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The capability of Several Population-based Approach Software to Analyze Sparse Drug Plasma Concentration Data after Intra-Venous Bolus Injection Akhmad Kharis Nugroho; Lukman Hakim
Indonesian Journal of Pharmacy Vol 30 No 4, 2019
Publisher : Faculty of Pharmacy Universitas Gadjah Mada, Yogyakarta, Skip Utara, 55281, Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (957.346 KB) | DOI: 10.14499/indonesianjpharm30iss4pp293

Abstract

Monolix, NONMEM, and WinBUGS-PKBUGS are among available software package for population-based modeling. The sparse condition of drug plasma concentration versus time (Cp-time) data is prevalent in clinically based studies involving patients. It is not ethical in this case, to collect a many and large volumes of blood samples. This study was aimed to simulate the capability of Monolix, NONMEM, and WinBUGS-PKBUGS to analyze very sparse Cp-time data after an intravenous bolus drug administration and to estimate the minimum number of Cp-time data required for an adequate analysis. Data of Cp-time were obtained based on simulation using the pharmacokinetic one-compartment open model following an intravenous bolus administration of 50 mg of a hypothetical drug. In this respect, six random values of k (rate constant of elimination) and Vd (volume of distribution) with mean and standard deviation values of 0.3 ±0.1 per hour and 30 ± 10 L, respectively, were used to create simulated Cp-time data of 6 subjects. Simulated Cp-time data in each subject were randomly ranked to choose data based on the intended number of samples in each subject. Several sparse Cp-time data scenarios, starting from a very limited state, i.e., with a total of 6 Cp-time data (1 datum per subject) to a rich situation with 48 Cp data (8 data per subject), were examined.The goodness of fit evaluations, as well as the similarity of individual values of k and Vd to the respective real values  (p>0.05), indicate that nonlinear-mixed-effect-model using Monolix, NONMEM and WinBUGS-PKBUGS can appropriately describe sparse Cp-time data even with only 2 data per subject. This fact is an important finding to support the demand of analytical tool for a limited number of Cp-time data such as obtained in therapeutic drug monitoring event.
Profil Pelepasan Andrografolid Granul Kombinasi Ekstrak Terpurifikasi Herba Pegagan (Centeella Asiatica) Dan Sambiloto (Andrographis Paniculata) Lina Widyastuti; Akhmad Kharis Nugroho
JURNAL FARMASI DAN ILMU KEFARMASIAN INDONESIA Vol. 3 No. 2 (2016): JURNAL FARMASI DAN ILMU KEFARMASIAN INDONESIA
Publisher : Universitas Airlangga

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (303.454 KB) | DOI: 10.20473/jfiki.v3i22016.58-61

Abstract

Pendahuluan: Andrografolid merupakan senyawa yang sukar larut dalam air, penentuan jumlah dan profil pelepasan andrografolid dari bentuk sediaan perlu dilakukan. Tujuan: Penelitian ini dilakukan untuk menentukan jumlah dan profil andrografolid yang dilepaskan dari formula granul kombinasi ekstrak terpurifikasi herba pegagan dan herba sambiloto. Hal tersebut untuk memastikan eksipien tidak mengikat zat aktif. Metode: Uji pelepasan dilakukan dengan melakukan uji disolusi menggunakan media dapar asetat pH 4,5. Hasil disolusi granul kombinasi ekstrak terpurifikasi herba pegagan dan herba sambiloto ditentukan menggunakan KLT-densitometri. Hasil: Hasil perhitungan efisiensi disolusi (ED60) sebesar 75,00% ± 1,33. Profil disolusi ditentukan dengan regresi nonlinear dengan pendekatan orde nol, orde 1, Higuchi, Hixon Crowell dan Korsmeyer Peppas. Mekanisme penentuan profil disolusi dari pelepasanan andrografolid dilihat secara visual dari kesesuaian hasil prediksi solver (QPrediksi) dan hasil percobaan (Qobservasi) dengan melihat garis identitas. Kurva dari suatu model yang mendekati garis identitas merupakan gambaran mekanisme pelepasan andrografolid yang dibentuk dengan pendekatan tersebut. Kurva dengan pendekatan Korsmeyer Peppas terlihat lebih dekat dengan garis identitas bila dibandingkan dengan 4 model pendekatan yang lain. Berdasarkan perhitungan regresi nonlinear, pelepasan andrografolid dikontrol dengan mekanisme difusi matriks, yang berarti pelepasan andrografolid dari granul terjadi karena adanya pengikisan lapisan terluar karena Avicel PH 101 terhidrasi dengan cepat. Dengan menggunakan persamaan Korsmeyer-Peppas mekanisme pelepasan andrografolid mengikuti hukum difusi Fick dengan nilai n = 0,320 (< 0,45). Kesimpulan: Jumlah dan profil pelepasan andrografolid dari granul adalah hasil penelitian yang dapat dijadikan suatu referensi untuk menentukan jumlah ekstrak yang dipakai dalam formulasi.
Formulasi Nanopartikel Losartan dengan Pembawa Kitosan AKHMAD KHARIS NUGROHO; NURI ARI EFIANA; RONNY MARTIEN
JURNAL ILMU KEFARMASIAN INDONESIA Vol 11 No 1 (2013): JIFI
Publisher : Fakultas Farmasi Universitas Pancasila

