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Development Of Analysis Methods Based On Scientific Approach And Risk-Based Approach In The Pharmaceutical Industry: Narrative Review Fahdalis Alifrizqy Massi; Fajrini Adya Rizki Mokoagow; Siti Najma Bakari; Nur Ain Thomas; Faradila Ratu Cindana Mo'o
International Journal of Health Engineering and Technology Vol. 5 No. 2 (2026): Vol 5. No. 2 JULY 2026
Publisher : CV. AFDIFAL MAJU BERKAH

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.55227/ijhet.v5i2.881

Abstract

The development of analytical methods and quality systems in the pharmaceutical industry is now shifting from the conventional trial and error approach to a systematic, scientific, and risk-based approach to meet international regulatory demands. This article aims to examine the effectiveness of implementing the concepts of Analytical Quality by Design (AQbD), Quality by Design (QbD), and various risk management instruments in improving product quality and operational efficiency in the pharmaceutical industry. Methods: This study is the result of a literature review of 15 scientific journals discussing analytical method development, process validation, product stability, and operational risk management. The analysis shows that the application of AQbD and QbD through parameters such as Analytical Target Profile (ATP) and Design of Experiments (DoE) can increase the robustness of analytical methods and reduce the risk of failures such as Out of Specification (OOS). The use of risk management tools such as Failure Mode and Effect Analysis (FMEA) has proven effective in identifying cross-contamination risks and distribution process failures. The integration of scientific and risk-based approaches has a significant positive impact in ensuring quality consistency, accelerating time-to-market, and supporting compliance with ICH guidelines (Q8, Q9, Q10, Q14).
Formulation and Physical Evaluation of Lavender (Lavandula angustifolia) Essential Oil Aromatherapy Candles Tri Sucianita T. Tama; Nurain Thomas; Ariani H. Hutuba; Mohamad Adam Mustapa
Jurnal Farmasi Teknologi Sediaan dan Kosmetika Vol. 3 No. 2 (2026): Volume 3 Nomor 2 Tahun 2026
Publisher : Jurnal Literasi Mandiri

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.70075/jftsk.v3i2.147

Abstract

Lavender flowers are widely used in aromatherapy because their principal constituents, linalyl acetate and linalool, are associated with relaxing effects. Aromatherapy preparations contain volatile aromatic substances intended to promote calmness and relaxation. This study aimed to formulate and physically evaluate aromatherapy candles containing lavender (Lavandula angustifolia) essential oil. An experimental laboratory design was employed, with lavender essential oil as the active ingredient and variations in beeswax and stearic acid concentrations. Formula I contained 50% soy wax, 50% beeswax, and 25% stearic acid, whereas Formula II contained 50% soy wax, 60% beeswax, and 30% stearic acid. The formulations were evaluated for organoleptic characteristics, burning performance, melting point, and hedonic acceptance. Both formulations met the specified physical-evaluation criteria, demonstrating that lavender essential oil can be successfully incorporated into aromatherapy candle formulations
Formulation and Antioxidant Activity Test of Emulgel Extract of Guava (Psidium Guajava Linn.) Using DPPH (2,2-Diphenyl-1- Picrylhydrazyl) Methods Nurain Thomas; Mohamad Aprianto Paneo; Teti Sutriyati Tuloli; Angreni Ayuhastuti; Lutfia Nurfadila Arifin
Jurnal Farmasi Teknologi Sediaan dan Kosmetika Vol. 3 No. 1 (2026): Volume 3 Nomor 1 Tahun 2026
Publisher : Jurnal Literasi Mandiri

