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Formulation and evaluation of emulgel containing Sucralfate and Dimethicone; A novel transdermal pharmaceutical dosage form

Yıl 2022, Cilt: 26 Sayı: 5, 1125 - 1137, 28.06.2025

Öz

Considering the lack of oxygen, prolonged pressure, and infection are common features of most chronic
wounds, especially in pressure ulcers, finding a way to heal the wounds at the early stages is essential. Various
pharmaceutical dosage forms are used to act against the infection and prevent the development of this painful condition.
The present study aimed to prepare and evaluate topical emulgel formulation for use in the treatment of patients with
grade I and II bedsore. The formulation was prepared through the oil in water (o/w) emulsion of organic and aqueous
parts to prepare a depot for the transfer of the hydrophobic drug. Emulgel contains sucralfate (Suc), as the epidermal
growth factor (EGF) and basic fibroblast growth factor (bFGF) could increase the wound healing rate in these patients.
The results showed that the emulgel was stable, homogenous non-discolored, and had a constant pH. In terms of
microbial content, it was within the acceptable range of pharmacopeia, and the preservatives had a suitable performance.
The product had good spreadability. Rheological studies demonstrated that the prepared formulation had thixotropic
properties, which is one of the most critical indicators in the design of semi-solid pharmaceutical forms. Topical emulgel
containing Suc can be used as an effective pharmaceutical dosage form to treat grade I and II bedsore due to its
innovative pharmacological form and the benefits of this drug form along with the moisturizing, softening, and
protecting properties of dimethicone and unique properties of Suc.

