Pengaruh Perbedaan Perbandingan Kosnsentrasi Surfaktan dan Kosurfaktan 45:5, 40:10, 35:15 terhadap Stabilitas Fisik Self- Nanoemulsifying Drug Delivery Systems (Snedds) Atenolol dengan Fase Minyak Zaitun (Olive Oil)

ABSTRAK-Penelitian ini membahas tentang bagaimana cara meningkatkan kelarutan serta bioavailabilitas atenolol di dalam tubuh dengan memperkecil ukuran partikel atenolol menjadi bentuk nano (SNEDDS). Pada penelitian ini dibuat SNEDDS atenolol dengan tiga formula yang berbeda, masing-masing dengan jumlah bahan aktif (2%) dan minyak (49%) yang sama, namun dengan kosentrasi surfaktan dan kosurfaktan yang berbeda-beda, yaitu formula satu dengan perbandingan 45:5, formula dua dengan perbandingan 40:10, serta formula tiga dengan perbandingan 35:15. Kemudian, ketiga formula tersebut akan dievaluasi karakteristik fisiknya yang meliputi pengamatan organoleptis, ukuran partikel, % transmisi, polydispersity index, zeta potensial, robustness to dilution serta viskositas. Kemudian dilanjutkan dengan dilakukan uji stabilitas fisik SNEDDS dengan cara sentrifugasi dan siklus heating/cooling. Berdasarkan penelitian ini didapatkan hasil bahwa perbedaan konsentrasi surfaktan dan kosurfaktan tidak berpengaruh terhadap karakteristik fisik SNEDDS yang terbentuk, serta SNEDDS yang tidak stabil akibat atenolol yang tidak larut ke dalam pembawa SNEDDS (konsentrasi surfaktan dan kosurfaktan belum cukup kuat untuk meingkatkan kelarutan atenolol).Kata kunci: atenolol, bioavailabilitas, nanopartikel, SNEDDSABSTRACT-This thesis is going to discuss about how to increase the solubility and bioavailability of Atenolol by reducing the particle size of Atenolol to form a nanoparticle (SNEDDS). In this thesis, the Atenolol SNEDDS were made into three different formulas, which have the same amount of active pharmaceutical ingredient (2%) and oil (49%) although the amount of surfactant and cosurfactant were all different, which were 45:5 for formula number one, 40:10 for formula number two, and 35:15 for formula number three. Furthermore, each of the three formulas were evaluated for its physical characteristics that include organoleptic observation, particle size, percent transmission, polydispersity index, zeta potential, robustness to dilution and viscosity. Soon after, the process were continued to the physical stability testing, using centrifugation method and heating/cooling cycle. The results that obtained from this thesis are that the differences in the concentration of surfactant and co-surfactant do not influence any of the physical characteristics of the SNEDDS, and the SNEDDS that’s been formed are physically unstable because the Atenolol doesn’t fully dissolved in the SNEEDS carrier (the surfactant and co-surfactant concentration aren’t strong enough to increase the solubility of Atenolol).Keywords: atenolol, bioavailability, nanoparticle, SNEDDS

Formulation and physical stability test of oleanolic acid cream and gel

Plantago major has been empirically used for wound healing. One of its chemical compounds, oleanolic acid, exhibited wound healing activity on hyperglycemic rats. The aims of this study were to (1) formulate oleanolic acid into topical dosage forms i.e. cream and gel; and (2) evaluate the physical stability of the products. Oleanolic acid was formulated into the dosage forms using stearic acid, isopropyl palmitate and cetyl alcohol as the cream base and carbomer as the gel base. Cream and gel were then subjected into accelerated (40±2°C/75±5% RH) and room temperature (27±2°C/73±5% RH) stability test for six weeks. Physical stability was determined using parameters of visual appearance, specific gravity, viscosity and flow properties, for both gel and cream, as well as the type of emulsion and particle size for the cream. Data analysis were performed using one-way ANOVA and paired t-test. It is concluded that gel and cream of oleanolic acid were able to maintain their visual appearance, specific gravity, viscosity and flow properties during six weeks of storage. In addition, oleanolic acid cream could also maintain its particle size and type of emulsion during testing.