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Abstract

Nanoparticle formulation is important for systemic drug delivery via several routes. This research was aimed to establish optimal formation of chitosan nanoparticle formulation with losartan, an antihypertension known as an angiotensin II receptor antagonist. Ionic gelation method was used. Formulation was established in 2 steps. Firstly, determination of the best losartan and chitosan concentrations which can produce physically stable nanoparticles without precipitation, at room temperature within 25 days. Secondly, optimization of the process by factorial design method of two factors, including pH (4.0 and 5.0) and the stirring rate (350 and 700 rpm), with the loading capacity of the nanoparticle as the observed response. The obtained nanoparticles were evaluated further for its particle size and zeta potential. The physichal stability tests indicated that two nanoparticle formulations containing losartan-chitosan of (14 mg% : 35 mg%), and losartan-chitosan of (21 mg% : 35 mg%) were stable. The factorial design studies suggested that pH 4 and the stirring rate of 350 rpm were the optimal conditions which produced the highest loading capacity (47,7%). The particle size and zeta potential of the stable nanoparticle were 290.3±52.6 nm and +50.8 ±4.8 mV respectively.
Pengaruh Purifikasi n-Heksana pada Serbuk Simplisia terhadap Kadar Asiatikosida, Penangkapan Radikal Bebas dan Kadar Fenol Total Ekstrak Etanolik Herba Pegagan (Centella asiatica (L.) Urban) AGATHA BUDI SUSIANA LESTARI; ACHMAD FUDHOLI; AKHMAD KHARIS NUGROHO; ERNA PRAWITA SETYOWATI
JURNAL ILMU KEFARMASIAN INDONESIA Vol 13 No 1 (2015): JIFI
Publisher : Fakultas Farmasi Universitas Pancasila

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Abstract

It has been proven that gotu kola (Centella asiatica (L.) Urban) have an antioxidant activity that make it possible to use in preventing degenerative illness. The aims of this study are to find the effect of n-hexane purification before maceration on asiaticoside content, free radical scavenging activity and total phenolic content of gotu kola ethanolic extract. The gotu kola extract was made by maceration process using the mix of ethanol and aquadest as solvents in different proportion, which are 100%:0% (E100), 75%:25% (E75), 50%:50% (E50), 25%:75% (E25), and 0%:100% (E0). The determination of asiaticoside content in gotu kola ethanolic extract was measured using Thin Layer Chromatography (TLC) Densitometry method, free radical scavenging activity was measured using diphenylpicryl hydrazyl (DPPH) and defined by parameter of IC , and total phenolic content was defined by equivalency of galic acid using Folin-Ciocalteau. The results show that the hexane purification would increasing total phenolic content significantly in ethanolic extract which extracted with solvents in proportion of ethanol:aquades 75%:25% (E75), 50%:50% (E50), and 25%:75% (E25), but not significant in decreasing of IC . Statistically, n-hexane purification was also not significant to increasing asiaticoside content in gotu kola ethanolic extract.
Prediksi Kinetika Transpor Transdermal Propranolol HCl dengan Program WinSAAM LUCIA HENDRIATI; AKHMAD KHARIS NUGROHO
JURNAL ILMU KEFARMASIAN INDONESIA Vol 9 No 1 (2011): JIFI
Publisher : Fakultas Farmasi Universitas Pancasila

