Design-Expert Software sebagai Alat Optimasi Formulasi Sediaan Farmasi
Abstrak
Salah satu tahap dalam pengembangan obat adalah formulasi untuk mendapatkan formula yang optimum. Dengan formula yang optimum maka kualitas sediaan baik dan memenuhi parameter-parameter baku. Tahap ini dilakukan melalui eksperimen laboratorium dan analisis hasil percobaan yang umunya cukup memakan waktu. Untuk mengatasi hal tersebut dapat dilakukan pendekatan menggunakan piranti lunak dengan teknologi komputer yaitu Design-Expert software dalam membantu mendesain variasi formula pada preformulasi dan analisis hasil percobaan post formulasi. Tujuan dari review ini adalah muntuk mengetahui pemanfaatan Design-Expert software dalam penelitian formulasi dan optimasi. Metode penulisan kajian pustaka dilakukan dengan pencarian pada Google scholar dan ScinceDirect dengan kata kunci “Formulation” dan “Design-Expert” menghasilkan penemuan 63 artikel dan skrining dengan menerapkan kriteria inklusi yaitu artikel penelitian optimasi formulasi dengan rentang tahun terbit antara 2011 – April 2020 dan eksklusi berupa artikel berbentuk review artikel. Berdasarkan hasil kajian pustaka dapat disimpulkan bahwa Design-Expert software banyak digunakan dan bermanfaat dalam mengurangi waktu, dan biaya pengembangan formulasi.
Kata Kunci
Teks Lengkap:
PDFReferensi
Singh BS, Kapil R, Ahuja N. Systematic optimisation of drug delivery systems: an insight. Pharm Rev. 2008;7:146–186.
Ramadhani RA, Riyadi DHS, Triwibowo B, Kusumaningtyas RD. Review Pemanfaatan Design Expert untuk Optimasi Komposisi Campuran Minyak Nabati sebagai Bahan Baku Sintesis Biodiesel. J Tek Kim Dan Lingkung. 2017 Oct 11;1(1):11.
Carriere J, Vaughn N, Kraber J, Sobczyk P, Bronikowski P, Mazur JM, et al. Design-Expert. 1300 Godward Street Northeast, Suite 6400 Minneapolis, MN 55413: Stat-ease, Inc.; 2019.
Bolton S, Bon C. Pharmaceutical statistics: practical and clinical applications. 4th ed., rev.expanded. New York: M. Dekker; 2004. 755 p. (Drugs and the pharmaceutical sciences).
Montgomery DC. Design and Analysis of Experiments. 9th Edition. 2017.
Purwanti EP, Pilarian F. S - 11 OPTIMASI PARAMETER PROSES PEMOTONGAN STAINLESS STEEL SUS 304 UNTUK KEKASARAN PERMUKAAN DENGAN METODE RESPONSE SURFACE. 2013;16.
Perincek O, Colak M. Use of Experimental Box-Behnken Design for the Estimation of Interactions Between Harmonic Currents Produced by Single Phase Loads. Int J Eng Res Appl. 2013;3(2):8.
Damayanti D, Sari IP, Sulaiman TNS, Bestari AN, Setiawan IM. The Formulation of Pacing (Costus speciosus) Extract Tablet by Using Avicel®Ph 200 As Filler-Binder and Amylum As Disintegration Agent. Indones J Pharm. 2018 Jan 2;29(1):29.
Murrukmihadi. In Optimasi Formula Sediaan Sirup Mukolitik Vitro Fraksi Terstandar Bunga Kembang Sepatu (Hibiscus rosa-sinensis L.). Dr Diss. 2012;
Sainah S. Optimasi Formula Suspensi Siprofloksasin dengan Kombinasi Pulvis Gummi Arabici (Pga) dan Carbopol 934 Menggunakan Metode Desain Faktorial [PhD Thesis]. Tanjungpura University; 2013.
Qisti BWK, Nurahmanto D, Rosyidi VA. Optimasi Propilen Glikol dan Etanol sebagai Peningkat Penetrasi Ibuprofen dalam Sediaan Gel dengan Metode Simplex Lattice Design. 2018;6(1):7.
Elcistia R, Zulkarnain AK. Optimasi Formula Sediaan Krim o/w Kombinasi Oksibenzon dan Titanium Dioksida Serta Uji Aktivitas Tabir Suryanya Secara In Vivo. Maj Farm. 2019 Jan 14;14(2):63.
