus tomentosa leaf extract and silk sericin. Biotech Lett. 2020;42(12):2653–64. https://doi.org/10.1007/s10529-020-02971-5.
Raghavan L, Brown M, Michniak-Kohn B, Ng S, Sammeta S. In vitro release tests as a critical quality attribute in topical product development. In: Langley N, Michniak-Kohn B, Osborne DW (eds) The role of microstructure in topical drug product development. Springer International Publishing, Cham, 2019; pp 47–87. https://doi.org/10.1007/978-3-030-17355-5_2
Rath S, Kanfer I. A validated IVRT method to assess topical creams containing metronidazole using a novel approach. Pharmaceutics. 2020;12(2):119. https://doi.org/10.3390/pharmaceutics12020119.
Article CAS PubMed PubMed Central Google Scholar
Miron DS, Rădulescu FS, Voicu VA, Mînea A, Cardot J-M, Shah VP. Rheological and in vitro release measurements of manufactured acyclovir 5% creams: confirming sensitivity of the in vitro release. Pharm Dev Technol. 2021;26(7):779–87. https://doi.org/10.1080/10837450.2021.1945625.
Article CAS PubMed Google Scholar
Quartier J, Capony N, Lapteva M, Kalia YN. Cutaneous biodistribution: a high-resolution methodology to assess bioequivalence in topical skin delivery. Pharmaceutics. 2019;11(9):484. https://doi.org/10.3390/pharmaceutics11090484.
Article CAS PubMed PubMed Central Google Scholar
Milanowski B, Wosicka-Frąckowiak H, Główka E, Sosnowska M, Woźny S, Stachowiak F, Suchenek A, Wilkowski D. Optimization and evaluation of the in vitro permeation parameters of topical products with non-steroidal anti-inflammatory drugs through Strat-M(®) membrane. Pharmaceutics. 2021;13(8):1305. https://doi.org/10.3390/pharmaceutics13081305.
Article CAS PubMed PubMed Central Google Scholar
Samadder A, Bhattacharjee B, Dey S, Chakrovorty A, Dey R, Sow P, Tarafdar D, Biswas M, Nandi S. Enhanced drug carriage efficiency of curcumin-loaded PLGA nanoparticles in combating diabetic nephropathy via mitigation of renal apoptosis. J Pharmacopuncture. 2024;27(1):1.
Article PubMed PubMed Central Google Scholar
Miranda M, Veloso C, Brown M, Pais AACC, Cardoso C, Vitorino C. Topical bioequivalence: experimental and regulatory considerations following formulation complexity. Int J Pharmaceutics. 2022;620:121705. https://doi.org/10.1016/j.ijpharm.2022.121705.
Kulkarni M, Potdar S, Date AA, Marfatiya A. In vitro release testing of acyclovir topical formulations using immersion cells. Assay Drug Dev Technol. 2020;19(2):75–84. https://doi.org/10.1089/adt.2020.995.
Article CAS PubMed Google Scholar
Tiffner KI, Kanfer I, Augustin T, Raml R, Raney SG, Sinner F. Comparative in vitro release testing (IVRT) of acyclovir products. Int J Pharm. 2021;609:121186. https://doi.org/10.1016/j.ijpharm.2021.121186.
Article CAS PubMed Google Scholar
Kleinbeck KR, Bader RA, Kao WJ. Concurrent in vitro release of silver sulfadiazine and bupivacaine from semi-interpenetrating networks for wound management. J Burn Care Res. 2009;30(1):98–104. https://doi.org/10.1097/BCR.0b013e3181921ed9.
Kyriacos SB, Boukarim C, Safi W, Mroueh M, Maroun AB, El-Khoury G, Shehayeb R. In vitro testing of ciprofloxacin formulations and preliminary study on BCS biowaiver. J Food Drug Anal. 2009;17(2):10.
Farol LT, Hymes KB. Bexarotene: a clinical review. Expert Rev Anticancer Ther. 2004;4(2):180–8.
Article CAS PubMed Google Scholar
Sammour RMF, Khan G, Sameer S, Khan S, Zohair T, Saraya S, Abdul Rasool BK. Development of clindamycin loaded oral microsponges (Clindasponges) for antimicrobial enhancement: in vitro characterization and simulated in vivo studies. Biol Pharm Bull. 2023;46(8):1088–97. https://doi.org/10.1248/bpb.b23-00099.
Article CAS PubMed Google Scholar
Dréno B, Bettoli V, Ochsendorf F, Layton AM, Perez M, Dakovic R, Gollnick H. Efficacy and safety of clindamycin phosphate 1.2%/tretinoin 0.025% formulation for the treatment of acne vulgaris: pooled analysis of data from three randomised, double-blind, parallel-group, phase III studies. Eur J Dermatol. 2014;24:201–9.
Fantini A, Demurtas A, Nicoli S, Padula C, Pescina S, Santi P. In vitro skin retention of crisaborole after topical application. Pharmaceutics. 2020;12(6):491. https://doi.org/10.3390/pharmaceutics12060491.
Article CAS PubMed PubMed Central Google Scholar
Roy S, Das SK, Pal M, Gupta BK. Design and in vitro evaluation of dapsone-loaded micropellets of ethyl cellulose. Pharm Res. 1989;6(11):945–8. https://doi.org/10.1023/A:1015989328550.
Article CAS PubMed Google Scholar
Sanz R, Clares B, Mallandrich M, Casals I, Bellido D, Calpena A. Validation of doxepin quantitative determination methods for their application to in vitro, ex vivo and in vivo studies. Curr Pharmaceutical Anal. 2015;11(4):269–77.
Lu M, Xiong D, Sun W, Yu T, Hu Z, Ding J, Cai Y, Yang S, Pan B. Sustained release ivermectin-loaded solid lipid dispersion for subcutaneous delivery: in vitro and in vivo evaluation. Drug Delivery. 2017;24(1):622–31.
Article CAS PubMed PubMed Central Google Scholar
Thakker KD, Chern WH. Development and validation of in vitro release tests for semisolid dosage forms-case study. Dissolut Technol. 2003;10(2):10–6.
Kulkarni M, Potdar S, Date AA, Marfatiya A. In vitro release testing of acyclovir topical formulations using immersion cells. Assay Drug Dev Technol. 2021;19(2):75–84.
Article CAS PubMed PubMed Central Google Scholar
Externbrink A. Investigating the feasibility of accelerated drug release testing for intravaginal rings. 2014. https://epub.ub.uni-greifswald.de/frontdoor/deliver/index/docId/1369/file/diss_externbrink_anna.pdf.
Thakker K, Klein R. Chapter 19 - Drug release: topical products. In: Christopher M. Riley, Thomas W. Rosanske, George Reid, editors. Specification of Drug Substances and Products. 2nd ed. Elsevier; 2020. pp. 505–534. https://doi.org/10.1016/B978-0-08-102824-7.00019-1.
ICH guidlines. https://www.ich.org/page/quality-guidelines. Accessed 10 October 2023
Miranda M, Cova T, Augusto C, Pais AACC, Cardoso C, Vitorino C. Diving into batch-to-batch variability of topical products-a regulatory bottleneck. Pharm Res. 2020;37(11):218. https://d
Comments (0)