FORMULASI DAN UJI STABILITAS FISIKA DAN pH KRIM PENCERAH KULIT HIDROKUINON 4% SERTA KOMBINASI HIDROKUINON 4% DAN TRETINOIN 0,1% DENGAN POLYACRILAMIDE & C13-14 ISOPARAFFIN & LAURETH-7 DAN CETEARYL ALCOHOL & CETEARYL GLUCOSIDE SEBAGAI EMULGATOR

  • Ade Widya Lestari Fakultas Farmasi / Universtias Surabaya
Abstract Views: 1570 times
PDF - FULL TEXT Downloads: 4661 times
Keywords: stabilitas fisika, krim, kombinasi Hidrokuinon, Tretinoin

Abstract

Abstrak. Telah dilakukan penelitian stabilitas fisika sediaan krim yang mengandung basis krim tanpa bahan aktif (Formula I), 4% Hidrokuinon (Formula II) serta kombinasi 4% Hidrokuinon dan 0,1% Tretinoin (Formula III) dengan bahan pengemulsi kombinasi polyacrilamide & c13-14 isoparaffin & laureth-7 dan cetearyl alcohol & cetearyl glucoside yang disimpan dalam alat climatic chamber pada suhu 40o C ± 2o C / RH 75% ± 5% selama 30 hari. Pengamatan stabilitas fisika dilakukan pada hari ke-0, 8 dan 30. Data hasil pengamatan stabilitas fisika sediaan krim selama waktu penyimpanan yang meliputi organoleptis, viskositas, sifat alir, tipe emulsi, berat jenis, daya sebar, pH dan ukuran droplet dianalisis dengan one-way ANOVA (α=0,05). Hasil penelitian menunjukkan bahwa sediaan krim Formula I tidak stabil dalam hal viskositas, berat jenis, organoleptis dan pH, Formula II tidak stabil dalam hal viskositas, berat jenis, organoleptis, daya sebar, sedangkan Formula III menunjukkan ketidakstabilan dalam hal berat jenis, viskositas, organoleptis, daya sebar dan pH. Sedian Formula I, II dan III menunjukkan perbedaan karakteristik fisika yang bermakna dalam viskositas, berat jenis, daya sebar dan pH.

Abstract. A research on physical stability of cream stock which contains cream base without active material (Formula I), 4% Hidrokuinon (Formula II) and combinations 4% Hidrokuinon and 0,1% Tretinoin (Formula III) with the emulsifying agents by using polyacrilamide & c13-14 isoparaffin & laureth-7 dan cetearyl alcohol & cetearyl glucoside combinations which have been stored in climatic chamber at 40o C ± 2o C / RH 75% ± 5% for 30 days, has been performed. Physical stability observation was performed on day 0, 8 and 30. Data of observing physical stability of cream during storage phase which included organoleptic, viscosity, flow properties, emulsion type, specific gravity, pH, spredibilitas and droplet size was analyzed with one-way ANOVA (α=0,05). Study result showed that Formula I cream unstable in viscosity, specific gravity, pH and organoleptics, Formula II was unstable in viscosity, specific gravity, organoleptics and spredibilitas while Formula III showed instability in specific gravity, viscosity, organoleptics, spredibilitas and pH. Formula I, II and III stocks showed significant physical characteristics differences in viscosity, specific gravity, spredibilitas and pH.

Kata kunci: stabilitas fisika, krim, kombinasi Hidrokuinon dan Tretinoin.

Downloads

Download data is not yet available.

References

Agoes, Guswin. 2012. Pengembangan Sediaan Farmasi. Bandung: ITB Press. Hal 195-197.

Amiruddin Md, Editor. 2003. Ilmu Penyakit Kulit. Jogjakarta: LKIS. Hal 147-67.

Ansel, Howard C. 1989. Pengantar Bentuk Sediaan Farmasi. Edisi Ke Empat Cetakan Pertama. Jakarta: Penerbit Universitas Indonesia Press. Hal 224

Anief, Moh. 1994. Ilmu Farmasi. Yogyakarta: Gajah Mada University Press. Hal 61-62

Asean Guideline. 2005. Asean Guideline On Stability Study Of Drug Product. Asean Consultative Committee For Standard And Quality, Philiphines.

Badan Pom Republik Indonesia. 2009. Public Warning Tentang Kosmetik Mengandung Bahan Berbahaya/Bahan Dilarang. Hal 1-2.

BPOM. 2010. Petunjuk Operasional Pedoman Cara Pembuatan Kosmetik Yang Baik, Direktorat Standardisasi Obat Tradisional, Kosmetik Dan Produk Komplemen Badan Pengawas Obat Dan Makanan Republik Indonesia.

Cestari T, Hexsel D, Viegas M, Et Al: Validation Of A Melasma Quality Of Life Questionnaire For Brazilian Portuguese Language: The Melasqol-Bp Study And Improvement Of Qol Of Melasma Patients After Triple Combination Therapy. Br J

Dermatol 156:13-20, 2006 , (Online), (Http://Www.Obgynnews.Com Diakses 10-09-2015)

Clariant. 2005. PhenonipTM Preservative For Cosmetic Industry. Clariant. Switzerland.