Kaynakça

  • [1] Headlam J, Illsley A. Pressure ulcers: an overview. Br J Hosp Med (Lond). 2020;81(12):1-9. [CrossRef]
  • [2] Velnar T, Bailey T, Smrkolj V. The wound healing process: an overview of the cellular and molecular mechanisms. J Int Med Res. 2009;37(5):1528-1542. [CrossRef]
  • [3] Song YP, Shen HW, Cai JY, Zha ML, Chen HL. The relationship between pressure injury complication and mortality risk of older patients in follow‐up: a systematic review and meta‐analysis. Int Wound J. 2019;16(6):1533- 1544. [CrossRef]
  • [4] Rehman K, Zulfakar MH. Recent advances in gel technologies for topical and transdermal drug delivery. Drug Dev Ind Pharm. 2014;40(4):433-440. [CrossRef]
  • [5] V.S S. An Overview on Emulgel. Int J Pharm Phytopharm Res. February 2019;9(1):92-97. [CrossRef]
  • [6] Ajazuddin, Alexander A, Khichariya A, Gupta S, Patel RJ, Giri TK, et al. Recent expansions in an emergent novel drug delivery technology: Emulgel. J Control Release. 2013;171(2):122-132. [CrossRef]
  • [7] Gupta PJ, Heda PS, Shrirao SA, Kalaskar SS. Topical sucralfate treatment of anal fistulotomy wounds: a randomized placebo-controlled trial. Dis Colon Rectum. 2011;54(6):699-704. [CrossRef]
  • [8] Ochi K. Chemistry of Sucralfate. In: Hollander D, Tytgat G, editors. Sucralfate From Basic Science to the Bedside. New York: Chugai Pharmaceutical Co. Ltd. Plenum Medical Book Company is an imprint of Plenum Publishing Corporation; 1995. pp. 47-58. [CrossRef]
  • [9] McCARTHY D. Sucralfate. N Engl J Med. 325(14):1017-1025. [CrossRef]
  • [10] Vafaei M, Derakhashani S, Elahi B. Modified retention enema, possible cure for solitary rectal ulcer. Irn J Med Hypotheses Ideas. 2007;1(5):1-15. [CrossRef]
  • [11] Masuelli L, Tumino G, Turriziani M, Modesti A, Bei R. Topical Use of Sucralfate in Epithelial Wound Healing: Clinical Evidence and Molecular Mechanisms of Action. Recent Pat Inflamm Allergy Drug Discov. 2010;4:25-36. [CrossRef]
  • [12] Volkin DB, Verticelli AM, Marfia KE, Burke CJ, Mach H, Middaugh CR. Sucralfate and soluble sucrose octasulfate bind and stabilize acidic fibroblast growth factor. Biochim Biophys Acta. 1993;1203:18-26. [CrossRef]
  • [13] Tumino G, Masuelli L, Bei R, Simonelli L, Santoro A, Francipane S. Topical treatment of chronic venous ulcers with sucralfate: A placebo controlled randomized study. Int J Mol Med. 2008;22(1):17-23. [CrossRef]
  • [14] Hollander D. Efficacy of sucralfate for duodenal ulcers: a multicenter, double-blind trial. J Clin Gastroenterol. 1981;3(Suppl 2):153-157. [CrossRef]
  • [15] Alquraini M, Alshamsi F, Møller MH, Belley-Cote E, Almenawer S, Jaeschke R, et al. Sucralfate Versus Histamine 2 Receptor Antagonists for Stress Ulcer Prophylaxis in Adult Critically Ill Patients: A Meta-analysis and Trial Sequential Analysis of Randomized Trials. J Crit Care. 2017;40:21-30. [CrossRef]
  • [16] Kouloulias V, Asimakopoulos C, Tolia M, Filippou G, Platoni K, Dilvoi M, et al. Sucralfate gel as a radioprotector against radiation induced dermatitis in a hypo-fractionated schedule: a non-randomized study. Hippokratia. 2013;17(2):126-129. [CrossRef]
  • [17] Saha A, Chattopadhyay S, Azam M, Sur PK. The role of honey in healing of bedsores in cancer patients. South Asian J Cancer. 2012;1(2):66-71. [CrossRef]
  • [18] McDONALD A, LESAGE P. Palliative Management of Pressure Ulcers and Malignant Wounds in Patients with Advanced Illness. J Palliat Med. 2006;9(2):285-295. [CrossRef]
  • [19] Banati A, Chowdhury SR, Mazumder S. Topical use of Sucralfate Cream in second and third degree burns. Burns. 2001;27(5):465–469. [CrossRef]