Formulation and physical stability test of oleanolic acid cream and gel

Plantago major has been empirically used for wound healing. One of its chemical compounds, oleanolic acid, exhibited wound healing activity on hyperglycemic rats. This study aimed to (1) formulate oleanolic acid into topical dosage forms, i.e., cream and gel and (2) evaluate the physical stability of the products. Oleanolic acid was formulated into the dosage forms using stearic acid, isopropyl palmitate, and cetyl alcohol as the cream base and carbomer as the gel base. The cream and gel were then evaluated with accelerated stability test (40±2°C/75±5% RH) and stability test at room temperature (27±2°C/73±5% RH) for six weeks. The physical stability was determined using the following parameters: the visual appearance, density, viscosity, and flow properties of cream and gel, as well as the emulsion type and particle size of the cream. Data analysis were performed using one sample t-test and paired t-test. The results showed that the oleanolic acid cream and gel were able to maintain their visual appearance, density, viscosity, and flow properties during the six-week storage. Also, the oleanolic acid cream was able to keep its particle size and emulsion type during the tests

Pengaruh Variasi Komponen Asam-Basa terhadap Stabilitas Fisik Sediaan Effervescent Ekstrak Rimpang Temulawak (Curcuma Xanthorrhiza Roxb.) selama masa Penyimpanan Dua Bulan

ABSTRAK-Kurkumin merupakan senyawa pada temulawak (Curcuma xanthorrhiza Roxb.) yang memiliki aksi antiinflamasi yang bekerja dengan menurunkan aktivitas sekresi TNF-α. Kurkumin memiliki rasa yang pahit jika dikonsumsi. Bentuk sediaan Effervescent dengan ekstrak kental dijadikan inovasi untuk mengatasi masalah tersebut dengan memproduksi CO2. Ekstrak kental didapat dari Materia Medika Batu, Malang. Granul dibuat dengan metode granulasi basah, dengan ekstrak kental dicampurkan dengan fase asam. Untuk mengetahui stabilitas granul Effervescent dilakukan uji stabilitas selama 2 bulan, pada penelitian ini digunakan tiga rasio yang berbeda dengan menggunakan asam sitrat, asam tartrat, dan natrium bikarbonat, yaitu 1:2:3,4; 1:1:2,9; 2:1:3,4. Granul dievaluasi karakteristik fisik sebelum dan sesudah direkonstitusi. Hasil evaluasi karakteristik fisik dilakukan dengan metode ANOVA One Way, menunjukkan bahwa rasio komponen asam dan basa stabil pada tinggi buih dan Effervescent time. Evaluasi yang dilakukan pada tiga formula, didapatkan bahwa formula II memiliki formula terbaik pada titik 4 dengan kecepatan alir 5,08 g/detik ± 0,02; sudut istirahat 32,20o ± 2,01; kandungan lembab 2,36 % ± 0,09; %fines 0,00% dan rata-rata ukuran partikel 51,74%; Rasio Haussner 1,29 ± 0,02; tinggi buih 5,40 cm ± 0,53; Effervescent time 223,55 detik ± 20,93; pH 5,45 ± 0,03; viskositas 33,77 cPs ± 5,77.Kata kunci: temulawak, kurkumin, granul Effervescent, rasio komponen asam dan basa, karakteristik fisik dan pHABSTRACT-Curcumin is a compound in curcuma (Curcuma xanthorrhiza Roxb.) which has an anti-inflammatory action that works by reducing TNF-α secretion. Curcumin has a bitter taste when consumed. The Effervescent form of the thick extract of this compound is used as an innovation to overcome this problem by producing CO2. The thick extract was obtained from Materia Medika Batu, Malang. Granules were made by wet granulation method, with thick extract mixed with acid phase. To determine the stability of Effervescent granules, the stability test was carried out for 2 months. This study used three different ratios of citric acid, tartrate acid, and sodium bicarbonate, namely 1:2:3,4; 1:1:2,9; 2:1:3,4. Granules were evaluated for physical characteristics before and after reconstitution. The results analysis of the evaluation of physical characteristics were carried out using the One Way ANOVA method, indicating that the ratio of acidic and basic components was stable against in foam height and Effervescent time. The evaluation was carried out on three formulas, and it was deduced that formula II was the best formula at point 4 with a flow rate of 5.08 g/s ± 0.02; angle of repose 32.20º ± 2.01; moisture content 2.36% ± 0.09; %fines 0.00% and average particle size 51.74%; Haussner Ratio 1.29 ± 0.02; foam height 5.40 cm ± 0.53;Effervescent time of 223.55 seconds ± 20.93; pH 5.45 ± 0.03; viscosity of 33.77 cPs ± 5.77.Keywords: curcuma, curcumin, Effervescent granule, acid-base component ratio, physical characteristics and p

