Optimization of Gel Cream Containing HAMIN™ and HPMC K100M as Bases for Topical Delivery of Diclofenac Sodium
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Submitted
30 July 2025
Published
30 March 2026
Keywords:
-
Gel cream, HAMIN™, HPMC K100M, Optimization, Simplex Lattice Design
Abstract
Diclofenac sodium, a widely used NSAID, has limited skin permeability, which reduces its topical efficacy; therefore, a gel-cream formulation combining the rapid absorption of gels with the emollient properties of creams is proposed to enhance drug penetration and patient comfort. To further improve delivery, HAMIN™, a novel natural palm oil–based base with excellent biocompatibility and lipid-enhancing properties, will be combined with HPMC K100M. This thickener stabilises viscosity and prolongs skin contact time, supporting better absorption. This study aimed to develop and optimise a topical gel cream for diclofenac sodium using HAMIN™ and HPMC K100M to achieve ideal physical properties and improved skin penetration. The formulation was statistically optimised using a Simplex Lattice Design (SLD), with HAMIN™ (X1) and HPMC K100M (X2) as independent variables, and pH (Y1), spreadability (Y2), viscosity (Y3), extrudability (Y4), release flux (Y5), and permeation flux (Y6) as dependent responses. Optimisation with Design Expert version 13 yielded the ideal composition of 16.84% HAMIN™ and 1.16% HPMC K100M, resulting in predicted values of pH 5.07, spreadability 7 cm, viscosity 4502.25 mPas, extrudability 78.98 N/s, release flux 70.61 µg/cm2/minute, and permeation flux 0.4868 µg/cm2/minute, with a desirability score of 0.829. Despite a slightly lower release flux, the optimised HAMIN™ and HPMC K100M-based gel cream demonstrated superior skin permeation compared to a commercial emulgel for up to 300 minutes. The incorporation of HAMIN™, a natural palm oil base, offers a novel and effective strategy to enhance the topical delivery of diclofenac sodium via a statistically optimised gel cream formulation.
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References
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2. Winarti L, Gazzali AM, Arafika WW, Ameliana L, Ulfa EU, Nurahmanto D, et al. Optimization study on palm fat base (HAMIN®) and purified water proportion in diphenhydramine hydrochloride cream formulation. Pharmaciana. 2025;15(2):264-74. DOI: 10.12928/pharmaciana.v15i2.30790
3. Chylińska N, Maciejczyk M. Hyaluronic Acid and Skin: Its Role in Aging and Wound-Healing Processes. Gels. 2025;11(4):281. DOI: 10.3390/gels11040281. PMID: 40277717; PMCID: PMC12026949.
4. Goon DE, Kadir SHSA, Ab Latip N, Ab Rahim S, Mazlan M. Palm Oil in Lipid-Based Formulations and Drug Delivery Systems. Biomolecules. 2019;9(2):64. DOI: 10.3390/biom9020064. PMID: 30781901; PMCID: PMC6406477.
5. Strati F, Neubert RHH, Opálka L, Kerth A, Brezesinski G. Non-ionic surfactants as innovative skin penetration enhancers: insight in the mechanism of interaction with simple 2D stratum corneum model system. Eur J Pharm Sci. 2021;157:105620. DOI: 10.1016/j.ejps.2020.105620. PMID: 33122012.
6. Kasparaviciene G, Maslii Y, Herbina N, Kazlauskiene D, Marksa M, Bernatoniene J. Development and Evaluation of Two-Phase Gel Formulations for Enhanced Delivery of Active Ingredients: Sodium Diclofenac and Camphor. Pharmaceutics. 2024;16(3):366. DOI: 10.3390/pharmaceutics16030366. PMID: 38543261; PMCID: PMC10974502.
7. Pârvănescu R, Trandafirescu C, Musuc AM, Ozon EA, Culita DC, Mitran RA, et al. Comparative Physicochemical and Pharmacotechnical Evaluation of Three Topical Gel-Cream Formulations. Gels. 2025;11(7):532. DOI: 10.3390/gels11070532. PMID: 40710694; PMCID: PMC12295134.
8. Vlad RA, Pintea A, Pintea C, Rédai EM, Antonoaea P, Bîrsan M, et al. Hydroxypropyl Methylcellulose-A Key Excipient in Pharmaceutical Drug Delivery Systems. Pharmaceutics. 2025;17(6):784. DOI: 10.3390/pharmaceutics17060784. PMID: 40574096; PMCID: PMC12196896.