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.70075/jftsk.v3i1.291

Abstract

Plants that have the potential to contain antioxidants are guava leaves (Psidium guajava Linn.) which contain one of the compounds, flavonoids, which have antioxidant activity that can reduce free radicals. Emulgel has advantages such as thixotropic, easy to spread, easy to clean, does not leave stains, durable and can be a delivery system for hydrophobic and hydrophilic substances. This study aims to formulate guava leaf extract emulgel and determine antioxidant activity using DPPH method. This research began with guava leaf extraction and base optimization with varying concentrations of stearic acid as an emulsifier consisting of F1 8%, F2 10% and F3 12%. The base that meets the requirements of good physical stability is F2. F2 base was made into emulgel preparations with 3 variations of guava leaf extract concentration, namely F2a 1%, F2b 2% and F2b 3%. The three formulas were tested for physical stability including organoleptic test, emulsion type, pH test, spreadability, adhesiveness, viscosity test, and freeze thaw test as well as antioxidant activity test with DPPH method. The results of the physical stability test showed that the preparations F2a, F2b and F2c met the requirements. The IC50 value in each formulation has a different antioxidant activity value. F2a formulation is 123.59 ppm and F2b is 107.08 ppm which is classified as moderate antioxidant activity, while F2c is 61.74 ppm which is classified as strong antioxidant activity. Guava leaf extract emulgel formula, especially the second formula (F2c), has great potential to be considered by the pharmaceutical industry to be developed into antioxidant products because the results of the evaluation that have been carried out meet the requirements in terms of physical evaluation and potential antioxidant strong.
Formulation of 70% Ethanol Extract Cream of Ketapang Leaf (Terminalia catappa L.) and Efficacy Test for Cut Wound in Mice (Mus muscullus) Nurain Thomas; Fika Nuzul Ramadhani; Nur Rasdianah; Mohamad Aprianto Paneo; Kadaria Toana
Journal of Experimental and Clinical Pharmacy (JECP) Vol 6, No 1 (2026): February 2026
Publisher : Poltekkes Kemenkes Gorontalo

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.52365/jecp.v6i1.1458

Abstract

A laceration (vulnus scissum) is characterized by straight, regular wound edges, typically resulting from sharp object trauma. Ketapang leaves (Terminalia catappa L.) contain bioactive compounds, including flavonoids, saponins, tannins, sterols, alkaloids, and terpenoids, which possess anti-inflammatory properties and the potential to accelerate wound recovery. This study aimed to evaluate the effectiveness of an extract cream derived from T. catappa leaves on laceration healing in mice (Mus musculus). The extract was obtained via maceration using 70% ethanol, followed by phytochemical screening. The cream base was optimized to meet pharmaceutical standards, with evaluations encompassing organoleptic properties, pH, dispersibility, adhesion, viscosity, and freeze-thaw stability. Three formulations were developed with varying extract concentrations: F1 (15%), F2 (20%), and F3 (25%). The in vivo efficacy test involved five groups of mice. Results indicated that all three formulations met the criteria for physical stability. In terms of healing duration, the negative control group required 21 days, while the positive control group achieved healing in 10 days. Among the treatment groups, F1 (15%) and F2 (20%) showed healing times of 18 and 16 days, respectively. Notably, F3 (25%) exhibited the highest efficacy with a healing time of 10 days, comparable to the positive control. Statistical analysis using One-Way ANOVA confirmed these findings with a p-value < 0.05.
Studi Farmakovigilance Obat Herbal Di Kelurahan Tangikiki Kecamatan Sipatana Kota Gorontalo Dengan Metode Naranjo Teti Sutriyati Tuloli; nurain Thomas; Dizky Ramadhani Putri Papeo; Wiwit Zuriati Uno; Putri Fauzia Datunsolang
Journal of Community and Clinical Pharmacy Vol. 3 No. 2 (2026): Vol.3, No.2, 2026
Publisher : Jurnal Literasi Mandiri