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Abstract

Transdermal transport was an alternate to propranolol HCl delivery to overcome the low bioavailability by oral route. Kinetics of transdermal transport can be predicted by software WinSAAM. The aim of this research was to know kinetics of propranolol HCl transdermal transport with the present of enhancer oleic acid, propylene glycol and iontophoretics. Propranolol HCl transdermal transport was examined through the hairless rat as membrane on the vertical diffusion cell in the in vitro permeation. Enhancement methode used was oleic acid in propylene glycol and iontophoretics at varying concentrations. The donor phase contained 5 mg/mL propranolol HCl in citrate buffer, and the acceptor phase contained phosphate buffer saline at pH 7.4. Results of propranolol HCl transdermal transport analyzed by WinSAAM software. Parameters of transdermal transport were the rate of mass transfer from donor compartement to skin (Ka), available dose to transport (AD), and the rate of mass transfer from skin to acceptor compartement (KR).The results indicated that propranolol HCl transdermal transport with the present of enhancer can be explained by three compartement model and first order kinetics. Theoretically, value of AD influenced by oleic acid, interaction of oleic acid-iontophoretics and interaction of propylene glycol-iontophoretics. Value of Ka inliuenced by iontophoretics and interaction of oleic acid-propylene glycol-iontophoretics. Value of KR induenced by iontophoretics.
Pemodelan Farmakokinetika Tablet Floating Aspirin pada Kelinci dengan PKSolver AGUS SISWANTO; ACHMAD FUDHOLI; AKHMAD KHARIS NUGROHO; SUDIBYO MARTONO
JURNAL ILMU KEFARMASIAN INDONESIA Vol 14 No 2 (2016): JIFI
Publisher : Fakultas Farmasi Universitas Pancasila

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Abstract

Aspirin selain sebagai analgetik juga efektif digunakan sebagai antiplatelet untuk profilaksis stroke. Aspirin diabsorpsi secara cepat di saluran pencernaan bagian atas terutama di bagian pertama usus halus. Formulasi dalam bentuk tablet floating diharapkan mampu memperbaiki profil farmakokinetika aspirin. Tujuan penelitian ini adalah untuk menentukan model farmakokinetika tablet floating aspirin pada kelinci dengan PKSolver. Penentuan model dengan PKSolver berdasarkan parameter: 1) visual goodness of fit (GOF) dan 2) parameter statistik yang meliputi Akaike’s information criteron (AIC) dan Schwarz criterion (SC). Berdasarkan kedua parameter tersebut menunjukkan bahwa model multiple site absorption (MAS) merupakan model terbaik untuk menjelaskan farmakokinetika tablet floating aspirin. Pelepasan dan absorpsi aspirin dari tablet floating terjadi melalui 2 tahap sehingga menghasilkan profil farmakokinetika dengan puncak ganda akibat absorpsi yang terjadi secara paralel di dalam lambung.
Pengaruh pH dan Kekuatan Ionik terhadap Profil Kelarutan Ofloksasin BUDIPRATIWI WISUDYA NINGSIH; SUWALDI SUWALDI; AKHMAD KHARIS NUGROHO
JURNAL ILMU KEFARMASIAN INDONESIA Vol 12 No 1 (2014): JIFI
Publisher : Fakultas Farmasi Universitas Pancasila

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Abstract

Ofloxacin is an antibiotic and categorized as class 2 in Biopharmaceutics Classification System (BCS). Ofloxacin solubility is dependent on pH of the solvent due to its amphoteric properties. The objectives of this research was to investigate the effects of pH and ionic strength on solubility profile of ofloxacin. Ofloxacin solubilities were measured at various pH ranged from 1.5 to 12.5 and ionic strengths from 0.01 to 0.20 respectively. Solubility experiments were carried out using shaking thermostatic-waterbath for 3 hours at a temperature of 37°C ± 1°C. Results showed that ofloxacin solubility increased at pH’s below the pKa1 value (6.08) and above the pKa2 value (8.25). However, the solubility decreased at pH’s between pKa1 and pKa2. Changing the solution pH from 6.2 to 1.5 or to 12.5 affected the solubility of ofloxacin increased about 9.96 and 8.64 times higher, respectively. Ofloxacin solubility in various ionic strengths showed that stronger ionic strength solution caused an increase in ofloxacin solubility. This mean that there was a salting in phenomena. Least-Square Fitting Analysis using Henderson-Hasselbalch equation for amphoteric compound was insufficient to describe ofloxacin solubility process in a series of pH.
Optimasi Formula Sediaan Fast Disintegrating Tablet (FDT) Ekstrak Etanolik Herba Pegagan (Centella asiatica (L.) Urb.) Agatha Budi Susiana Lestari; Achmad Fudholi; Akhmad Kharis Nugroho; Erna Prawita Setyowati
JURNAL ILMU KEFARMASIAN INDONESIA Vol 16 No 1 (2018): JIFI
Publisher : Fakultas Farmasi Universitas Pancasila

