Objective: The aim of the present study was to obtain an optimized formula of meniran (Phyllanthus niruri L.) extract tablets that fulfilled the requirements as a good pharmaceutical preparation based on Indonesian Pharmacopoeia IV and USP XVII.Methods: P. niruri plant was collected and determined at the Laboratory of Plant Taxonomy, Universitas Padjadjaran. First performed phytochemical screening to determine the content of secondary metabolites. Then designed five kinds of tablet formulas of P. niruri extract using a direct compressed method with a variation of concentration of filler. Each formula contains a similar concentration of P. niruri extract as the active ingredient, avicel PH 102 and amprotab with varying concentrations as filler, talcum, and magnesium stearate as a lubricant and Aerosil®200 vv as an adsorbent. Tablet print mass and quality of the resulting tablets were then evaluated. Also, check whether the resulting tablets still contain P. niruri extract as the active substance or not.Results: The results of phytochemical screening of simplicia and viscous plant extract showed the presence of alkaloids, polyphenols, tannins, and flavonoids as secondary metabolites. The five formulas made contain avicel PH 102 and amprotab as binders and crushers and the expected results such as shape and durability as desired. The results of examination of shrinkage rate of mass drying of tablet prints from the above five formulas indicated an increase of value from formula A (5.4609 %) to formula E (5.8600%). This was because avicel PH 102 and amprotab had a considerable moisture content, so with the combination of both fillers could increase the water content from mass print tablets. Real density, compact density, and true density decreased from formula A to formula E. The amount of these densities were influenced by the shape and size of the particles. Flowability increased from formula A (23.7124°) to formula E (26.4210°) whereas compressibility increased from formula A (21.7222%) to formula E (29,4121%). Flowability and compressibility increase might be due to the uniformity of the particle size between the amprotabs and the other additives which could cause electrical charges to the print mass affecting the speed and flow of the print mass. All quality testing results including Weight (mg), Thickness (mm), Diameter (mm), Hardness (N), Friability (%) and Disintegration time (min.) had met the requirements. Thin Layer Chromatography showed that the resulting tablets still contain P. niruri extract as the active substance.Conclusion:. Overall results showed that the formulation fulfilled the requirements as a good pharmaceutical preparation based on Indonesian Pharmacopoeia IV and USP XVII.
Objective: The drug will provide a therapeutic effect when dissolved so that it is easily absorbed. The process of dissolving drugs is called dissolution. Additional substances contained in pharmaceutical preparations, one of which serves to accelerate the solubility of active substances. The aim of this study was to obtain a comparative composition of Ludipress® and lactose additives suitable for producing ambroxol HCl tablets that met the ambroxol acceleration ambroxol in the body. Methods: Ambroxol HCl tablets were made by direct pressing method. For research purposes, 4 formulas with variations of Ludipress® and Lactose were designed. The tablet was then evaluated, which includes uniformity in weight, diameter, thickness, hardness, friability, disintegration time, and dissolution. Data obtained in the analysis using the perfect random block design method (DBAS) with α = 0.05 where blocks and groups were used. Results: From the results of the Mass Printing Evaluation of Tablets, it was found that the four formulas that were designed met the resting angle, flow rate, real density, compressed density, and compressibility met existing requirements. The results of evaluation tablets, which included uniformity of weight, uniformity of size, hardness, friability, disintegration time, and dissolution test, were found that only F1 formula did not meet uniformity requirements. All four formulas meet the Indonesian pharmacopeia requirements for time of violence, fragility and disintegration. The dissolution test results showed that in the 45-minute test each percent dissolved concentration of the active substance for F1, F2, F3, and F4 was 58.77974, 66.91104, 80.09946, and 64.02293 suggesting only the F3 formula fulfilled the dissolution requirements according to European Pharmacopoeia which stated that the concentration of dissolved active tablets should not be less than 75% during the 45-minute test. Conclusion: The formula that met the solubility requirements consisted of an additional 69% Ludipress® and 10% lactose with a solubility value of 80.09%.