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.70075/jccp.v3i2.239

Abstract

Obat tradisional sering kali dihubungkan dengan kepercayaan, tradisi, dan nilai-nilai budaya yang sudah turun-temurun dan untuk menyembuhkan penyakit dengan menggunakan ramuan-ramuan dengan bahan dasar dari tumbuh-tumbuhan dan segala sesuatu yang berada di alam. Tujuan penelitian ini untuk melihat adanya ADRs terhadap penggunaan obat herbal masyarakat di kelurahan tanggikiki kecamatan sipatana kota gorontalo dengan metode naranjo. Metode penelitian deskriptif dengan desain penelitian cross sectional dengan pengambilan sampel purposive sampling dengan kriteria inklusi dan eksklusi. Analisis data menggunakan Naranjo. Hasil Penelitian dari data karakteristik usia mayoritas umur 31-50 tahun 37 (38,1%), jenis kelamin mayoritas perempuan 64 (66%), status pendidikan mayoritas SMU/SMK 49 (50,5%), status pekerjaan mayoritas Ibu Rumah Tangga 44 (45,4%), Masyarakat mayoritas menggunakan obat herbal < 1 tahun 61 (62,9%), sumber informasi obat herbal dari keluarga 62 (63,9%), mayoritas masyarakat meracik sendiri obat herbal 51 (52,6%), mayoritas obat herbal direbus sebanyak 47 (48,5%) dan variasi penggunaan obat herbal 1 kali sehari sebanyak 48 (49,5%). Dari analisis kausalitas menggunakan algoritma Naranjo diketahui bahwa pasien yang menggunakan obat herbal pada kejadian ADRs sebanyak 6 subyek dengan kategori probable sebanyak 2 orang, kategori definite sebanyak 3 orang, dan kategori possible sebanyak 1 orang.
Studi Farmacovigilance Obat Herbal di Kelurahan Pilolodaa Kecamatan Kota Barat Kota Gorontalo Dengan Metode Naranjo Teti Sutriyati Tuloli; Madania Madania; Nurain Thomas; Faradila Ratu Cindana Moo; Najmiyah S. Tuti; mohamad reski manno
Journal of Community and Clinical Pharmacy Vol. 3 No. 2 (2026): Vol.3, No.2, 2026
Publisher : Jurnal Literasi Mandiri

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.70075/jccp.v3i2.242

Abstract

Farmakovigilans obat herbal dengan metode Naranjo merupakan kegiatan pengumpulan, pendeteksian, penilaian, pemahaman dan pencegahan dalam efek samping atau masalah terkait dengan penggunaan obat herbal di menggunakan algoritma Naranjo. Penelitian ini bertujuan untuk menentukan hubungan antara karakteristik pengguna obat herbal dan profil penggunaan obat herbal dengan kejadian Adverse Drug Reactions (ADRs) di Kelurahan Pilolodaa Kecamatan Kota Barat Kota Gorontalo. Penelitian ini dilakukan secara prospektif menggunakan instrument berupa lembar kuesioner pada 97 responden di Kelurahan Pilolodaa. Data hasil penelitian dianalisis secara univariat dan bivariat dengan menggunakan SPSS (Statistical Package For Social Sciences). Hasil penelitian menunjukan bahwa terdapat hubungan antara karakteristik pengguna obat herbal berdasarkan jenis kelamin dengan profil penggunaan obat herbal meliputi sumber informasi dan aturan penggunaan obat herbal. Terdapat juga hubungan antara usia dengan profil penggunaan obat herbal meliputi lama penggunaan, jenis penyakit, efek samping, sumber informasi, tempat memperoleh dan bentuk sediaan. Selain itu terdapat juga hubungan antara Pendidikan dengan jenis penyakit yang menggunakan obat herbal untuk terapinya dan terdapat pula hubungan antara pekerjaan dengan lama penggunaan obat herbal dan aturan penggunaan obat herbal sedangkan antara karakteristik pengguna obat herbal dan profil penggunaan obat herbal dengan kejadian Adverse Drug Reactions (ADRs) di Kelurahan Pilolodaa tidak terdapat hubungan.
Analisis Sistem Penyimpanan Obat Emergensi Di Instalasi Farmasi Dinas Kesehatan Kabupaten Gorontalo: Analysis of the Emergency Medication Storage System at the Pharmacy Unit of the Gorontalo Regency Health Office Nazwa Nurahma T Hanapi; Endah Nurrohwinta Djuwarno; Ariani H. Hutuba; Nur Ain Thomas; Karunita Ika Astuti; Nikma Abaidata
Jurnal Kolaboratif Sains (Special Issue) Jurnal Kolaboratif Sains (JKS) - July 2026
Publisher : Universitas Muhammadiyah Palu

