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All Journal Bionatura Farmaka Pharmaciana: Jurnal Kefarmasian Media Farmasi : Jurnal Ilmu Farmasi (Journal Of Pharmaceutical Science) Indonesian Journal of Pharmaceutical Science and Technology Jurnal Farmasi Klinik Indonesia MPI (Media Pharmaceutica Indonesiana) IDJP (Indonesian Journal of Pharmaceutics) Farmasains : Jurnal Ilmiah Ilmu Kefarmasian Pharmacology and Clinical Pharmacy Research JSFK (Jurnal Sains Farmasi & Klinis) Jurnal Farmasi Indonesia Jurnal Ilmu Kefarmasian Indonesia Majalah Farmasetika Jurnal Ilmiah Farmako Bahari Indonesia Natural Research Pharmaceutical Journal (INRPJ) Jurnal Farmasi dan Sains Indonesia (JFSI) Journal of Community Development Jurnal Sains dan Teknologi Farmasi Indonesia Obat: Jurnal Riset Ilmu Farmasi dan Kesehatan
Taofik Rusdiana
Departemen Farmasetika Dan Teknologi Farmasi Fakultas Farmasi Universitas Padjadjaran
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Computer Science & IT Health Professions Immunology & microbiology Materials Science & Nanotechnology Medicine & Pharmacology Neuroscience Nursing Public Health Social Sciences

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Therapeutic Drug Monitoring (TDM) Teofilin sebagai Antiasma di Indonesia Elizabeth, Maria; Rusdiana, Taofik
Jurnal Farmasi & Sains Indonesia Vol 6 No 1 (2023)
Publisher : LPPM Sekolah Tinggi Ilmu Farmasi Nusaputera

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.52216/jfsi.vol6no1p33-38

Abstract

Therapeutic Drug Monitoring (TDM) is a clinical pharmacy service aimed at increasing the effectiveness of therapy and improving patient safety. TDM is widely used in the use of drugs with a narrow therapeutic index or can cause toxic effects in small dose changes, such as theophylline. Theophylline is a xanthine class of drugs which is still often used in Indonesia and has a bronchodilatory effect so that it can be used in the treatment of asthma or chronic obstructive pulmonary disease (COPD). This drug has a narrow therapeutic index with a therapeutic dose of between 10-20 mg/L, concentrations above 20 mg/L can cause dangerous side effects such as nausea, vomiting, metabolic acidosis, gastrointestinal bleeding, and even death. Theophylline is one of the drugs that needs to be monitored related to the improvement of symptoms and drug levels in plasma. Therefore, the purpose of writing this article is to look at theophylline monitoring that has been carried out in Indonesia with a literature study approach using inclusion and exclusion criteria. The results obtained are that there are still a few hospitals that carry out therapy drug monitoring related to theophylline levels in the blood.
Monitoring Terapi Warfarin pada Pasien Pelayanan Jantung pada Rumah Sakit di Bandung Putri, Norisca A.; Lestari, Keri; Diantini, Ajeng; Rusdiana, Taofik
Indonesian Journal of Clinical Pharmacy Vol 1, No 3 (2012)
Publisher : Universitas Padjadjaran

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (655.259 KB)

Abstract

Penelitian ini bertujuan untuk mengetahui monitoring terapi warfarin untuk menjamin ketepatan dosis,keamanan terapi, dan mengetahui apakah dosis terapi warfarin yang digunakan telah memenuhi kriteria  penggunaan obat warfarin yang rasional. Derajat antikogulasi setiap pasien diukur dengan parameter waktu protrombin yang dinyatakan dengan International Normalized Ratio (INR). Metode Penelitian meliputi monitoring terapi warfarin terhadap 80 pasien di pelayanan jantung melalui PT-INR, pendataanklinis pasien meliputi, usia, jenis kelamin, berat badan, tinggi badan, jenis penyakit, dosis yang digunakan dan obat lain yang dikonsumsi secara bersamaan. Hasil monitoring menunjukkan rata-rata INR pasien yaitu 1,38± 0,42 hasil ANAVA (α = 0,05) menunjukkan tidak ada pengaruh dosis terhadap INR(p=0,13) tetapi ada pengaruh pada umur (p =0,014), hasil uji beda (α = 0,05) menunjukkan tidak ada perbedaan terhadap rata-rata INR berdasarkan jenis kelamin (p =0,051), umur (p =0,397), dan variasi dosis (p = 0,057). Hasil tersebut menunjukkan bahwa dosis warfarin belum mencapai target terapi INR (2–3).Kata kunci: Warfarin, penyakit trombotik, PT-INR Warfarin Therapy Monitoring of Cardiac Care Patients in Hospital in BandungAbstractThe aims of this study were to identify the rational warfarin monitoring therapy to guarantee the rightdose, therapy security, and whether the dose of warfarin therapy has completed the rational criteria ornot. Degree of antikoagulasi for each patient is measured with protombin time as International Normalized Ratio (INR). The methods consist of warfarin monitoring therapy towards 80 patients at the heart service through the PT-INR constant, medical data, such as age, gender, weight, height, type of the disease, dose usage and another medicine which is used together, and statistical test of the average of INR. The monitoring result shows that patient’s INR average is 1,38 ±0,42, the result of ANAVA (α=0,05)shows that there’s no impact of dose towards INR (p=0,13) but there’s an INR average impact basedon gender (p=0,051), age (p=0,397) and dose variation (p=0,057). The results shown that warfarin dose which used is not bleeding risk.Key words: Warfarin, trombotic disease, PT-INR
PENGARUH KOMPLEKSASI INKLUSI ATORVASTATIN DENGAN β-SIKLODEKSTRIN TERHADAP FORMULASI DAN EVALUASI FAST DISINTEGRATING TABLETS (FDT) ATORVASTATIN Fadil, Dilal Adlin; Rusdiana, Taofik; Muchtaridi, Muchtaridi
Media Farmasi: Jurnal Ilmu Farmasi Vol. 13 No. 2: September 2016
Publisher : Universitas Ahmad Dahlan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.12928/mf.v13i2.7768