Choudhury P, Deb P, Dash S. FORMULATION AND STATISTICAL OPTIMIZATION OF BILAYER SUBLINGUAL TABLETS OF LEVOCETIRIZINE HYDROCHLORIDE AND AMBROXOL HYDROCHLORIDE. Asian J Pharm Clin Res. 2016 Sep 1;9(5):228.
Usman S, Ejaz RR, Safdar KA. Formulation development and optimization of orally disintegrating tablets of montelukast sodium by Design- Expert. Trop J Pharm Res. 2018 Oct 3;17(9):1701.
Khadabadi DSS, Chishti NH, Khan FM, Tadvee AA. FORMULATION AND EVALUATION OF PRESS COATED TABLET OF KETOPROFEN – A CHRONOTHERAPEUTIC APPROACH. 2013;5:8.
Bushra R, Shoaib MH, Ali H, Zafar F, Naeem MI, Aslam N, et al. Formulation Design and Optimization of Aceclofenac Tablets (100 mg) Using Central Composite Design with Response Surface Methodology. 2014;11.
Na Y-G, Jeon S-H, Byeon J-J, Kim M-K, Lee H-K, Cho C-W. Application of statistical design on the early development of sustained-release tablet containing ivy leaf extract. J Drug Deliv Sci Technol. 2019 Dec;54:101319.
Esim O, Savaser A, Ozkan CK, Bayrak Z, Tas C, Ozkan Y. Effect of polymer type on characteristics of buccal tablets using factorial design. Saudi Pharm J. 2018 Jan;26(1):53–63.
Naveen NR, Gopinath C, Rao DS. Design expert supported mathematical optimization of repaglinide gastroretentive floating tablets: In vitro and in vivo evaluation. Future J Pharm Sci. 2017 Dec;3(2):140–7.
Reddy Y, Chetty C, Kumar K, Dachinamoorthi D. Formulation and Optimization of Extended Release Matrix Tablets of Losartan Potassium Using Response Surface Methodology (RSM). J Pharm Res Int. 2017 Jan 10;19(5):1–12.
Sarkhejiya NA, Khachar KK, Patel VP. Formulation Development and Evaluation of Sublingual Tablet of Risperidone. 2013;7.
Widiastuti L. Formulasi Granul Kombinasi Ekstrak Terpurifikasi Herba Pegagan (Centella asiatica (L.) Urban) dan Herba Sambiloto (Andrographis paniculata (Burm. f.) Nees) [PhD Thesis]. Universitas Gadjah Mada; 2013.
Putra IMWA, Mustika IG. Potensi Zat Aktif Antikanker Solasodin Terenkapusulasi Pada Zeolit Klinoptilolit Sebagai Sistem Pengantar Obat (Drug Delivery System). Cakra Kim Indones E-J Appl Chem. 2016 Oktober;4(2):1–10.
Mehdizadeh A, Ghahremani MH, Rouini MR, Toliyat T. Effects of pressure sensitive adhesives and chemical permeation enhancers on the permeability of fentanyl through excised rat skin. Acta Pharm. 2006;11
Mehdizadeh A, Ghahremani MH, Rouini MR, Toliyat T. Effects of pressure sensitive adhesives and chemical permeation enhancers on the permeability of fentanyl through excised rat skin. Acta Pharm. 2006;11.
Hosny KM, Rizg WY, Khallaf RA. Preparation and Optimization of In Situ Gel Loaded with Rosuvastatin-Ellagic Acid Nanotransfersomes to Enhance the Anti-Proliferative Activity. Pharmaceutics. 2020 Mar 13;12(3):263.
Kumar S, Nagori BP, Issarani R, Ahuja M. Ocular Insert: Dosage Form for Sustain Opthalmic Drug Delivery. 2012;1:13.
Sun M, Han J, Guo X, Li Z, Yang J, Zhang Y, et al. Design, preparation and in vitro evaluation of paclitaxel-loaded self-nanoemulsifying drug delivery system. Asian J Pharm Sci. 2011;8.
Taghizadeh SM, Moghimi-Ardakani A, Mohamadnia F. A statistical experimental design approach to evaluate the influence of various penetration enhancers on transdermal drug delivery of buprenorphine. J Adv Res. 2015 Mar;6(2):155–62.
Ahmed OAA, Badr-Eldin SM. Development of an optimized avanafil-loaded invasomal transdermal film: Ex vivo skin permeation and in vivo evaluation. Int J Pharm. 2019 Oct;570:118657.
Malakar J, Sen SO, Nayak AK, Sen KK. Formulation, optimization and evaluation of transferosomal gel for transdermal insulin delivery. Saudi Pharm J. 2012 Oct;20(4):355–63.