9. Chopra L, Thakur KK, Chohan JS, Sharma S, Ilyas RA, Asyraf MRM, et al. Comparative Drug Release Investigations for Diclofenac Sodium Drug (DS) by Chitosan-Based Grafted and Crosslinked Copolymers. Materials. 2022;15(7):2404. DOI: 10.3390/ma15072404. PMID: 35407737; PMCID: PMC9000032.
10. Khodari SNK, Noordin MI, Chan L, Chik Z. In vitro and in vivo Evaluation of New Topical Anaesthetic Cream Formulated with Palm Oil Base. Curr Drug Deliv. 2017;14(5):690-5. DOI: 10.2174/1567201813666160801113302. PMID: 27480118.
11. Haron DEM, Chik Z, Noordin MI, Mohamed Z. In vitro and in vivo evaluation of a novel testosterone transdermal delivery system (TTDS) using palm oil base. Iran J Basic Med Sci. 2015;18(12):1167-75. PMID: 26877845; PMCID: PMC4744355.
12. Pauna AR, Tartau LM, Vasilescu AM, Abu Koush A, Stan RT, Moraru MC, et al. Assessment of the Anti-Inflammatory Effectiveness of Diclofenac Encapsulated in Chitosan-Coated Lipid Microvesicles in Rats. Pharmaceutics. 2025;17(5):607. DOI: 10.3390/pharmaceutics17050607. PMID: 40430898; PMCID: PMC12115328.
13. Pradal J, Vallet CM, Frappin G, Bariguian F, Lombardi MS. Importance of the formulation in the skin delivery of topical diclofenac: not all topical diclofenac formulations are the same. J Pain Res. 2019;12:1149-54. DOI: 10.2147/JPR.S191300. PMID: 31114298; PMCID: PMC6489664.
14. Jadiya S, Upmanyu N, Sathiyanarayanan A, Jain V, Dubey R, Buwade P. Formulation and Development of Novel Sulfasalazine Bilayer Tablets for The Treatment of Arthritis Associated With IBD: In-vitro and In-vivo Investigations. J Pharm Sci. 2024;113(7):1919-26. DOI: 10.1016/j.xphs.2024.02.019. PMID: 38401631.
15. Fukase H, Futagami S, Yamamoto T, Masaoka T, Terahara T, Okawa K, et al. Investigation of the effects of a new transdermal formulation of systemic diclofenac on the upper gastrointestinal mucosa in patients with low back pain: A comparative study with oral diclofenac. J Gastroenterol Hepatol. 2024;39(12):2504-10. DOI: 10.1111/jgh.16810. PMID: 39592167; PMCID: PMC11660207.
16. Nayak A, Mandal SK, Ramadan MA, Rath SK. Formulation, Development and Physicochemical Characterization of Diclofenac Topical Emulgel. Egypt J Chem. 2021;64(3):1563-73. DOI: 10.21608/ejchem.2021.58467.3259
17. Thakur NL, Praween SN. In-Vitro Evaluation of Diclofenac Sodium Gel. Int J Pharm Sci. 2025;3(9):3667–84. DOI: 10.5281/zenodo.17235413
18. Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products (Volume 4). 2nd Edition. New York: Informa Healthcare, Inc; 2009. DOI: 10.1201/9781315102856
19. Pradal J, Vallet CM, Frappin G, Bariguian F, Lombardi MS. Importance of the formulation in the skin delivery of topical diclofenac: not all topical diclofenac formulations are the same. J Pain Res. 2019;12:1149-54. DOI: 10.2147/jpr.s191300; PMID: 31114298; PMCID: PMC6489664.
20. Hirun N, Kraisit P, Santhan S, Kittiwisut S, Poonsawas P. Development of a Water-in-Oil Microemulsion Template for Chitosan Nanogel Fabrication via Genipin Crosslinking. Polymers (Basel). 2026;18(4):473. DOI: 10.3390/polym18040473; PMID: 41754662; PMCID: PMC12944439.
21. Rothman JS, Borges-Merjane C, Holderith N, Jonas P, Silver RA. Validation of a stereological method for estimating particle size and density from 2D projections with high accuracy. PLoS One. 2023;18(3):e0277148. DOI: 10.1371/journal.pone.0277148; PMID: 36930689; PMCID: PMC10022809.
22. Preeti, Sambhakar S, Malik R, Bhatia S, Al Harrasi A, Rani C, et al. Nanoemulsion: An Emerging Novel Technology for Improving the Bioavailability of Drugs. Scientifica. 2023;2023:6640103. DOI: 10.1155/2023/6640103; PMID: 37928749; PMCID: PMC10625491.
