EFFECT OF MILLING PROCESS ON PHYSICAL CHARACTERISTICS OF FENOFIBRATE

Particle size is ones of the most important characteristic of active drug substance that affects solubility and bioavailability. Fenofibrate, as a class II drug based on biopharmaceutical classification system, which has poor aqueous solubility has been chosen to be drug model of particle size reduction.. Fenofibrate was mixed with mannitol as stabilizer with the ratio 1:9 in physical mixture form. The size reduction was conducted by a ball mills, with the milling rate of 100, 200 and 300 rpm, respectively. Characterization of the solid dispersion was analyzed by organoleptic and instrumental method. The instrumental tools used were Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC) which showed that there was no changes happen in fenofibrate molecule during milling process. Scanning Electron Microscope results showed that fenofibrate-mannitol was produce non-spherical forms. Milling rate improvement produce smaller size of particle with rough morphology that decrease the flow properties. Based on the solubility test and reflected in UV/Vis spectra, it showed that particle size reduction with 200 rpm milling rate determined 3 times higher of aborsbance value compared with pure fenofibrate

PENGARUH VARIASI PEMANIS TERHADAP FORMULASI GRANUL EFFERVESCENT (Glycine max (L.) Merr.) VARIETAS DETAM 1

Telah dilakukan penelitian yang bertujuan untuk mengetahui pengaruh pemanis terhadap karakteristik fisik granul effervescent biji kedelai (Glycine max (L.) Merr.) varietas Detam I dan melihat pengaruh formulasi terhadap kadar fenolik total pada serbuk dan granul effervescent. Pembuatan granul effervescent dilakukan dengan metode granulasi kering yang dibuat dalam tiga fomula yang berbeda, formula 1 dengan variasi pemanis aspartam, formula 2 dengan pemanis siklamat, dan formula 3 dengan pemanis sukralosa. Formula 2 dipilih sebagai formula terbaik karena semua persyaratan karakteristik telah terpenuhi. Formula 1 memenuhi 5 dari 7 persyaratan karakteristik fisik, sedangkan Formula 3 memenuhi 6 dari 7 persyaratan karakteristik fisik. Penetapan kadar fenolik total pada serbuk dan granul effervescent biji kedelai (Glycine max (L.) Merr.) varietas Detam 1 dilakukan dengan metode spektrofotometri uv-vis. Kadar yang didapat pada serbuk biji kedelai (Glycine max (L.) Merr.) varietas Detam 1 adalah 9 ± 8,14mg GAE/g dan pada granul effervescent didapat 4,6 ± 1,62 mg GAE/g

FORMULATION AND STABILITY STUDY OF DETAM I SOYBEAN VARIETY (GLYCINE MAX (L.) MERR.) EFFERVESCENT GRANULES WITH DIFFERENT TYPE OF EFFERVESCENT AGENTS

The research was conducted to analyze the effect of different types and concentrations of the acid source on the physical characteristics and chemical stability of black soybean (Glycine max (L.) Merr.) Detam I variety effervescent granules. Effervescent granules were made in three different acid sources, which are  15% citric acid for formula I, a mixture of 5% citric acid and 10% tartaric acid for formula II and a mixture of 8% citric acid and 16% tartaric acid for formula III, respectively. The granules’ physical characteristics were obtained by particle size distribution, specific density, bulk density, moisture content, flow time, angle of repose, and effervescent time. Total phenolic content was evaluated for 28 days and the samples were collected at 0, 1, 4, 7, 14, 21, and 28 days. The sample was then measured using a visible spectrophotometric method at 505.5 nm wavelength. The results showed that granule effervescent with formula III was selected as the best formula in all parameters measured, except on the particle size distribution result. In addition,  total phenolic in the formula I was the highest content with a better stability profile, compared to formula II and III. It showed that the formula with a combination of 8% citric acid: 16% tartaric acid is the most optimum formula physically, even for further research, adsorbent use or binder ratio in the formula, and moisture resistant of the primary packaging must also be considered.    