Abstract

Atorvastatin merupakan salah satu zat aktif penurun kolesterol darah golongan statin atau inhibitor HMG-CoA reductase. Atorvastatin memiliki karaktersitik biofarmasetik kelarutan dalam air yang buruk tetapi  permeabilitas dalam membran usus yang tinggi (BCS kelas II), sehingga untuk memperbaiki bioavailabilitasnya dapat diupayakan dengan cara memperbaiki tingkat kelarutannya dalam air. Penelitian ini bertujuan untuk mengetahui pengaruh kompleksasi inklusi atorvastatin dengan β-siklodekstrin terhadap kelarutan dan disolusinya serta terhadap proses formulasi sediaan Fast Disintegrating Tablets (FDT). Kompleks inklusi dibuat dengan cara kneading method dengan perbandingan molar atorvastatin dengan β-siklodkestrin; 1:1, 1:2, dan 1:3. Studi ketetapan kesetimbangan kompleks didapat 502,087 M-1. Hasil uji disolusi dalam medium buffer fosfat pH 6,8 menunjukkan peningkatan laju disolusi atorvastatin dalam kompleks inklusi atorvastatin-β-siklodkestrin (KIAS) masing-masing sekitar 5,76% (1:1); 8,89% (1:2); dan 7,73% (1:3). Hasil karakterisasi KIAS dengan metode X-ray difraction (X-RD), spektroskopi inframerah, dan differential scaning calorimetry (DSC) menunjukkan adanya pembentukan kompleks inklusi. Formulasi FDT dibuat dengan menggunakan metode kempa langsung terhadap 6 formula (3 formula menggunakan KIAS dan 3 formula tanpa KIAS), superdisintegrat yang digunakan adalah Kyron T 314 dengan variasi penggunaannya masing-masing sebanyak 2, 4, dan 6% dan variasi kekerasan tablet sebesar 4 dan 6 N. Hasil evaluasi FDT menunjukan bahwa FDT dengan KIAS lebih baik dibandingkan dengan FDT tanpa KIAS. Hasil uji disolusi FDT dalam medium buffer fosfat pH 6,8 diketahui terjadi peningkatan laju disolusi atorvastatin dalam FDT KIAS. Dengan demikian, dapat disimpulkan bahwa kompleksasi inklusi atorvastatin dengan β-siklodkestrin dapat meningkatkan laju disolusi atorvastatin secara signifikan.
Review: Preparation of Flavonoid Nanoparticles using the Nanoprecipitation Method Pratama, Rizky Farhan; Sopyan, Iyan; Rusdiana, Taofik
Indonesian Journal of Pharmaceutics Vol 4, Issue 3, Sep - November, 2022
Publisher : Universitas Padjadjaran (Unpad)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24198/idjp.v4i3.40849