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (295.036 KB) | DOI: 10.35814/jifi.v16i1.423

Abstract

It has been proven that Centella asiatica (L.) Urb. herbs have an antioxidant activity that make it possible to used in preventing degenerative illness. Centella asiatica (L.) extract has been formulated to fast disintegrating tablet (FDT) dosage form. The aims of this study are to find the optimum formula of FDT of Centella asiatica (L.) Urb. The simplex lattice design method with 3 factors (which are mannitol as diluents, crospovidone as superdisintegrant and povidone as binder) and 2 levels of each was used. Centella asiatica (L.) Urb. extract was produce from maceration process using ethanol-water in ratio 75%:25% as a solvent. Direct compress method was used to produce the FDT. The results show that the optimum composition between excipients FDT formula could be reached, which fullfiled the physical properties parameter which are the hardness, friability and disintegration time of FDT.
EVALUATION OF THE IMPLEMENTATION OF ISO 9001 QUALITY MANAGEMENT SYSTEM AND ITS INFLUENCE TO THE MANAGERIAL PERFORMANCE AND THE CONSISTENCY OF THE VACCINE PRODUCT QUALITY IN PT. BIO FARMA (PERSERO) Rika Murhayanti; Marchaban Marchaban; Akhmad Kharis Nugroho
JURNAL MANAJEMEN DAN PELAYANAN FARMASI (Journal of Management and Pharmacy Practice) Vol 2, No 1
Publisher : Faculty of Pharmacy, Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/jmpf.52

Abstract

ISO 9001 is an international standard which commonly used for certification related to the quality management system of company or organization eventhough not all of organization that implemented ISO 9001 seems to get the benefit related to higher organizational performance or consistency of products quality. This research aims to evaluate the implementation of ISO 9001 in the quality management system of PT. Bio Farma (Persero), to find out the influence of the implementation of the ISO 9001 quality management system on the managerial performance and on the consistency of vaccine products quality in PT. Bio Farma (Persero). This research was descriptive analysis retrospective research. The data collected are from the observation on the implementation of ISO 9001, the interview with the related parties, and the document review. The documents reviewed are the manual system guide, Standard Operating Procedure, Report of the Key Indicator Performance, and Report of Annual Product Review (APR). The result of the research shows that PT. Bio Farma (Persero) has already implemented the required elements of the ISO 9001 quality management system were Quality management system (100%), 2) Management responsibility (99,2%), 3) Resources management (100%), 4) Product realization (99,2%), 5) Measurement, analysis and improvement (100%). The implementation of the ISO 9001 quality management system improves the managerial performance of the company, whereas the key performance indicator in the last four years was always achieved, even there was improvement in achievement minimum standard. The consistency of the vaccine quality in the last three years was always achieved as observed from DTP-HB vaccine’s quality parameter that shows the process was capable (Process Capability Index (Cpk) ≥ 1), except for pH parameter within the year of 2007 (Cpk = 0,55) and year of 2009 (Cpk = 0,92); and MWGT parameter within the year of 2007 (Cpk = 0,75). Keywords: quality management system, ISO 9001, managerial performance, consistency of products quality
ANALISIS KEPUASAN PENGGUNA SISTEM INFORMASI MANAJEMEN FARMASI DI RSUD DR. MOEWARDI SURAKARTA Novi Hastuti; Akhmad Kharis Nugroho; Lutfan Lazuardi
Majalah Farmaseutik Vol 7, No 2 (2011)
Publisher : Faculty of Pharmacy, Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (1186.574 KB) | DOI: 10.22146/farmaseutik.v7i2.24052