Chauhan MK, Sharma PK. Optimization and characterization of rivastigmine nanolipid carrier loaded transdermal patches for the treatment of dementia. Chem Phys Lipids. 2019 Nov;224:104794.
Ma H, Guo D, Fan Y, Wang J, Cheng J, Zhang X. Paeonol-Loaded Ethosomes as Transdermal Delivery Carriers: Design, Preparation and Evaluation. Molecules. 2018 Jul 17;23(7):1756.
Michaelis M, Leopold CS. Mixture design approach for early stage formulation development of a transdermal delivery system. Drug Dev Ind Pharm. 2015 Sep 2;41(9):1532–40.
Akhlaq M, Arshad MS, Mudassir AM, Hussain A, Kucuk I, Haj-Ahmad R, et al. Formulation and evaluation of anti-rheumatic dexibuprofen transdermal patches: a quality-by-design approach. J Drug Target. 2016 Aug 8;24(7):603–12.
Duangjit S, Mehr LM, Kumpugdee-Vollrath M, Ngawhirunpat T. Role of Simplex Lattice Statistical Design in the Formulation and Optimization of Microemulsions for Transdermal Delivery. Biol Pharm Bull. 2014;37(12):1948–57.
Nanda DS, Saroha K, Sharma B. Formulation, Evaluation And Optimization Of Transdermal Gel Of Ketorolac Tromethamine Using Face Centered Central Composite Design. 2014;6(4):7.
Kamran Mohd, Ahad A, Aqil Mohd, Imam SS, Sultana Y, Ali A. Design, formulation and optimization of novel soft nano-carriers for transdermal olmesartan medoxomil delivery: In vitro characterization and in vivo pharmacokinetic assessment. Int J Pharm. 2016 May;505(1–2):147–58.
Elmotasem H, Awad GEA. A stepwise optimization strategy to formulate in situ gelling formulations comprising fluconazole-hydroxypropyl-beta-cyclodextrin complex loaded niosomal vesicles and Eudragit nanoparticles for enhanced antifungal activity and prolonged ocular delivery. Asian J Pharm Sci. 2019 Dec;S1818087619307962.
Patel S, Koradia H, Parikh R. Design and development of intranasal in situ gelling system of Midazolam hydrochloride using 32 full factorial design. J Drug Deliv Sci Technol. 2015 Dec;30:154–62.
Alharbi WS, Hosny KM. Development and optimization of ocular in situ gels loaded with ciprofloxacin cubic liquid crystalline nanoparticles. J Drug Deliv Sci Technol. 2020 Jun;57:101710.
Wadetwar RN, Agrawal AR, Kanojiya PS. In situ gel containing Bimatoprost solid lipid nanoparticles for ocular delivery: In-vitro and ex-vivo evaluation. J Drug Deliv Sci Technol. 2020 Apr;56:101575.
Shah V, Sharma M, Pandya R, Parikh RK, Bharatiya B, Shukla A, et al. Quality by Design approach for an in situ gelling microemulsion of Lorazepam via intranasal route. Mater Sci Eng C. 2017 Jun;75:1231–41.
Das T, Venkatesh MP, Pramod Kumar TM, Koland M. SLN based alendronate in situ gel as an implantable drug delivery system – A full factorial design approach. J Drug Deliv Sci Technol. 2020 Feb;55:101415.
Rao M, Agrawal DK, Shirsath C. Thermoreversible mucoadhesive in situ nasal gel for treatment of Parkinson’s disease. Drug Dev Ind Pharm. 2017 Jan 2;43(1):142–50.
Galgatte UC, Kumbhar AB, Chaudhari PD. Development of in situ gel for nasal delivery: design, optimization, in vitro and in vivo evaluation. Drug Deliv. 2014 Feb;21(1):62–73.
Shastri D, Prajapati S, Patel L. Thermoreversible mucoadhesive ophthalmic in situ hydrogel: Design and optimization using a combination of polymers. Acta Pharm [Internet]. 2010 Jan 1 [cited 2020 Jun 9];60(3). Available from: https://content.sciendo.com/doi/10.2478/v10007-010-0029-4.
Shivakumar HN, Desai BG, Subhash PG, Ashok P, Hulakoti B. Design of ocular inserts of brimonidine tartrate by response surface methodology. J Drug Deliv Sci Technol. 2007;17(6):421–30.
Bhattacharjee A, Das PJ, Dey S, Nayak AK, Roy PKr, Chakrabarti S, et al. Development and optimization of besifloxacin hydrochloride loaded liposomal gel prepared by thin film hydration method using 32 full factorial design. Colloids Surf Physicochem Eng Asp. 2020 Jan;585:124071.