Pengaruh Variasi Komponen Asam-Basa terhadap Stabilitas Fisik Sediaan Effervescent Ekstrak Rimpang Temulawak (Curcuma Xanthorrhiza Roxb.) selama masa Penyimpanan Dua Bulan

ABSTRAK-Kurkumin merupakan senyawa pada temulawak (Curcuma xanthorrhiza Roxb.) yang memiliki aksi antiinflamasi yang bekerja dengan menurunkan aktivitas sekresi TNF-α. Kurkumin memiliki rasa yang pahit jika dikonsumsi. Bentuk sediaan Effervescent dengan ekstrak kental dijadikan inovasi untuk mengatasi masalah tersebut dengan memproduksi CO2. Ekstrak kental didapat dari Materia Medika Batu, Malang. Granul dibuat dengan metode granulasi basah, dengan ekstrak kental dicampurkan dengan fase asam. Untuk mengetahui stabilitas granul Effervescent dilakukan uji stabilitas selama 2 bulan, pada penelitian ini digunakan tiga rasio yang berbeda dengan menggunakan asam sitrat, asam tartrat, dan natrium bikarbonat, yaitu 1:2:3,4; 1:1:2,9; 2:1:3,4. Granul dievaluasi karakteristik fisik sebelum dan sesudah direkonstitusi. Hasil evaluasi karakteristik fisik dilakukan dengan metode ANOVA One Way, menunjukkan bahwa rasio komponen asam dan basa stabil pada tinggi buih dan Effervescent time. Evaluasi yang dilakukan pada tiga formula, didapatkan bahwa formula II memiliki formula terbaik pada titik 4 dengan kecepatan alir 5,08 g/detik ± 0,02; sudut istirahat 32,20o ± 2,01; kandungan lembab 2,36 % ± 0,09; %fines 0,00% dan rata-rata ukuran partikel 51,74%; Rasio Haussner 1,29 ± 0,02; tinggi buih 5,40 cm ± 0,53; Effervescent time 223,55 detik ± 20,93; pH 5,45 ± 0,03; viskositas 33,77 cPs ± 5,77.Kata kunci: temulawak, kurkumin, granul Effervescent, rasio komponen asam dan basa, karakteristik fisik dan pHABSTRACT-Curcumin is a compound in curcuma (Curcuma xanthorrhiza Roxb.) which has an anti-inflammatory action that works by reducing TNF-α secretion. Curcumin has a bitter taste when consumed. The Effervescent form of the thick extract of this compound is used as an innovation to overcome this problem by producing CO2. The thick extract was obtained from Materia Medika Batu, Malang. Granules were made by wet granulation method, with thick extract mixed with acid phase. To determine the stability of Effervescent granules, the stability test was carried out for 2 months. This study used three different ratios of citric acid, tartrate acid, and sodium bicarbonate, namely 1:2:3,4; 1:1:2,9; 2:1:3,4. Granules were evaluated for physical characteristics before and after reconstitution. The results analysis of the evaluation of physical characteristics were carried out using the One Way ANOVA method, indicating that the ratio of acidic and basic components was stable against in foam height and Effervescent time. The evaluation was carried out on three formulas, and it was deduced that formula II was the best formula at point 4 with a flow rate of 5.08 g/s ± 0.02; angle of repose 32.20º ± 2.01; moisture content 2.36% ± 0.09; %fines 0.00% and average particle size 51.74%; Haussner Ratio 1.29 ± 0.02; foam height 5.40 cm ± 0.53;Effervescent time of 223.55 seconds ± 20.93; pH 5.45 ± 0.03; viscosity of 33.77 cPs ± 5.77.Keywords: curcuma, curcumin, Effervescent granule, acid-base component ratio, physical characteristics and p

