FORMULATION DEVELOPMENT AND OPTIMIZATION OF TABLET CONTAINING COMBINATION OF SALAM (SYZYGIUM POLYANTHUM) AND SAMBILOTO (ANDROGRAPHIS PANICULATA) ETHANOLIC EXTRACTS
Objective: The present study was aimed at finding the appropriate type of a binder and a disintegrant which can be used formulate tablets containing a combination of two ethanol extracts of Syzygium polyanthum leaves and Andrographis paniculata herbs, as well as to find their optimum concentrations which would produce the tablets with desired hardness and disintegration time.
Methods: Tablet manufacturing was done in two methods with the use of PVP K30 as a binder using the wet granulation method, and gelatin as a binder using the direct compression method. The design optimization used was the 22 full factorial designs with two factors and two levels, with the factors used being the binder concentration and the disintegrant.
Results: Tablets produced using gelatin as a binder had a hardness level similar to those using PVP K30 as a binder. However, their disintegration time was strongly affected by the choice of the binder. The result suggested that different binder (PVP K30 and gelatin) affected different disintegration time despite producing tablet hardness values that were almost identical.
Conclusion: The herbal tablet development of combined ethanolic extracts of Syzygium polyanthum and Andrographis paniculata herbs could be made using gelatin as a binder and crospovidone as a disintegrating agent using the direct compression method. The optimal formula was be obtained using gelatin 3.61% and crospovidone 3.45%, which had theoretical results in the hardness of 6.50 kp, the friability of 0.35%, and the disintegration time of 12.76 min.
Keywords: Syzygium polyanthum, Andrographis paniculata, Gelatin, Crospovidone, Optimization
The Ministry of Health. The Indonesian Herbal Pharmacopoeia. 1st Edition. Jakarta: Ministry of Health of the Republic of Indonesia; 2008.
Hadisoewignyo L, Ervina M, Soegianto L. Antioxidant activity, Antiinflamasi, and Ulcerogenic test of the combination Syzygium polyanthum Leaves-Andrographis paniculata leaves and its efficacy as an antidiabetes. Research Reports Higher Education. Surabaya: Widya Mandala Catholic University; 2013.
Nagadivya P, Ramakrishna R, Sridhar G, Bhanushashank R. Effect of binding agents on tablet hardness and release rate profile of diclofenac sodium tablets. Int J Res Pharm Sci 2012;3:12-6.
Nguyen MV. Simple Tablet Compression Using Gelatin. US Patent No. 6,569,954 B2; 2003.
Pahwa R, Gupta N. Superdisintegrants in the development of orally disintegrating tablets: a review. Int J Pharm Sci Res 2008;2:2767-80.
Kumar GP, Nirmala R. Fundamental aspects of super disintegrants: a concise review. J Global Pharma Technol 2012;4:1-12.
Swarbrick J. Encyclopedia of pharmaceutical technology. 3rd Edition. USA: Informa Healthcare; 2007.
Hadisoewignyo L, Fudholi A. Solid Dosage Formulation. Yogyakarta: Pustaka Pelajar; 2013.
Humadi SS, Istudor V. Quantitative analysis of bio-active compound in Sadarifa hibiscus L. extract. note I: quantitative analysis of flavonoids. Farmacia 2008;56:699-707.
The Ministry of Health. Indonesian Pharmacopoeia. 3rd Edition. Jakarta: Ministry of Health of the Republic of Indonesia; 1979.
Prakash ELS, Kadar ASH, Nagireddy D, Reeta VRK, Manavalan R. Evaluation of In-vitro antioxidant activity of leaf extract of Andrographis paniculata. Res J Pharm Biol Chem Sci 2011;2:891-5.
Ameh SJ, Obodozie OO, Inyang US, Abubakar MS, Garba M. Quality control tests on Andrographis paniculata needs (Family: Acanthaceae)-an Indian "Wonder" plant is grown in nigeria. Trop J Pharm Res 2010;9:387-94.
Wicaksono FM, Sari DSP, Sekti BH, Sari Y, Natalia E, Lyrawati D, et al. Piperantha: combination therapy innovation esktak syzygium polyanthus leaf (Eugenia polyantha) and red betel (Piper crocatum) activity against increased FAS/FAS-L on regression cervical cancer growth in vitro. Malang: Brawijaya University; 2013.
Aiyelaagbe OO, Osamudiamen PM. Phytochemical screening for active compounds in Mangifera indica. Plant Sci Res 2009;2:11-3.
Hendriati L, Ferawati, Surjadhana A, Jonosewojo A, Widjajakusuma EC. Optimization of PVP K30 as binder and krospovidon as disintegrant of sambiloto-salam tablets. Perhiba 2011;7:382-6.