Abstract

Flavonoids are polyphenolic compounds that have 15 carbon chains, 2 benzene rings and a heterocyclic pyran ring. From the literature study, it is known that flavonoids have various pharmacological activities such as anticancer, antimicrobial, antiviral, antiangiogenic, antimalarial, antioxidant, neuroprotective, antitumor, and antiproliferative agents. However, flavonoids have limited oral bioavailability which may be due to their poor solubility, low permeability, and low stability, which impair their effectiveness as therapeutic agents. One of the efforts to increase solubility is nanoparticle technology where the active compound particles are reduced to the nanometer scale, usually up to 100 nm. Nanoprecipitation is a method of preparing nanoparticles by dissolving the active drug substance and polymer into an organic solvent and then adding an anti-solvent such as water. The advantages of this method are the production is relatively fast, inexpensive, does not require a lot of energy, and does not require emulsion precursors. The purpose of this literature review is to examine the technique of making flavonoid nanoparticles using the nanoprecipitation method, the results of their characterization and evaluation. Based on a literature review that has been carried out on 30 journals, there are 20 flavonoid secondary metabolites that have been prepared into nanoparticles using the nanoprecipitation method. Some of the polymers used were effective in achieving satisfactory particle size, polydispersity index (PDI), Zeta potential and Encapsulation Efficiency (EE%). Thus, the nanoprecipitation method can be used to make flavonoid nanoparticles with optimal formulations to improve the physicochemical properties of flavonoids for drug development in the future.
Gap Analysis CPOB 2018 Terhadap Rancangan Revisi CPOB 2024 Aneks 1 Pembuatan Produk Steril Aspek Peralatan, Sarana Penunjang, dan Personalia Gracia Anastasya; Taofik Rusdiana; Ella Fazila
OBAT: Jurnal Riset Ilmu Farmasi dan Kesehatan Vol. 3 No. 2 (2025): March: OBAT: Jurnal Riset Ilmu Farmasi dan Kesehatan
Publisher : Asosiasi Riset Ilmu Kesehatan Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.61132/obat.v3i2.1136

Abstract

The pharmaceutical industry operates under a strict regulatory framework to ensure that the products produced are safe, of high quality, and effective. These regulations are continuously updated to keep up with advancements in science, technological developments, and global demands for higher quality standards. The pharmaceutical industry also faces the challenge of global regulatory harmonization, such as standards set by WHO and PIC/S. These regulations are designed to ensure drug quality from development to distribution. Changes in Good Manufacturing Practices (GMP) regulations are crucial for improving pharmaceutical production quality in Indonesia. This study aims to conduct a gap analysis between the 2018 GMP and the draft 2024 GMP Annex 1, particularly in terms of equipment, supporting facilities, and personnel. The method used is a comparative analysis by comparing the provisions of the 2018 GMP with the draft 2024 GMP. The gap analysis results between the 2018 GMP and the draft 2024 GMP Annex 1 in terms of equipment, supporting facilities, personnel, and sterile product completion indicate significant changes in the adopted standards. The proposed 2024 GMP revision introduces substantial improvements in sterile product manufacturing standards. As part of efforts to enhance global competitiveness, the Indonesian pharmaceutical industry must continue to adapt to dynamic technological and regulatory changes. By implementing various strategies—including substantial investments in modern equipment, adjustments to supporting facilities, and capacity building for personnel—the Indonesian pharmaceutical industry can meet global standards while ensuring the availability of safe, high-quality, and effective sterile products for the public.
Kajian Risiko terkait Kontaminasi dan Ketercampuran di Ruang Penimbangan Industri Farmasi “XYZ” Insyirah, Ariani; Rusdiana, Taofik; Rambia, Ikhsan
Majalah Farmasetika Vol 10, No 6 (2025)
Publisher : Universitas Padjadjaran

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24198/mfarmasetika.v10i6.65646