Spray Drying of Asiatic Acid-Palm Oil in Maltodextrin: Improving the Nanoemulsion Characteristics

Combination of Asiatic acid (AA) and palm oil (PO) is promising to be developed. However, both have low solubility, low absorption, rapid metabolism, low bioavailability, and high oxidation which need to be improved in order to provide good activity. Thus, nanoemulsion formulation followed by spray drying were optimized to enhance the physical and chemical characteristics of the products. Lecithin (L), poloxamer188 (P), span80 (S), tween80 (T) were used as surfactants to form nanoemulsion and maltodextrin (M) was used as spray dried matrix component. Different amounts of maltodextrin were optimized at low (M1), medium (M2), and high (M3) levels. Characterization and evaluation were carried out on products, including particle size, morphology, product recovery (yield), drug content, solubility, and dissolution rate. The characterization results showed that nanoemulsion was successfully prepared and spray dried microparticles with a good physical form were obtained. The microparticles could be rapidly redispersed to form size of 149.0 – 271.1 nm with the zeta potential value lower than -30mV. Both physical and chemical stability of the microparticles showed no significant difference after 6-month storage. Lecithin-Tween-medium Maltodextrin (LTM2) formula showed the most optimum results with good physical characteristics and a high dissolution rate. In vitro release profile of LTM2 showed area under the curve (AUC) and dissolution efficiency at 180min values of 14725.10 +- 480.60 and 81.81 +- 2.67%, respectively. It could be concluded that spray dried microparticles of AA-PO nanoemulsion formulation improved the physical and chemical characteristics of both compounds presumably suitable good bioavailability and activity

IMPACTS OF BINDER AND DISINTEGRANT ON DETAM II SOYBEAN (GLYCINE MAX (L.) MERR) TABLET MADE BY DRY GRANULATION

Keywords: Detam II black soybean (Glycine max (L.) Merr), Tablet, Binder, Disintegrant, Disintegration time Black soybean (Glycine max L. Merr) Detam II Variety has a scavenging activity and total phenolic compound higher than yellow soybean. As a natural compound, the flow properties of black soybean (Glycine max (L.) Merr) Detam II powder is poor due to its high content of moisture, so it must be made by dry granulation method. Dry binder and disintegrant have opposite functions on tablets formula where one serves to increase consolidation between particles while other accelerate the disintegration time as the rate limiting step of dissolution. The effects of disintegrant and dry binder variation on the physical characteristics of black soybean tablets have been observed. The variations of polyvinylpyrrolidone (PVP)-K30 combined with Plasdone S-630 were used as binders, while sodium starch glycolate (SSG) was used as a disintegrant. Approximately 4% of PVP-K30 as a single binder in the formula component provides better hardness and friability value of tablets, but the disintegration time was longer than other formulas. The amount of SSG used was increased to 4 and 8%, respectively in the formula component. 4% was the ideal amount of SSG as a disintegrant to get the best physical tablet characteristics and also disintegration time, about 4.45 minutes. Increasing the amount of SSG has no significant effect on the disintegration time even tends to slow down

Formulation And Physical Characteristics Of Detam II Soybean (Glycine Max (L.) Merr) Tablet With Various Concentration Of Silicon Dioxide And Magnesium Stearate

Objective: This research was conducted to obtain several formulation and evaluate the physical characteristics of the soybean Glycine max (L.) Merr Detam II variety tablets. Methods: Detam II varieties of soybean (G. max (L.) Merr.) were cleaned and grinded into 30 mesh-sized powder. Weighed soybean powder and internal phase of excipients (based on the formula) mixed by a Y-cone mixer until homogeneous, and then continue with dry granulation process. Granules formed, then sieved into 16 mesh size, and then, the characteristics examined. Dried granules then mixed with magnesium stearate and silicon dioxide using a drum mixer and compressed into tablets. Physical characteristics of tablets measured at 0, 4, 7, 14, 21, and 28 days. Results: Evaluation was done for particle size distribution, moisture content (MC), flow properties, weight uniformity, friability, hardness, and disintegration time. Dry granulation was the best method to improve the characteristics of soybean powder with poor compressibility, poor flowability, and hygroscopic. Flow properties of the granules became better for Formula II and III by adding the concentration of silicon dioxide. The formulas also showed the good uniformity of weight, size, MC, friability, and disintegration time. Reducing the lubricant until 0, 5% of the formula made differences in friability, hardness, and disintegration time better than another formula. Conclusion: The result of this research indicates that differences in silicon dioxide and magnesium stearate composition of the formula can affect the physical characteristics of soybean (G. max (L.) Merr.) tablets

FORMULAI FLOATING TABLET MENGGUNAKAN VARIASI KONSENTRASI HPMCK100M TERHADAP KEMAMPUAN MENGAPUNG DAN PROFIL DISOLUSI TABLET RANITIDINE HCL