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56338/jks.v9i7.11638

Abstract

Penyimpanan obat emergensi merupakan aspek krusial dalam pelayanan kefarmasian karena berpengaruh langsung terhadap kecepatan penanganan pasien dalam kondisi kegawatdaruratan. Penelitian ini bertujuan untuk menganalisis kesesuaian sistem penyimpanan obat emergensi di Instalasi Farmasi Dinas Kesehatan Kabupaten Gorontalo berdasarkan standar Cara Distribusi Obat yang Baik (CDOB), serta mengidentifikasi faktor-faktor yang mempengaruhinya. Jenis penelitian yang digunakan adalah deskriptif dengan pendekatan observasional. Pengumpulan data dilakukan melalui observasi langsung menggunakan lembar checklist berbasis CDOB, wawancara semi terstruktur dengan Apoteker Penanggung Jawab dan petugas gudang, serta dokumentasi. Hasil penelitian menunjukkan bahwa sebagian besar aspek penyimpanan obat emergensi telah sesuai dengan standar CDOB dengan kategori sangat baik, meliputi kondisi ruangan penyimpanan (100%), suhu dan kelembapan (100%), sistem penyimpanan (100%), segregasi (100%), serta label dan identitas obat (100%). Aspek operasional penyimpanan memperoleh persentase kesesuaian sebesar 86%, sedangkan aspek pengendalian obat hanya mencapai 50% karena masih ditemukannya obat rusak dan kedaluwarsa. Faktor-faktor yang mempengaruhi sistem penyimpanan meliputi keterbatasan jumlah sumber daya manusia, belum meratanya pelatihan CDOB, kapasitas ruang penyimpanan yang terbatas pada kondisi tertentu, serta human error dalam pencatatan stok. Penerapan SOP dan sistem FEFO/FIFO telah berjalan dengan baik. Penelitian ini menyimpulkan bahwa sistem penyimpanan obat emergensi di instalasi tersebut secara umum telah memenuhi standar CDOB, namun aspek pengendalian obat masih memerlukan peningkatan pengawasan terhadap obat rusak dan kedaluwarsa. ABSTRACT Emergency medication storage is a critical aspect of pharmaceutical services, as it directly affects the speed of patient care in emergency situations. This study aims to analyze the suitability of the emergency medication storage system at the Pharmacy Unit of the Gorontalo Regency Health Office based on the Good Drug Distribution Practice (GDDP/CDOB) standards, and to identify the factors influencing it. This study used a descriptive research design with an observational approach. Data were collected through direct observation using a CDOB-based checklist, semi-structured interviews with the responsible pharmacist and warehouse staff, and documentation. The results showed that most aspects of emergency medication storage were in compliance with CDOB standards and classified as very good, including storage room conditions (100%), temperature and humidity control (100%), storage system (100%), segregation (100%), and drug labeling (100%). The operational storage aspect reached 86% compliance, while drug control only achieved 50% due to the presence of damaged and expired medications. Factors influencing the storage system included limited staffing, uneven CDOB training among personnel, limited storage capacity under certain conditions, and human error in stock recording. The implementation of SOPs and the FEFO/FIFO system was found to be well-established. This study concludes that the emergency medication storage system at the pharmacy unit generally meets CDOB standards; however, the drug control aspect still requires improved monitoring of damaged and expired medications.
Penyimpanan Obat dan Alkes di Box/Troli Emergensi di Rumah Sakit Stella Maris Makassar: Storage of Medications and Medical Supplies in Emergency Boxes/Carts at Stella Maris Hospital Makassar Aisyah Agustina Mokoginta; Madania; Mohamad Aprianto Paneo; Teti Tuloli; Nur Ain Thomas; Alfa B Handayani
Jurnal Kolaboratif Sains (Special Issue) - Jurnal Kolaboratif Sains (JKS) - Agustus 2026
Publisher : Universitas Muhammadiyah Palu