Abstract

Industri farmasi memiliki peran dan tanggung jawab memastikan obat yang diproduksi aman, berkhasiat, dan bermutu sampai dikonsumsi oleh konsumen. Di Indonesia, terdapat PerBPOM Nomor 7 Tahun 2024 yang mengatur terkait seluruh proses dan ketentuan dalam pembuatan obat sehingga dapat memenuhi kriteria tersebut. Dalam proses pembuatan obat, salah satu hal yang perlu diperhatikan adalah terkait risiko kontaminasi dan ketercampuran saat penimbangan bahan baku. Potensi risiko tersebut dapat dikelola dengan cara melakukan kajian risiko. Salah satu metode pendekatan yang biasa digunakan adalah failure mode effect analysis (FMEA) yang berfokus pada tindakan pencegahan terjadinya kegagalan. Di industri farmasi “XYZ”, penilaian risiko biasa dilakukan dengan cara observasi secara langsung, melakukan wawancara dengan operator, dan berdiskusi dengan bagian tertentu terkait kemungkinan risiko yang dapat terjadi. Terdapat empat hal yang diidentifikasi, yaitu pakaian kerja, peralatan, kondisi ruangan, dan penandaan. Diperoleh total 11 risiko kegagalan dengan rincian lima berisiko rendah (terkait peralatan, kondisi ruangan, dan penandaan) dengan nilai RPN < 30, satu berisiko sedang (terkait penandaan) dengan nilai RPN 30 ≤ RPN ≤ 60, satu berisiko tinggi (terkait pakaian kerja) dengan nilai RPN 75 ≤ RPN ≤ 100, dan empat berisiko sangat tinggi (terkait pakaian kerja dan peralatan) dengan nilai RPN ≥ 150 sehingga menjadi prioritas utama yang perlu diselesaikan. Beberapa hal yang dapat dilakukan untuk mengurangi risiko adalah memberikan pelatihan operator, merevisi SOP secara berkala, memastikan formulir pemantauan diisi oleh operator, serta memastikan peralatan dan pakaian kerja yang digunakan memiliki jumlah dan spesifikasi yang sesuai dengan ketentuan. Hal tersebut sudah mulai diterapkan dan memberikan hasil yang baik. Dengan mengendalikan potensi risiko kontaminasi dan ketercampuran, obat yang dihasilkan oleh industri farmasi diharapkan memenuhi tiga kriteria terkait keamanan, khasiat, dan kualitas.
Co-Authors Abdasah, Marline Aep W Irwan Aep W Irwan, Aep W Afra, Dinda Nur Ajeng Diantini, Ajeng Alfaqeeh, Mohammed Aliya Nur Hasanah Amelia Soyata Ami Tjitraresmi Amira Nur Hasanah ANANG SUBGHAN Anas Subarnas Anis Khorunisa Anis Khorunisa, Anis Anis Y. Chaerunisaa Anis Yohana Chaerunisaa Anis Yohana Chaerunisaa Anis Yohana Chaerunisaa Anis Yohana Chaerunnisa Arna Ningsih1, Endah ARVENDA REZKY PRATAMA Asep Nurrahman Yulianto Azizul Hakim Camellia Panatarani CINDY MELINDA SOFYANI Dani Sujana Dessy Ikasari Desy Nawangsari Desy Nawangsari Dewi Mayasari Dewi Mayasari Dewi, Febrina Aulia Dika P. Destiani Dilal Adlin Fadil Dolih Gozali DOLIH GOZALI Dwi Retno Sari Eka Riza Maula ELI HALIMAH Eli Halimah, Eli Elis Lisnawati Elizabeth, Maria Ella Fazila Fadil, Dilal Adlin Fadil, Dilal Adlin FAJAR SETIAWAN Febrina Aulia Dewi Firman Gustaman Firmansya, Ardianes Fitrileni - Fitrileni -, Fitrileni Fitrileni Fitrileni Gracia Anastasya GUSTIN HIDAYATI Hindun, Siti I Made Joni Ina Widia Insyirah, Ariani Iyan Sofyan, Iyan Iyan Sopyan Jajan Solahudin Jajan Solahudin, Jajan Keri Lestari Khairinisa, Miski A. Lana Labibah Lanny Indah Permatasari, Lanny Indah Linda Apriyanti LINDA APRIYANTI, LINDA Lusi Nurdianti, Lusi Lutfi Sulaiman M. Abdul Aziz Prakoso Mardhiani, Yanni Dhiani Mardhiani, Yanni Dhiani Maria Elizabeth Marline Abdasah Marline Abdassah Marline Abdassah Marline Abdassah Marline Abdassah Marline Abdassah, Marline Mentari Luthfika Dewi Mohamad Aprianto Paneo Mohammad R. Akbar Muchtaridi Muchtaridi Muhammad Habil Abrar Alhamdra Muhammad Lukman Nur Hakim Multiani S Latif Mutakin Mutakin Nagina Gulab Belali Nagina Gulab Belali Nasrul Wathoni NOPI RANTIKA Norisca A. Putriana Norisca A. Putriana Norisca A. Putriana Norisca Aliza Putriana Norisca Aliza Putriana Patihul Husni PATIHUL HUSNI Patihul Husni Pratama, Rizky Farhan Putri, Norisca A. Putri, Norisca A. Rambia, Ikhsan Ratu Kania, Yulien RENATA VANIA Reti Hindritiani Revika - Rachmaniar RIFA NURFAUZIAH Rizki Akbar Rizki Akbar, Rizki SABNABILA KHOERUN NISA Selifiana, Nita Shinta Lestari Shofiyyah Sayyidah Silvia, Nurfianti Siti Hindun Sri A Sumiwi Sri A Sumiwi, Sri A Sri Adi Sumiwi Sriwidodo Sriwidodo Sriwidodo Sriwidodo Sriwidodo Sriwidodo, Sriwidodo Suseno Amin Suseno Amin, Suseno Suwandi, Deden Winda Tina Rostinawati Wirna Grace Tua Sihombing Yedi Herdiana Yoga Windhu Wardhana Yohana Chaerunisaa, Anis Yuli Agung Prasetyo Yulianto, Asep Nurrahman Yulien Ratu Kania YUNIKE KARUNIA PUTRI Yuti Mutiawati Yuti Mutiawati Yuti Mutiawati, Yuti