Dirjen POM. 1995. Farmaskope Indonesia. Edisi IV. Jakarta: Departemen Kesehatan Republik Indonesia. Hal 4, 6, 1083.

Djajadisastra, Joshita. 2004. Cosmetic Stability Disampaikan Pada “Seminar Setengah Hari Hiki” 18 November 2004.

Djuanda Adhi. 2007. Ilmu Penyakit Kulit Dan Kelamin. Edisi Kelima. Balai Penerbit FKUI. Jakarta

Drug Stability Guidelines. 2008 U.S. Department Of Health And Human Services Food And Drug Administration Center Of Veterinary Medicine (CVM). (240) 276-8268

Ebanks, Jody P., R. Randall Wickeet Dan Raymond E. Boissy. 2009. Review Mechanism Regulating Skin Pigmentation: The Rise And Fall Of Complexion Coloration. International Journal Of Molecular Science. 10: 4066-4087 September 2009.

Gennaro, A.R., Marderasian, A.H.D., Hanson, G.R., Medwick, T. 2006 Remington: The Science And Practice Of Pharmacy, 21st Ed., Lippincott Williams & Wilkins, Usa, Hal 828.

Gladstone HB, Nguyen Sl, Williams R, Et Al: Efficacy Of Hydroquinone Cream (Usp 4%) Used Alone Or In Combination With Salicylic Acid Peels In Improving Photodamage On The Neck And Upper Chest. Dermatol Surg 26:333-337. 2000. (Online), (Http://Www.Obgynnews.Com Diakses 10-09-2015)

Grimes PE. Managment Of Hyperpigmentation In Darker Racial Ethnic Groups. Semin Cutan Med Surg. 2009;28: 77–85, (Online), (Http://Www.Jcadonline.Com Diakses 11-09-2015).

Guevara Il, Pandya Ag: Safety And Efficacy Of 4% Hydroquinone Combined With 10% Glycolic Acid Antioxidants, And Sunscreen In The Treatment Of Melasma. Int J
Dermato L42:966-972, 2003, (Online), (Http://Www.Obgynnews.Com Diakses 10-09-2015)

Guidelines On Stability Testing Of Cosmetics Products. 2004. Cosmetic, Toiletry And Fragnance Association (Ctfa) Dan The Ueropean Cosmetic Toiletry And Perfumery Association (COLIPA). (Online). (Diakses 02 Agustus 2015)

Kunachak S, Leelaudomlipi P, Wongwaisayawan S. Dermabrasion: A Curative Treatment For Melasma. Aesthetic Plast Surg 2001;25(2):114-7

Lynde Cb Et Al. Novel Agents For Intractable Itch. Skin Therapy Lett. 2008. 13 : 6

Manurung. Juli 2006. Pemastian Mutu Obat: Kompendium Pedoman Dan BahanBahan Terkait, Vol 1, Jakarta: Penerbit Buku Kedokteran Egc.

National Health Surveillance Agency. 2005. Cosmetic Products Stability Guide, Brasillia, Anvisa Publishing House

Rowe, R.C., Sheskey P.J., Owen, S.C. 2009. Handbook Of Pharmaceutic Exipients 5th Edition. London: Pharmaceutical Press And American Pharmacist Association.

Seppic, 2011. MontanovTM 68: An Emulsifier In Harmony With Nature, Seppic, France (Online), (Http://Www.Seppic.Com Diakses Pada Tanggal 20-08-2015)

Sinko, Patrick J. 2012. Farmasi Fisika Dan Ilmu Farmasetika Ed 5. Jakarta: Penerbit Buku Kedokteran EGC

Soepardiman L. Kelainan Pigmen. Dalam: Djuanda A, Hamzah M, Aisah S, Editor. Ilmu Penyakit Kulit Dan Kelamin Edisi Ke 4. Jakarta: Balai Penerbit Fkui; 2005. H.
289-92.

Stability Testing Of New Drug Substance And Products. 2003. International Conferences On Humanisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. Q1a(R2)

Stability Testing Of Active Pharmaceutical Ingridients And Finished Pharmaceutical Products. 2009. World Health Organization Technical Report Series. No 953.

Syamsuni, H. A. 2006. Ilmu Resep. Penerbit Buku Kedokteran Egc, Jakarta. Hal 166-171.

Taylor Sc, Torok H, Jones T, Et Al: Efficacy And Safety Of A New Triplecombination Agent For The Treatment Of Facial Melasma. Cutis 72:67-72, 2003. (Online),(Http://Www.Skinmedjournal.Com Diakses Pada 17 Juni 2015)

Voigt, R., 1994, Buku Pelajaran Tekhnologi Farmasi, Yogyakarta: Gajah Mada University Press. Hal 370, 398-434.

Wibowo DS. 2005. Anatomi Tubuh Manusia. Grasindo. Jakarta. Hal 15-25.

Zuidhoff HW. 2000. The Whitening Properties Of Lactic Acid And Lactates Dalam Personal Care Ingridients Asia: Conferences Proceeding. Maret 2000. England. Hal 85-87
Published
2017-09-01