Formulasi dan Uji Stabilitas Fisik Krim dan Gel Asam Oleanolat

Latar belakang: Plantago major (daun sendok) secara empiris telah digunakan untuk mengobati luka. Salah satu kandungan kimianya yaitu asam oleanolat telah terbukti memiliki aktivitas wound healing pada tikus hiperglikemik sebagai model luka ulkus diabetik. Tujuan: Penelitian ini bertujuan untuk melakukan formulasi asam oleanolat menjadi bentuk sediaan krim dan gel serta menguji stabilitas fisiknya. Metode: Asam oleanolat diformulasi menjadi bentuk sediaan krim dan gel dengan asam stearat, isopropil palmitat dan cetyl alcohol sebagai basis krim serta karbomer sebagai basis gel. Krim dan gel asam oleanolat kemudian dilakukan uji stabilitas dipercepat (climatic chamber 40±2°C/RH 75±5%) dan uji stabilitas pada suhu ruang (27±2°C/RH 73±5%) selama 6 minggu. Parameter uji stabilitas fisik yang ditentukan adalah organoleptis sediaan, berat jenis, viskositas dan sifat alir, untuk gel maupun krim, serta tipe emulsi dan ukuran partikel khusus untuk krim. Analisis data dilakukan dengan menggunakan one-way ANOVA, paired t-test dan independent t-test. Hasil penelitian: Sediaan krim asam oleanolat tidak mengalami perubahan organoleptis, berat jenis, tipe emulsi, viskositas dan sifat alir selama penyimpanan 6 minggu. Sediaan gel asam oleanolat juga tidak mengalami perubahan organoleptis, viskositas dan sifat alir selama penyimpanan 6 minggu, namun mengalami perubahan berat jenis. Kesimpulan: Krim asam oleanolat memiliki stabilitas fisik yang lebih baik dibandingkan dengan gel asam oleanolat

Formulation and pH-Physical Stability Evaluation of Gel and Cream of Plantago major Leaves Extract

Plantago major has been widely used for wound healing. This activity is supported by empirical as well as preclinical data. The aims of this study were to (1) formulate Plantago major leaves extracts (PMLE) into topical dosage forms i.e. creams and gels and; (2) evaluate the pH and physical stability of the products. The results showed that creams and gels of PMLE were able to maintain the pH, visual appearance, flow properties, droplet size, and type of emulsion under accelerated (40±2 °C; 75±5% RH for 1.5 months) as well as room temperature (27 °C; 85% RH for 1.5 months) stability testing conditions. However, viscosity of creams significantly changed under those conditions. Even though the viscosity of gels was unstable under accelerated condition, it was stable under room temperature storage. It is concluded that PMLE could be formulated into creams or gels dosage forms and further optimisation should be conducted