  • [20] Rattan J, Schneider M, Arber N, Gorsky M, Dayan D. Sucralfate suspension as a treatment of recurrent aphthous stomatitis. J Intern Med. 1994;236:341-343. [CrossRef]
  • [21] Hassanzadeh G, Hajmanouchehri F, roi AB, Hassanzadeh N, Shafigh N, Barzroudipour M, et al. Comparing Effects of Silver sulfadiazine, Sucralfate and Brassica oleracea extract on Burn Wound Healing. Life Sci J. 2013;10(6s):852- 861. [CrossRef]
  • [22] Konturek SJ, Konturek JW, Brzozowski T, Slomiany BL, Slomiany A. Effects of Sucralfate on Growth Factor Availability. In: Hollander D, Tytgat G, editors. Sucralfate From Basic Science to the Bedside. New York: Chugai Pharmaceutical Co. Ltd. Plenum Medical Book Company is an imprint of Plenum Publishing Corporation; 1995. p. 175-189. [CrossRef]
  • [23] Kumar D, Singh J, Antil M, Kumar V. Emulgel-Novel Topical Drug Delivery System -A Comprehensive Review. Int J Pharm Sci Res.2016;7(12):4733-4742. [CrossRef]
  • [24] Marshall P. Product stability and stability testing. 2018. In: Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. Elsevier. Fifth Edition. [862-83].
  • [25] Kaur LP, Guleri TK. Topical Gel: A Recent Approach for Novel Drug delivery: Review Article. Asian J Biomed Pharm Sci. 2013;3(17):1-5. [CrossRef]
  • [26] Ueda CT, Shah VP, Derdzinski K, Ewing G, Flynn G, Maibac H, et al. Topical and Transdermal Drug Products. Pharmacopeial Forum. 2009;35(3):750-764. [CrossRef]
  • [27] Schmid-Wendtner M-H, Korting HC. The pH of the Skin Surface and Its Impact on the Barrier Function. Skin Pharmacol Physiol. 2006;19(6):296-302. [CrossRef]
  • [28] Nair A, Jacob S, Al-Dhubiab B, Attimarad M, Harsha S. Basic considerations in the dermatokinetics of topical formulations. Braz J Pharm Sci. 2013;49(3):423-434. [CrossRef]
  • [29] Joshua S. Boateng , Kerr H. Matthews , Howard N.E. Stevens, Eccleston GM. Wound Healing Dressings and Drug Delivery Systems: A Review. J Pharm Sci. 2008;97(8):2892-2923. [CrossRef]
  • [30] <3> Topical and Transdermal Drug Products-Product Quality Tests. USP. Interim Revision Announcement edNovember 1, 2013.
  • [31] Pinheiro IM, Carvalho IPS, Neto JAT, Lopes GLN, de Sousa Coêlho E, Sobrinho-Júnior EPC, et al. Amphotericin Bloaded emulgel: effect of chemical enhancers on the release profile and antileishmanial activity in vitro. AAPS PharmSciTech. 2019;20(3):1-8. [CrossRef]
  • [32] Ghica MV, Hîrjău M, Lupuleasa D, Dinu-Pîrvu C-E. Flow and Thixotropic Parameters for Rheological Characterization of Hydrogels. Molecules. 2016;21(786):1-17. [CrossRef]
  • [33] Benchabane A, Bekkour K. Rheological properties of carboxymethyl cellulose (CMC) solutions. Colloid Polym Sci. 2008;286(10):1173-1180. [CrossRef]
  • [34] Kittipongpatana OS, Burapadaja S, Kittipongpatana N. Carboxymethyl mungbean starch as a new pharmaceutical gelling agent for topical preparation. Drug Dev Ind Pharm. 2009;35(1):34-42. [CrossRef]
  • [35] Moghimipour E, Kouchak M, Salimi A, Bahrampour S, Handali S. The effect of polymer content on the nonnewtonian behavior of acetaminophen suspension. J Drug Deliv. 2013:907471-907476. [CrossRef]
  • [36] Marriott C. Scientific principles of dosage form design: <6>Rheology. In: Aulton ME, Taylor KMG, editors. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. Fifth Edition ed: Elsevier; 2018. p. 93-113.
  • [37] Chow KT, Chan LW, Heng PWS. Characterization of Spreadability of Nonaqueous Ethylcellulose Gel Matrices Using Dynamic Contact Angle. J Pharm Sci. 2008;97(8):3467-3482. [CrossRef]
  • [38] Navaneetha K, Asma B, Sumalatha P, Vinita D, Sravan J, Chinnala M. Formulation and in-vitro evaluation of capsaicin emulgel for topical delivery. Scholars Acad J Pharm. 2017;6(6):281-287. [CrossRef]