23. Duan S, Yu L, Dong J, Du Z, Liu S, Yin H, et al. Biomimetic Fermentation Reshapes Precursor Pools to Drive Synergistic Roasting Reactions and Enhance Coffee Flavor Complexity. Foods. 2026;15(5):849. DOI: 10.3390/foods15050849; PMID: 41829125; PMCID: PMC12984349.
24. Djuwarno EN, Hiola F, Isa I. Formulasi Sediaan Emulgel Ekstrak Daun Kelor (Moringa oleifera Lam) Dan Uji Aktivitas Antioksidan Menggunakan Metode DPPh. Indones J Pharm Educ. 2021;1(1):10-9. DOI: 10.37311/ijpe.v1i1.9947
25. Parwati P, Wikantyasning ER. Optimisation of Cream Formulation Containing Peperomia pellucida Leaf Extract and Chitosan Nanoparticles. Trop J Nat Prod Res. 2023;7(11):5183–7. DOI: 10.26538/tjnpr/v7i11.22
26. Al-Barghouthy EY, Hamed S, Mehyar GF, AlKhatib HS. Comparative Evaluation of Spreadability Measurement Methods for Topical Semisolid Formulations/A Scoping Review. Gels. 2025;11(12):1006. DOI: 10.3390/gels11121006; PMID: 41441162; PMCID: PMC12732428.
27. Ugandar RE, Deivi KS. Formulation and Evaluation of Natural Palm Oil-Based Vanishing Cream. Int J Pharm Sci Res. 2013;4(9):3375-80. DOI: 10.13040/IJPSR.0975-8232.4(9).3375-80
28. Medina JR, Cortes M, Romo E. Comparison of the USP Apparatus 2 and 4 for testing the in vitro release performance of ibuprofen generic suspensions. Int J Appl Pharm. 2017;9(4):90-5. DOI: 10.22159/ijap.2017v9i4.19926
29. Bolla PK, Clark BA, Juluri A, Cheruvu HS, Renukuntla J. Evaluation of Formulation Parameters on Permeation of Ibuprofen from Topical Formulations Using Strat-M® Membrane. Pharmaceutics. 2020;12(2):151. DOI: 10.3390/pharmaceutics12020151; PMID: 32069850; PMCID: PMC7076669.
30. Ashok M, Habibuddin M, Raju J. Provesicular Based Colloidal Carriers for Transdermal Drug Delivery: Formulation Aspects and Bioavailability Enhancement of Acyclovir Proliposomal Gels. Int J Pharm Investig. 2021;11(2):195–203. DOI: 10.5530/ijpi.2021.2.35.
31. Dandagi PM, Pandey P, Gadad AP, Mastiholimath VS. Formulation and evaluation of microemulsion-based luliconazole gel for topical delivery. Indian J Pharm Educ Res. 2020;54(2):293–301. DOI: 10.5530/ijper.54.2.34.
32. Manian M, Jain P, Vora D, Banga AK. Formulation and Evaluation of the In Vitro Performance of Topical Dermatological Products Containing Diclofenac Sodium. Pharmaceutics. 2022;14(9):1892. DOI: 10.3390/pharmaceutics14091892; PMID: 36145640; PMCID: PMC9502351.
33. Vlad RA, Pintea A, Pintea C, Rédai EM, Antonoaea P, Bîrsan M, et al. Hydroxypropyl Methylcellulose-A Key Excipient in Pharmaceutical Drug Delivery Systems. Pharmaceutics. 2025;17(6):784. doi: 10.3390/pharmaceutics17060784; PMID: 40574096; PMCID: PMC12196896.
34. Teo MZY, Loo HL, Goh BH, Chuah LH. Progress in topical nanoformulations against bacterial skin and soft tissue infections- current trends. Drug Deliv Transl Res. 2025;15(11):4141-86. DOI: 10.1007/s13346-025-01924-7; PMID: 40681833; PMCID: PMC12508018.
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Authors
1.
Winarti L, Gazzali AM, Mufidah FM, Faramayuda F, Ulfa EU, Nurahmanto D, Afthoni MH, Pratiwi L, Wijianto B. Optimization of Gel Cream Containing HAMIN™ and HPMC K100M as Bases for Topical Delivery of Diclofenac Sodium. Borneo J Pharm [Internet]. 2026Mar.30 [cited 2026Jun.14];9(1):35-47. Available from: https://journal.umpr.ac.id/index.php/bjop/article/view/10417
Copyright (c) 2026 Lina Winarti, Amirah Mohd Gazzali, Fania Mufti Mufidah, Fahrauk Faramayuda, Evi Umayah Ulfa, Dwi Nurahmanto, Muhammad Hilmi Afthoni, Liza Pratiwi, Bambang Wijianto
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