Patil SS, Bade A, Tagalpallewar A. Design, optimization and pharmacodynamic comparison of dorzolamide hydrochloride soluble ocular drug insert prepared by using 3 2 factorial design. J Drug Deliv Sci Technol. 2018 Aug;46:138–47.
Ranch KM, Maulvi FA, Naik MJ, Koli AR, Parikh RK, Shah DO. Optimization of a novel in situ gel for sustained ocular drug delivery using Box-Behnken design: In vitro, ex vivo, in vivo and human studies. Int J Pharm. 2019 Jan;554:264–75.
Abdelbary AA, Abd-Elsalam WH, Al-mahallawi AM. Fabrication of novel ultradeformable bilosomes for enhanced ocular delivery of terconazole: In vitro characterization, ex vivo permeation and in vivo safety assessment. Int J Pharm. 2016 Nov;513(1–2):688–96.
Chopra AK, Marwaha RK, Deepak K. Box-Behnken Designed Fluconazole Loaded Chitosan Nanoparticles for Ocular Delivery. J Pharm Drug Deliv Res [Internet]. 2014 [cited 2020 Jun 9];03(01). Available from: http://scitechnol.com/boxbehnken-designed-fluconazole-loaded-chitosan-nanoparticles-for-ocular-delivery-9tum.php?article_id=2488
Avinash K, Ajay S. FORMULATION AND EVALUATION OF THERMOREVERSIBLE IN SITU OCULAR GEL OF CLONIDINE HYDROCHLORIDE FOR GLAUCOMA. 2015;6:13.
Pratiwi L, Fudholi A, Martien R, Pramono S. Self-nanoemulsifying Drug Delivery System (Snedds) for Topical Delivery of Mangosteen Peels (Garcinia Mangostana L.,): Formulation Design and In vitro Studies. J Young Pharm. 2017 Jul 1;9(3):341–6.
Astuti IY, Marchaban M, Martien R, Nugroho AE. Design and Optimization of Self Nano-Emulsifying Drug Delivery System Containing a New Anti-inflamatory Agent Pentagamavunon-0. Indones J Chem. 2017 Nov 30;17(3):365–75.
Garg V, Kaur P, Singh SK, Kumar B, Bawa P, Gulati M, et al. Solid self-nanoemulsifying drug delivery systems for oral delivery of polypeptide-k: Formulation, optimization, in-vitro and in-vivo antidiabetic evaluation. Eur J Pharm Sci. 2017 Nov;109:297–315.
Arya A, Ahmad H, Tulsankar S, Agrawal S, Mittapelly N, Boda R, et al. Bioflavonoid hesperetin overcome bicalutamide induced toxicity by co-delivery in novel SNEDDS formulations: Optimization, in vivo evaluation and uptake mechanism. Mater Sci Eng C. 2017 Feb;71:954–64.
Villar AMS, Naveros BC, Campmany ACC, Trenchs MA, Rocabert CB, Bellowa LH. Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil. Int J Pharm. 2012 Jul;431(1–2):161–75.
Singh G, Pai RS. Optimized self-nanoemulsifying drug delivery system of atazanavir with enhanced oral bioavailability: in vitro/in vivo characterization. Expert Opin Drug Deliv. 2014 Jul;11(7):1023–32.
Marasini N, Yan YD, Poudel BK, Choi H, Yong CS, Kim JO. Development and Optimization of Self‐Nanoemulsifying Drug Delivery System with Enhanced Bioavailability by Box–Behnken Design and Desirability Function. J Pharm Sci. 2012 Dec;101(12):4584–96.
Parmar K, Patel J, Sheth N. Self nano-emulsifying drug delivery system for Embelin: Design, characterization and in-vitro studies. Asian J Pharm Sci. 2015 Oct;10(5):396–404.
Dash RN, Mohammed H, Humaira T, Ramesh D. Design, optimization and evaluation of glipizide solid self-nanoemulsifying drug delivery for enhanced solubility and dissolution. Saudi Pharm J. 2015 Oct;23(5):528–40.
Fithri NA, Mardiyanto M, Novita RP, Andrean V. Furosemide self nano emulsifying drug delivery system (SNEDDS) formulation comprising of capryol-90, polysorbate-80, and peg-400 with simplex-lattice-design. Sci Technol Indones. 2017 Oct 3;2(4):85–8.
Refbacks
- Saat ini tidak ada refbacks.