  • [39] Burki IK, Khan MK, Khan BA, Uzair B, Braga VA, Jamil QA. 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):1-14. [CrossRef]
  • [40] Thakur NK, Bharti P, Mahant S, Rao R. Formulation and Characterization of Benzoyl Peroxide Gellified Emulsions. Sci Pharm. 2012;80(4):1045-1060. [CrossRef]
  • [41] USFaD A. Pharmaceutical Microbiology Manual. 2014.
  • [42] <51> Antimicrobial Effectiveness Testing / Microbiological Tests. USP2012.
  • [43] <1111>Microbiological Quality of Non-sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. USP. 33(2). Second Interim Revision Announcemen ed11/21/2016.
  • [44] <61>: Microbiological Examination Of Nonsterile Products: Microbial Enumerattion Tests. USP. 34(6). Sixth Interim Revision Announcement ed11/21/2016.
  • [45] Grove G, Houser T, Zerweck C. A Comparison of the Effectiveness and Wash-Off Resistance of four Dimethicone Skin Barrier Creams 3M Skin & Wound Care Division. J Wound Ostomy Continence Nurs. 2010:1-6. [CrossRef]
  • [46] Handbook of Pharmaceutical Excipients. Sixth Edition ed. London. Chicago: Pharmaceutical Press (PhP); 2009. 888 p.
  • [47] Shahin M, Hady SA, Hammad M, Mortada N. Novel Jojoba Oil-Based Emulsion Gel Formulations for Clotrimazole Delivery. AAPS PharmSciTech. 2011;12(1):239-247. [CrossRef]
  • [48] Sagiri SS, Singh VK, Mallick PS, Anis A. Thermal, Mechanical and Electrochemical Characterization of Gelatin- Based Physical Emulgels. Int J Electrochem Sci. 2015;10:1233-1248.
  • [49] Gadhave A. Determination of hydrophilic-lipophilic balance value. Int J Sci Res. 2014;3(4):573-575.
  • [50] ICI Americas i. The HLB system : a time saving guide to emulsifier selection. Rev ed: Wilmington : ICI Americas, Inc; 1984.
  • [51] Samy AM, Ramadan AA, El-Enin ASMA, Mortagi YIM. Formulation and optimization of itraconazole proniosomes using box behnken design. Int J App Pharm. 2018;10(2):41-51.
  • [52] Das SR, Panigrahi BB, Pani MK. Formulation and evaluation of sucralfate and metoprolol succinate bi-layer floating tablet as gastro retentive drug delivery system world journal of pharmaceutical and medical research. wjpmr. 2019;5(1):241-258.
  • [53] ASEAN Guideline on Stability Study of Drug Product (R1) 2013.
  • [54] (CPMP) CfPMP. Guidline on Stability Testing: Stability Testing of Existing Ative Substances and Related Finished Products. London: European Medicines Agency Inspections; 17 December 2003.
  • [55] Annex 10: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-second report ed2018. p. 313-314.
  • [56] Burki IK, Khan MK, Khan BA, Uzair B, Braga VA, Jamil QA. 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. [CrossRef]
  • [57] Khullar R, Kumar D, Seth N, Saini S. Formulation and evaluation of mefenamic acid emulgel for topical delivery. Saudi Pharm J. 2012;20(1):63-7. [CrossRef]
  • [58] Shadab M, Shamsi S. Design and Development of Unani Emulgel for Vitiligo. J Ayurveda Integr Med. 2020;11(3):199-205. [CrossRef]
  • [59] Bhalekar MR, Madgulkar AR, Kadam GJ. Evaluation of gelling agents for clindamycin phosphate gel. World J Pharm Pharm Sci. 2015;4(07):2022-2033.
  • [60] 3.3.1 Microbiological Examination of Non-sterile Products: Microbial Enumeration. The International Pharmacopoeia. Ninth Edition ed2019.
  • [61] 3.3.2 Tests for specified microorganisms. The International Pharmacopoeia. Ninth Edition ed2019.
  • [62] Fahelelbom KMS, El-Shabrawy YS. Analysis of preservatives in pharmaceutical products. Pharm Rev. 2007;5(1):1- 55. [CrossRef]
Yıl 2022, Cilt: 26 Sayı: 5, 1125 - 1137, 28.06.2025

