Uji disolusi terbanding tablet parasetamol
DOI:
https://doi.org/10.32670/ht.v2i3.1451Keywords:
differential dissolution test, acetaminophen tabletsAbstract
The dissolution test was conducted to determine the effect of the formulation and
fabrication processes on the dissolution profile in estimating the bioavailability and
bioequivalence between the test and comparison products. The comparable dissolution
test used 3 different dissolution mediums were hydrochloric acid pH 1,2 or simulated
gastric fluid without enzymes, citrate buffer medium pH 4.5 and phosphate buffer
medium pH 6.8 or simulated intestinal fluid without enzymes. The first study used 12
tablets of Panadol which were randomly selected. Then, the results were compared
using two independent model methods were the difference factor (f1) and the similarity
factor (f2). Based on this, the similarity factor in the three media is in the acceptable
range of 50-
100. Another study conducted testing using acetaminophen samples purchased from
Rochem, Turkey. The results obtained were in accordance with USP guidelines namely
conventional acetaminophen tablets should be released at at least 80% of the labeled
amount in 30 minutes. In another study also compared the dissolution profile of 4 coated
and noncoated tablets. All formulations within the first 45 minutes had a drug release
of more than 85%.
References
Abdou, H. M. 1989. Dissolution, Bioavailability and Bioequivalence. EastonPennsylvania: Mack Publishing Company.
Banakar, U.V. 1992. Pharmaceutical Dissolution Testing. New York : Marcel BPOM RI.
Pedoman Uji Bioekivalensi. Jakarta: Badan Pengawasan Obat
dan Makanan Republik Indonesia.
BPOM RI. 2005. Peraturan Kepala Badan Pengawasan Obat dan Makanan Indonesia
No. HK 00.05.3.1818 Tentang Pedoman Uji Bioekivalensi. Jakarta: Badan
Pengawasan Obat dan Makanan Republik Indonesia.
British Pharmacopoeia Commission. 2012. British Pharmacopeia. London: Stationary
office.
Convention, U.S.P. 2009. USP 32 NF 32 : United States Pharmacopeia and National
Formulary. Vol 2. Rockville: United States Pharmacopeial Convention Dekker Inc.
Depkes RI. 1989. Keputusan Direktur Jenderal Pengawasan Obat dan Makanan Nomor:
/A/SK/XII/89. Jakarta: Departemen Kesehatan Republik Indonesia.
FDA. 2000. Guidance for Industry: Waiver of In Vivo Bioavailibility and Bioequivalence
Studies for Immediate-Release Solid Oral Dosage Forms Based on a
Biopharmaceuticas Claasification Systems. Rockville: U.S. Department of Health.
HHS/FDA. 1997. Guidance For Industry: Dissolution Testing of Immediate Release Solid
Oral Dosage Forms. Rockville: U.S. Department of Health and Human Service
Food and Drug Administration.
Kemenkes RI. 2014. Farmakope Indonesia. Edisi V. Jilid II. Jakarta: Kementrian
Kesehatan Republik Indonesia.
Martindale, W. 2009. Martindale: The Extra Pharmacopoeia. 27th Edition.
London: The Pharmaceutical Press.
Ozyilmaz1, D. E., T. Comoglu., dan R. Nourmohammadi. 2020. Comparison of The
Pharmaceutical Properties of Paracetamol Tablets Belonging to Different
Companies in The Northern Cyprus Pharmaceutical Market. Jurnal of
Pharmaceutial Sciences. 3(2) : 73-79.
Rathnayake, A. D., M. Uthpali, T. Dhanusha, P. B. H. Kamal, G. Priyadarshani, dan L. J.
Ravindra. 2014. Determination of in vitro Equivalence of Paracetamol Tablets.
International Journal in Multidisciplinary Studies. 1(1): 1-7.
Shargel, L. 1999. Applied Biopharmaceutics 4th edisition. London: Princice-Hall
International.
Suhesti, T. S., dan Rachmani, E. P. N. 2018. Disolusi Terbanding Tablet Asetaminofen
Produk Generik Berlogo dan Produk Bermerek. Acta Pharmaciae Indonesia. 6(2):
-65.
Todorovic, N.B., Svetlana, S. G.K., Kristina, N. K., Jelena, N. J. B., Nebojsa, M. P., Boris,
Z. M., dan Mladena, N. L. P. 2018. Influence of Immediate Release Tablet
Formulation on Dissolution Profile of Paracetamol. Hospital Pharmacology. 5(3):
-714.
Yuliani, R. 2015. Profil Disolusi Tablet Parasetamol Generik Berlogo (OGB) Dan
Generik Bermerk Dagang Secara In Vitro Dengan Modifikasi Alat Disintegrator.
Karya Tulis Ilmiah. Jurusan Farmasi Kementerian Kesehatan RI Politeknik
Kesehatan Bandung.