In this study, a sustained release floating tablet formula is designed with Ranitidine HCl as a model drug. The aim of this study is to obtain the optimum concentration of HPMC K100M as the primary gelling polymer for floating tablet. This sustained release floating tablet is supposed to decrease release rate of the drug, thereby it prolong the gastric residence time. Tablets were prepared by direct compression technique, and the tablet weight uniformity, hardness, friability, assay of the active ingredient, floating lag time, floating duration time, and the drug release through dissolution test for 12 hours in 0,1 N HCl media were evaluated. The result showed the entire formula take less than 1 minute to buoyant, and are able to remain for more than 12 hours. Otherwise, dissolution efficiency (%ED) was significantly decreased with the addition of HPMC K100M F1 15%, F2 20%, F3 25%, and F4 30% were 90,56%; 84,05%; 77,47%; and 73,57% respectively

Hubungan Antar Faktor Penyebab Human Error Terhadap Jumlah Penyimpangan Produk Blister Di PT. XXX

Human error merupakan penyebab utama terjadinya penyimpangan mutu produk blister di PT. XXX, yang dipengaruhi oleh faktor personil dan metode kerja. Penelitian ini bertujuan untuk menganalisis hubungan level kualifikasi personil (tim produksi blister) dan jumlah produk blister serta lama produksi (mesin blister Z) terhadap peningkatan penyimpangan produk blister di PT. XXX (2015-2017). Penelitian ini bersifat deskriptif observasional (retrospektif) menggunakan analisis regresi linier 2 variabel dan multi variabel. Hasil analisis uji t antara level kualifikasi personil dan penyimpangan produk blister, p=0,041 (p<0,05) menunjukkan hubungan signifikan antara kedua variabel tersebut. Hasil analisis uji t antara jumlah produk blister dan penyimpangan produk blister, p=0,164 (p>0,05) menunjukkan tidak terdapat hubungan signifikan antara kedua variabel tersebut. Hasil analisis uji t antara lama produksi (mesin blister Z) dan penyimpangan produk blister, p=0,542 (p>0,05) menunjukkan tidak terdapat hubungan signifikan antara kedua variabel tersebut. Hasil analisis uji F menunjukkan terdapat hubungan signifikan antara level kualifikasi personil (tim produksi blister) dan jumlah produk blister serta lama produksi (mesin blister Z) terhadap peningkatan penyimpangan produk blister (p=0,000; p<0,05)

Formulasi Granul Minuman Fungsional Kombinasi Ekstrak Etanol Daun Jambu Biji (Psidium guajava) dan Ekstrak Etanol Biji Klabet (Trigonella foenum-graecum)

Minuman fungsional diharapkan dapat memberikan manfaat kesehatan diantaranya meningkatkan imunitas, membantu pencernaan, menurunkan kolesterol, mengandung serat tinggi, dan dapat menurunkan kadar gula. Daun jambu biji dan biji klabet berpotensi untuk dikembangkan menjadi minuman fungsinal terutama karena aktivitas antioksidannya yang tinggi. Tujuan penelitian ini adalah untuk mendapatkan formula terbaik granul minuman fungsional kombinasi ekstrak etanol daun jambu biji dengan ekstrak etanol biji klabet yang memenuhi spesifikasi dan diterima oleh panelis pada pegujian hedonik. Granul minuman fungsional dibuat dalam empat formula dengan berbagai rasio ekstrak etanol daun jambu biji dibanding ekstrak etanol biji klabet, yaitu: Formula I (3%:0%), Formula II (3%:1%), Formula III (3%:2%), dan Formula IV (3%:3%). Granul diformulasi dengan metode granulasi basah, kemudian dievaluasi karakteristik fisiknya. Hasil uji karakteristik fisik granul menunjukkan rerata kandungan lembab 1,35-1,81%; fines 2,36-6,26%; kecepatan alir 6,99-8,92 g/detik; sudut istirahat 31,60-34,70°; indeks kompresibilitas 17,38-20,42%; rasio Hausner 1,21-1,25. Uji hedonik menunjukkan rerata skor parameter warna (3,32-3,76), bau (3,32-4,00), dan rasa (3,60-4,32). Formula terbaik yang memenuhi spesifikasi dan paling diterima oleh panelis pada pegujian hedonik adalah formula IV