Öz

Kaynakça

  • [1] Headlam J, Illsley A. Pressure ulcers: an overview. Br J Hosp Med (Lond). 2020;81(12):1-9. [CrossRef]
  • [2] Velnar T, Bailey T, Smrkolj V. The wound healing process: an overview of the cellular and molecular mechanisms. J Int Med Res. 2009;37(5):1528-1542. [CrossRef]
  • [3] Song YP, Shen HW, Cai JY, Zha ML, Chen HL. The relationship between pressure injury complication and mortality risk of older patients in follow‐up: a systematic review and meta‐analysis. Int Wound J. 2019;16(6):1533- 1544. [CrossRef]
  • [4] Rehman K, Zulfakar MH. Recent advances in gel technologies for topical and transdermal drug delivery. Drug Dev Ind Pharm. 2014;40(4):433-440. [CrossRef]
  • [5] V.S S. An Overview on Emulgel. Int J Pharm Phytopharm Res. February 2019;9(1):92-97. [CrossRef]
  • [6] Ajazuddin, Alexander A, Khichariya A, Gupta S, Patel RJ, Giri TK, et al. Recent expansions in an emergent novel drug delivery technology: Emulgel. J Control Release. 2013;171(2):122-132. [CrossRef]
  • [7] Gupta PJ, Heda PS, Shrirao SA, Kalaskar SS. Topical sucralfate treatment of anal fistulotomy wounds: a randomized placebo-controlled trial. Dis Colon Rectum. 2011;54(6):699-704. [CrossRef]
  • [8] Ochi K. Chemistry of Sucralfate. In: Hollander D, Tytgat G, editors. Sucralfate From Basic Science to the Bedside. New York: Chugai Pharmaceutical Co. Ltd. Plenum Medical Book Company is an imprint of Plenum Publishing Corporation; 1995. pp. 47-58. [CrossRef]
  • [9] McCARTHY D. Sucralfate. N Engl J Med. 325(14):1017-1025. [CrossRef]
  • [10] Vafaei M, Derakhashani S, Elahi B. Modified retention enema, possible cure for solitary rectal ulcer. Irn J Med Hypotheses Ideas. 2007;1(5):1-15. [CrossRef]
  • [11] Masuelli L, Tumino G, Turriziani M, Modesti A, Bei R. Topical Use of Sucralfate in Epithelial Wound Healing: Clinical Evidence and Molecular Mechanisms of Action. Recent Pat Inflamm Allergy Drug Discov. 2010;4:25-36. [CrossRef]
  • [12] Volkin DB, Verticelli AM, Marfia KE, Burke CJ, Mach H, Middaugh CR. Sucralfate and soluble sucrose octasulfate bind and stabilize acidic fibroblast growth factor. Biochim Biophys Acta. 1993;1203:18-26. [CrossRef]
  • [13] Tumino G, Masuelli L, Bei R, Simonelli L, Santoro A, Francipane S. Topical treatment of chronic venous ulcers with sucralfate: A placebo controlled randomized study. Int J Mol Med. 2008;22(1):17-23. [CrossRef]
  • [14] Hollander D. Efficacy of sucralfate for duodenal ulcers: a multicenter, double-blind trial. J Clin Gastroenterol. 1981;3(Suppl 2):153-157. [CrossRef]
  • [15] Alquraini M, Alshamsi F, Møller MH, Belley-Cote E, Almenawer S, Jaeschke R, et al. Sucralfate Versus Histamine 2 Receptor Antagonists for Stress Ulcer Prophylaxis in Adult Critically Ill Patients: A Meta-analysis and Trial Sequential Analysis of Randomized Trials. J Crit Care. 2017;40:21-30. [CrossRef]
  • [16] Kouloulias V, Asimakopoulos C, Tolia M, Filippou G, Platoni K, Dilvoi M, et al. Sucralfate gel as a radioprotector against radiation induced dermatitis in a hypo-fractionated schedule: a non-randomized study. Hippokratia. 2013;17(2):126-129. [CrossRef]
  • [17] Saha A, Chattopadhyay S, Azam M, Sur PK. The role of honey in healing of bedsores in cancer patients. South Asian J Cancer. 2012;1(2):66-71. [CrossRef]
  • [18] McDONALD A, LESAGE P. Palliative Management of Pressure Ulcers and Malignant Wounds in Patients with Advanced Illness. J Palliat Med. 2006;9(2):285-295. [CrossRef]
  • [19] Banati A, Chowdhury SR, Mazumder S. Topical use of Sucralfate Cream in second and third degree burns. Burns. 2001;27(5):465–469. [CrossRef]