Formulasi dan Uji Stabilitas Fisik Krim Asam Ursolat

Asam ursolat merupakan salah satu golongan terpenoid yang memliki kemampuan untuk meningkatkan laju epitelisasi dan sebagai astringen dalam penyembuhan luka, serta memiliki aktivitas antimikroba. Untuk mengembangkan asam ursolat sebagai penyembuh luka, maka perlu diformulasikan menjadi sediaan semisolid yang terjamin kualitas dan stabilitasnya. Tujuan dari penelitian ini adalah untuk (1) memformulasikan asam ursolat ke dalam sediaan topikal krim dan (2) mengevaluasi stabilitas fisik dan pH dari sediaan tersebut. Hasil penelitian menunjukkan bahwa krim asam ursolat tidak mengalami perubahan pada parameter uji organoleptis, berat jenis, viskositas, ukuran droplet dan tipe emulsi dalam kondisi penyimpanan stabilitas dipercepat ( suhu 40±2oC; RH 75% selama 1,5 bulan), namun mengalami perubahan pH selama penyimpanan

Formulation and validation of analytical methods for ursolic acid in Plantago major gel preparations

Plantago major of the plantain family has been observed as a wound-healing plant species on account of its ursolic acid (UA) content. The study's objectives were twofold: to prepare UA gels from P. major and validate the analytical method using TLC-densitometer. Here, vacuum and open column chromatography were used to isolate UA from the methanol extract of P. major. Afterward, data on the compound’s physical properties and infrared (IR) spectroscopy, electrospray ionization mass spectrometry (ESI-MS), and Nuclear Magnetic Resonance (1H NMR, 13C NMR) results were analyzed. Carbomer and hydroxy propyl methyl cellulose (HPMC) were used as gelling agents to make the UA gel. To validate the analytical method, TLC-densitometer was performed using TLC silica gel 60 F254 plates (the stationary phase) and a mixture of toluene: ethyl acetate: formic acid (8:2:0.1, the developing solvent). The results showed that the UA gel was successfully prepared using both gelling agents and that its physical properties (i.e., visual forms, viscosity, and flow behavior) and pH values were maintained throughout the 90-day accelerated stability test (40±2°C; 75±5% RH). In addition, the method validation results indicated compliance with relevant parameters: linearity (r=0.998), limit of detection (4.55 ng/spot) and limit of quantification (15.17 ng/spot), recovery (95.04-116.82%), intraday precision (RSD=1.24–1.96%) and interday precision (RSD=6.29%). Overall, the UA gel is stable for 90 days (accelerated stability test), and the TLC-densitometry proposed in the research can be used to identify and measure the chemical content of a gel preparation

Karakterisasi dan Stabilitas Fisik Mikroemulsi Tipe A/M dengan Berbagai Fase Minyak

Pada penelitian ini dilakukan formulasi, karakterisasi dan stabilitas fisik sediaan mikroemulsi tipe air dalam minyak. Minyak yang digunakan sebagai fase minyak dalam pembuatan mikroemulsi adalah VCO, minyak kelapa sawit , minyak zaitun dan minyak kedelai , fase air aquademineralisata, Span® 80 dan Tween® 80 sebagai surfaktan dan propanol sebagai kosurfaktan. Setiap formula dilakukan 3 replikasi dan ditentukan karakteristik fisik yang meliputi pengamatan organoleptis, pengukuran berat jenis, pengukuran droplet, pengukuran viskositas dan sifat alir, dan pengukuran pH. Penentuan karakteristik fisik dilakukan pada saat awal terbentuk mikroemulsi dan setelah penyimpanan selama 5 minggu dalam suhu kamar. Selain itu, juga dilakukan uji stabilitas fisik yang meliputi uji sentrifugasi dengan kecepatan 10.000 rpm selama 30 menit, uji freeze-thaw selama 6 siklus, dan uji heating stability dengan oven suhu 60ºC, 70ºC, 80ºC, 90ºC, dan 100ºC selama 5 jam. Dari data yang didapatkan dilakukan analisis statistik menggunakan metode t-Test dan one way ANOVA. Dari penentuan karakteristik dan stabilitas fisik yang telah dilakukan didapatkan hasil bahwa mikroemulsi dengan minyak VCO, minyak kelapa sawit dan minyak kedelai memiliki karakteristik dan stabilitas fisik yang lebih baik dibandingkan dengan mikroemulsi dengan minyak zaitun