Objective: The objective of this research was to formulate Orally Disintegrating Tablets (ODT) preparations for secang (Caesalpinia sappan L.) wood extract as antioxidants that met the requirements as a pharmaceutical preparation. Methods: Three ODT formulas were made using the composition of the extract of secang wood, HPC-H, kollidon® CL, Avicel® PH 101, mannitol, acesulfame, magnesium stearate, citric acid, and menthol. The bitter taste of the extract of wood secang was covered with the Hydroxy Propyl Cellulose High Substitution (HPC-H) masking agent. Variations in HPC-H concentration were 4%, 4.5%, and 5%. The evaluation of tablet print mass tested included water content, flow velocity, and resting angle, real density, incompressible density, and compressibility. Evaluation of tablets tested included weight uniformity, uniformity of size, hardness, friability, and disintegration time. The tablet antioxidant activity testing was carried out by the Diphenylpicylhydrazyl (DPPH) method. Results: The results showed that all ODT formulas of secang wood extract were fulfilling the requirements as a tablet preparation according to Indonesian Pharmacopoeia IV. IC50 values obtained from antioxidant testing on the three ODT formulas for a secang wood extract for formula I was 3.614 ppm, formula II was 3.464 ppm, formula III was 3.173 ppm, and the wood extract was 3.757 ppm. Conclusion: The results obtained in this research work clearly indicated ODT formulas of secang wood extract fulfilled Indonesian Pharmacopea IV requirement and belong to the category of very strong antioxidants because they have an IC50 value of less than 50 ppm.
Indonesia adalah negara yang kaya akan tanaman obat. Salah satu tanaman yang dapat digunakan sebagai bahan obat adalah pala (Myristica fragrans Houtt.). Namun, kandungan miristisin dan safrol pada biji pala memberikan efek yang tidak diharapkan bagi tubuh sehingga harus dipisahkan terlebih dahulu sebelum digunakan. Pemisahan miristisin dan safrol dapat dilakukan dengan metode kromatografi kolom sehingga diperoleh ekstrak biji pala yang bebas miristisin dan safrol. Berdasarkan penelitian sebelumnya, ekstrak biji pala bebas miristisin dan safrol (PBMS) memiliki aktivitas sebagai antihiperglikemik dan antidislipidemik. Penelitian ini bertujuan membuat formula sediaan tablet dari ekstrak PBMS yang memenuhi persyaratan dan memiliki aktivitas sebagai antihiperglikemik dan antidislipidemik. Metode penelitian eksperimental meliputi ekstraksi, pemisahan miristisin dan safrol, formulasi sediaan tablet dengan perbedaan variasi konsentrasi PVP yaitu 2%, 3%, 4%, dan 5%, evaluasi sediaan tablet, dan pengujian aktivitas sediaan tablet. Hasil penelitian menujukkan bahwa sediaan tablet yang dibuat memenuhi persyaratan kualitas tablet. Berdasarkan data hasil kromatografi lapis tipis (KLT), zat berkhasiat dari ekstrak PBMS masih terdapat dalam sediaan tablet setelah melalui tahapan formulasi. Berdasarkan pertimbangan klinis untuk terapi diabetes melitus maka diperlukan tablet yang dapat segera hancur agar dapat segera memberikan aktivitas. Tablet yang memiliki waktu hancur tercepat adalah tablet formula 1 (F1) dengan waktu hancur 6,71 menit.
Ibuprofen merupakan zat aktif yang memiliki khasiat sebagai analgesik, antipiretik, mengobati gejala rheumatoid arthritis, osteoarthritis, dan dysmenorrhea. Penelitian tentang formulasi tablet ibuprofen bertujuan untuk memperoleh sediaan tablet ibuprofen menggunakan disintegran Sheffield TM Tabletting System DTHV dan DTFD dengan metode kempa langsung yang memenuhi persyaratan Farmakope Indonesia dan United States Pharmacopeia. Tablet ibuprofen dibuat dengan metode kempa langsung menggunakan Sheffield TM Tabletting System DTHV dan DTFD serta Avicel PH 102 sebagai disintegran pembanding dengan variasi konsentrasi masing-masing disintegran sebesar 50%, 55%, dan 60%. Evaluasi tablet meliputi keseragaman bobot, diameter, ketebalan, kekerasan, friabilitas, keseragaman kadar, dan disolusi. Pengujian disolusi in vitro menggunakan alat disolusi tipe II (dayung) dengan medium larutan dapar fosfat (pH 7,2). Hasil pengujian waktu hancur dan disolusi tablet menunjukkan bahwa pada tablet ibuprofen yang menggunakan Sheffield TM Tabletting System DTHV memiliki waktu hancur dan zat aktif terlarut yang memenuhi persyaratan Farmakope Indonesia dan United States Pharmacopeia.
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