  • [20] Rattan J, Schneider M, Arber N, Gorsky M, Dayan D. Sucralfate suspension as a treatment of recurrent aphthous stomatitis. J Intern Med. 1994;236:341-343. [CrossRef]
  • [21] Hassanzadeh G, Hajmanouchehri F, roi AB, Hassanzadeh N, Shafigh N, Barzroudipour M, et al. Comparing Effects of Silver sulfadiazine, Sucralfate and Brassica oleracea extract on Burn Wound Healing. Life Sci J. 2013;10(6s):852- 861. [CrossRef]
  • [22] Konturek SJ, Konturek JW, Brzozowski T, Slomiany BL, Slomiany A. Effects of Sucralfate on Growth Factor Availability. In: Hollander D, Tytgat G, editors. Sucralfate From Basic Science to the Bedside. New York: Chugai Pharmaceutical Co. Ltd. Plenum Medical Book Company is an imprint of Plenum Publishing Corporation; 1995. p. 175-189. [CrossRef]
  • [23] Kumar D, Singh J, Antil M, Kumar V. Emulgel-Novel Topical Drug Delivery System -A Comprehensive Review. Int J Pharm Sci Res.2016;7(12):4733-4742. [CrossRef]
  • [24] Marshall P. Product stability and stability testing. 2018. In: Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. Elsevier. Fifth Edition. [862-83].
  • [25] Kaur LP, Guleri TK. Topical Gel: A Recent Approach for Novel Drug delivery: Review Article. Asian J Biomed Pharm Sci. 2013;3(17):1-5. [CrossRef]
  • [26] Ueda CT, Shah VP, Derdzinski K, Ewing G, Flynn G, Maibac H, et al. Topical and Transdermal Drug Products. Pharmacopeial Forum. 2009;35(3):750-764. [CrossRef]
  • [27] Schmid-Wendtner M-H, Korting HC. The pH of the Skin Surface and Its Impact on the Barrier Function. Skin Pharmacol Physiol. 2006;19(6):296-302. [CrossRef]
  • [28] Nair A, Jacob S, Al-Dhubiab B, Attimarad M, Harsha S. Basic considerations in the dermatokinetics of topical formulations. Braz J Pharm Sci. 2013;49(3):423-434. [CrossRef]
  • [29] Joshua S. Boateng , Kerr H. Matthews , Howard N.E. Stevens, Eccleston GM. Wound Healing Dressings and Drug Delivery Systems: A Review. J Pharm Sci. 2008;97(8):2892-2923. [CrossRef]
  • [30] <3> Topical and Transdermal Drug Products-Product Quality Tests. USP. Interim Revision Announcement edNovember 1, 2013.
  • [31] Pinheiro IM, Carvalho IPS, Neto JAT, Lopes GLN, de Sousa Coêlho E, Sobrinho-Júnior EPC, et al. Amphotericin Bloaded emulgel: effect of chemical enhancers on the release profile and antileishmanial activity in vitro. AAPS PharmSciTech. 2019;20(3):1-8. [CrossRef]
  • [32] Ghica MV, Hîrjău M, Lupuleasa D, Dinu-Pîrvu C-E. Flow and Thixotropic Parameters for Rheological Characterization of Hydrogels. Molecules. 2016;21(786):1-17. [CrossRef]
  • [33] Benchabane A, Bekkour K. Rheological properties of carboxymethyl cellulose (CMC) solutions. Colloid Polym Sci. 2008;286(10):1173-1180. [CrossRef]
  • [34] Kittipongpatana OS, Burapadaja S, Kittipongpatana N. Carboxymethyl mungbean starch as a new pharmaceutical gelling agent for topical preparation. Drug Dev Ind Pharm. 2009;35(1):34-42. [CrossRef]
  • [35] Moghimipour E, Kouchak M, Salimi A, Bahrampour S, Handali S. The effect of polymer content on the nonnewtonian behavior of acetaminophen suspension. J Drug Deliv. 2013:907471-907476. [CrossRef]
  • [36] Marriott C. Scientific principles of dosage form design: <6>Rheology. In: Aulton ME, Taylor KMG, editors. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. Fifth Edition ed: Elsevier; 2018. p. 93-113.
  • [37] Chow KT, Chan LW, Heng PWS. Characterization of Spreadability of Nonaqueous Ethylcellulose Gel Matrices Using Dynamic Contact Angle. J Pharm Sci. 2008;97(8):3467-3482. [CrossRef]
  • [38] Navaneetha K, Asma B, Sumalatha P, Vinita D, Sravan J, Chinnala M. Formulation and in-vitro evaluation of capsaicin emulgel for topical delivery. Scholars Acad J Pharm. 2017;6(6):281-287. [CrossRef]