Abstract

Kepuasan pengguna sistem informasi dapat diukur menggunakan beberapa prediktor diantaranya kualitas sistem, kualitas informasi, dan kualitas pelayanan. Kepuasan pengguna yang tinggi nantinya akan memberikan manfaat yang besar bagi mereka. Kuesioner diisi oleh subyek penelitian sebanyak 34 responden kemudian dianalisis deskriptif, korelasi rank kendall, dan analisis jalur. Untuk memperkuat analisis, dilakukan juga wawancara mendalam terhadap beberapa informan. Korelasi terkuat antara variabel kepuasan pengguna dengan variabel manfaat yaitu 63,2% (p < 0,05). Sedangkan Korelasi antara variabel kualitas informasi dengan kepuasan pengguna yaitu 44,9% (p < 0,05). Variabel kepuasan pengguna paling berpengaruh yakni 68,8% (p < 0,05) secara signifikan terhadap manfaat yang diperoleh pengguna. Sementara itu, variabel kepuasan pengguna dipengaruhi secara kuat dan signifikan sebesar 40,2% (p < 0,05%) oleh kualitas informasi. Dengan demikian, kualitas informasi perlu mendapatkan perhatian lebih besar dalam hal perbaikan sistem informasi selanjutnya yang nantinya diharapkan berujung pada kepuasan pengguna hingga memberikan manfaat besar bagi penggunanya.
Co-Authors Achmad Fudholi Achmad Fudholi Achmad Fudholi Achmad Fudholi Achmad Fudholi ACHMAD FUDHOLI Achmad Fudholi Agatha Budi Susiana Lestari Agung Endro Nugroho Agus Siswanto Agus Siswanto Agus Siswanto Agus Siswanto Ahmad Hamim Sadewa Amalia, Dita Annas Binardjo Annas Binarjo Annisa, Viviane Ardian Dewangga Arief Rahman Hakim Artemisia, Rahma Artemisia, Rahma Beti Pudyastuti BUDIPRATIWI WISUDYA NINGSIH Chandra Saputra Citrariana, Shesanthi Defilia Anograh Riani Diyah Fatmasari Eka Indra Setyawan Elisa Issusilaningtyas Endang Lukitaningsih Endang Lukitaningsih Endang Lukitaningsih Endang Lukitaningsih Eny Masruriati Erna Prawita Setyowati ERNA PRAWITA SETYOWATI Erna Prawita Setyowati Fajar Rakhmatullah Fransiska Lisa Anindya Putri Gultom, Junifrius Harsanti, Dian Dwi Harsanti, Dian Dwi Ika Dewi Ana Ika Puspitasari Isdwiani, Renita Isdwiani, Renita Iwan Dwi Prahasto Iwan Dwi Prahasto Joanne Theophilia Winata Komang Dian Aditya Putra Lina Widyastuti Lucia Hendriati Lukman Hakim Lukman Hakim Lukman Hakim Lutfan Lazuardi Manongga, John Stevie Marchaban Marchaban Marchaban Marchaban, Marchaban Marlyn Dian Laksitorini Marlyn Dian Laksitorini, Marlyn Dian Martien, Ronny Muhammad Novrizal Abdi Sahid Murhayanti, Rika Mustofa Mustofa Nanda Dwi Akbar Nindya - Kusumorini Novi Hastuti NURI ARI EFIANA Nuri Ari Efiana Nuryanti Nuryanti Nuryanti Nuryanti Oktavia Eka Puspita, Oktavia Eka Oktavia Indrati, Oktavia Pawestri, Sekar Ayu Pinandi Sri Pudyani Purwantiningsih Purwantiningsih Purwantiningsih Puspa Dwi Pratiwi Respati, Anindita Kresna Respati, Anindita Kresna Rika Murhayanti Rima Yulia Senja, Rima Yulia Rohman, Abdul Ronny - Martien Ronny Martien Ronny Martien RONNY MARTIEN Ropiqa, Meri Rosyida, Niswati Fathmah Sekar Ayu Pawestri Sekar Ayu Pawestri Sinurat, Ellya Sisca Devi Sisca Devi Siti Fatmawati Fatimah, Siti Fatmawati Sudibyo Martono Sudibyo Martono Sudibyo Martono SUDIBYO MARTONO Sudibyo Martono Sudibyo Martono Sunarto Ang Supraptiyah, Cicilia Supraptiyah, Cicilia Suwaldi . SUWALDI SUWALDI Suwarto, Tiekha Kencanasari Suwarto, Tiekha Kencanasari Suwijiyo - Pramono Teguh Ariyanto Teuku Nanda Saifullah, Teuku Nanda W. Widjijono Yahya Febrianto Yosi Bayu Murti Yosi Bayu Murti