  • [39] Burki IK, Khan MK, Khan BA, Uzair B, Braga VA, Jamil QA. 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):1-14. [CrossRef]
  • [40] Thakur NK, Bharti P, Mahant S, Rao R. Formulation and Characterization of Benzoyl Peroxide Gellified Emulsions. Sci Pharm. 2012;80(4):1045-1060. [CrossRef]
  • [41] USFaD A. Pharmaceutical Microbiology Manual. 2014.
  • [42] <51> Antimicrobial Effectiveness Testing / Microbiological Tests. USP2012.
  • [43] <1111>Microbiological Quality of Non-sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. USP. 33(2). Second Interim Revision Announcemen ed11/21/2016.
  • [44] <61>: Microbiological Examination Of Nonsterile Products: Microbial Enumerattion Tests. USP. 34(6). Sixth Interim Revision Announcement ed11/21/2016.
  • [45] Grove G, Houser T, Zerweck C. A Comparison of the Effectiveness and Wash-Off Resistance of four Dimethicone Skin Barrier Creams 3M Skin & Wound Care Division. J Wound Ostomy Continence Nurs. 2010:1-6. [CrossRef]
  • [46] Handbook of Pharmaceutical Excipients. Sixth Edition ed. London. Chicago: Pharmaceutical Press (PhP); 2009. 888 p.
  • [47] Shahin M, Hady SA, Hammad M, Mortada N. Novel Jojoba Oil-Based Emulsion Gel Formulations for Clotrimazole Delivery. AAPS PharmSciTech. 2011;12(1):239-247. [CrossRef]
  • [48] Sagiri SS, Singh VK, Mallick PS, Anis A. Thermal, Mechanical and Electrochemical Characterization of Gelatin- Based Physical Emulgels. Int J Electrochem Sci. 2015;10:1233-1248.
  • [49] Gadhave A. Determination of hydrophilic-lipophilic balance value. Int J Sci Res. 2014;3(4):573-575.
  • [50] ICI Americas i. The HLB system : a time saving guide to emulsifier selection. Rev ed: Wilmington : ICI Americas, Inc; 1984.
  • [51] Samy AM, Ramadan AA, El-Enin ASMA, Mortagi YIM. Formulation and optimization of itraconazole proniosomes using box behnken design. Int J App Pharm. 2018;10(2):41-51.
  • [52] Das SR, Panigrahi BB, Pani MK. Formulation and evaluation of sucralfate and metoprolol succinate bi-layer floating tablet as gastro retentive drug delivery system world journal of pharmaceutical and medical research. wjpmr. 2019;5(1):241-258.
  • [53] ASEAN Guideline on Stability Study of Drug Product (R1) 2013.
  • [54] (CPMP) CfPMP. Guidline on Stability Testing: Stability Testing of Existing Ative Substances and Related Finished Products. London: European Medicines Agency Inspections; 17 December 2003.
  • [55] Annex 10: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fifty-second report ed2018. p. 313-314.
  • [56] Burki IK, Khan MK, Khan BA, Uzair B, Braga VA, Jamil QA. 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. [CrossRef]
  • [57] Khullar R, Kumar D, Seth N, Saini S. Formulation and evaluation of mefenamic acid emulgel for topical delivery. Saudi Pharm J. 2012;20(1):63-7. [CrossRef]
  • [58] Shadab M, Shamsi S. Design and Development of Unani Emulgel for Vitiligo. J Ayurveda Integr Med. 2020;11(3):199-205. [CrossRef]
  • [59] Bhalekar MR, Madgulkar AR, Kadam GJ. Evaluation of gelling agents for clindamycin phosphate gel. World J Pharm Pharm Sci. 2015;4(07):2022-2033.
  • [60] 3.3.1 Microbiological Examination of Non-sterile Products: Microbial Enumeration. The International Pharmacopoeia. Ninth Edition ed2019.
  • [61] 3.3.2 Tests for specified microorganisms. The International Pharmacopoeia. Ninth Edition ed2019.
  • [62] Fahelelbom KMS, El-Shabrawy YS. Analysis of preservatives in pharmaceutical products. Pharm Rev. 2007;5(1):1- 55. [CrossRef]
Toplam 62 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Eczacılık Bilimleri
Bölüm Articles
Yazarlar

Farnia Ghanbarveisi 0000-0002-7813-6405

Zahra Pourmanouchehri 0000-0001-6484-3224

Salar Khaledian 0000-0003-2161-9200

Leila Behbood 0000-0002-6769-9181

Yayımlanma Tarihi 28 Haziran 2025
Yayımlandığı Sayı Yıl 2022 Cilt: 26 Sayı: 5

Kaynak Göster

APA Ghanbarveisi, F., Pourmanouchehri, Z., Khaledian, S., Behbood, L. (2025). Formulation and evaluation of emulgel containing Sucralfate and Dimethicone; A novel transdermal pharmaceutical dosage form. Journal of Research in Pharmacy, 26(5), 1125-1137.
AMA Ghanbarveisi F, Pourmanouchehri Z, Khaledian S, Behbood L. Formulation and evaluation of emulgel containing Sucralfate and Dimethicone; A novel transdermal pharmaceutical dosage form. J. Res. Pharm. Haziran 2025;26(5):1125-1137.
Chicago Ghanbarveisi, Farnia, Zahra Pourmanouchehri, Salar Khaledian, ve Leila Behbood. “Formulation and Evaluation of Emulgel Containing Sucralfate and Dimethicone; A Novel Transdermal Pharmaceutical Dosage Form”. Journal of Research in Pharmacy 26, sy. 5 (Haziran 2025): 1125-37.
EndNote Ghanbarveisi F, Pourmanouchehri Z, Khaledian S, Behbood L (01 Haziran 2025) Formulation and evaluation of emulgel containing Sucralfate and Dimethicone; A novel transdermal pharmaceutical dosage form. Journal of Research in Pharmacy 26 5 1125–1137.
IEEE F. Ghanbarveisi, Z. Pourmanouchehri, S. Khaledian, ve L. Behbood, “Formulation and evaluation of emulgel containing Sucralfate and Dimethicone; A novel transdermal pharmaceutical dosage form”, J. Res. Pharm., c. 26, sy. 5, ss. 1125–1137, 2025.
ISNAD Ghanbarveisi, Farnia vd. “Formulation and Evaluation of Emulgel Containing Sucralfate and Dimethicone; A Novel Transdermal Pharmaceutical Dosage Form”. Journal of Research in Pharmacy 26/5 (Haziran 2025), 1125-1137.
JAMA Ghanbarveisi F, Pourmanouchehri Z, Khaledian S, Behbood L. Formulation and evaluation of emulgel containing Sucralfate and Dimethicone; A novel transdermal pharmaceutical dosage form. J. Res. Pharm. 2025;26:1125–1137.
MLA Ghanbarveisi, Farnia vd. “Formulation and Evaluation of Emulgel Containing Sucralfate and Dimethicone; A Novel Transdermal Pharmaceutical Dosage Form”. Journal of Research in Pharmacy, c. 26, sy. 5, 2025, ss. 1125-37.
Vancouver Ghanbarveisi F, Pourmanouchehri Z, Khaledian S, Behbood L. Formulation and evaluation of emulgel containing Sucralfate and Dimethicone; A novel transdermal pharmaceutical dosage form. J. Res. Pharm. 2025;26(5):1125-37.