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56338/jks.v9i8.11816

Abstract

Penyimpanan obat dan alat kesehatan pada box/troli emergensi merupakan aspek penting dalam pelayanan kegawatdaruratan di rumah sakit karena berperan dalam menjamin ketersediaan, keamanan, mutu, serta kemudahan akses terhadap obat dan alat kesehatan yang dibutuhkan dalam kondisi darurat. Penyimpanan yang tidak sesuai standar dapat menyebabkan keterlambatan penanganan pasien, kesalahan penggunaan obat, serta meningkatnya risiko keselamatan pasien. Penelitian ini bertujuan untuk mengetahui sistem penyimpanan obat dan alat kesehatan pada box/troli emergensi di Rumah Sakit Stella Maris Makassar. Penelitian menggunakan metode deskriptif dengan pendekatan observasional. Pengumpulan data dilakukan melalui observasi langsung menggunakan lembar checklist yang disusun berdasarkan Standar Operasional Prosedur (SOP) penyimpanan obat dan alat kesehatan pada box/troli emergensi di Rumah Sakit Stella Maris Makassar. Aspek yang diamati meliputi penyimpanan obat, penyimpanan alat kesehatan, dan pengelolaan troli emergensi. Data dianalisis secara deskriptif dan disajikan dalam bentuk persentase tingkat kesesuaian. Hasil penelitian menunjukkan bahwa penyimpanan obat dan alat kesehatan pada box/troli emergensi secara umum telah memenuhi kategori baik, meskipun masih ditemukan beberapa ketidaksesuaian pada aspek pengelolaan troli emergensi yang memerlukan perbaikan dan pengawasan lebih lanjut. ABSTRACT The storage of medications and medical devices in emergency boxes/carts is an essential aspect of emergency healthcare services in hospitals, as it plays a crucial role in ensuring the availability, safety, quality, and accessibility of medications and medical devices required during emergency situations. Storage practices that do not comply with established standards may lead to delays in patient management, medication errors, and an increased risk to patient safety. This study aimed to evaluate the storage system for medications and medical devices in emergency boxes/carts at Stella Maris Hospital Makassar. A descriptive study with an observational approach was employed. Data were collected through direct observation using a checklist developed based on the Standard Operating Procedures (SOPs) for the storage of medications and medical devices in emergency boxes/carts at Stella Maris Hospital Makassar. The observed aspects included medication storage, medical device storage, and emergency cart management. The data were analyzed descriptively and presented as percentages of compliance. The results showed that, overall, the storage of medications and medical devices in emergency boxes/carts met the criteria for good practice. However, several non-conformities were identified in the management of emergency carts, indicating the need for further improvement and continuous monitoring.
Preparation and Characterization of Moringa Leaf Extract in Ethosomal Vesicles with Variations in Phosphatidylcholine and Ethanol Concentrations Nur Utami Pobela; Robert Tungadi; Nurain Thomas; Juliyanty Akuba; Multiani S. Latif
Jurnal Farmasi Teknologi Sediaan dan Kosmetika Vol. 3 No. 2 (2026): Volume 3 Nomor 2 Tahun 2026
Publisher : Jurnal Literasi Mandiri

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.70075/jftsk.v3i2.24

Abstract

Moringa is a medicinal plant with antioxidant properties, and quercetin is one of the compounds considered to contribute to this activity. Quercetin is a hydrophobic compound classified as Biopharmaceutics Classification System (BCS) Class II, characterized by high permeability and low solubility. To overcome this limitation and improve the bioavailability of the active compound, the active compound can be encapsulated in a nanosized carrier system. Ethosomes are vesicular carrier systems suitable for lipophilic, hydrophilic, and amphiphilic compounds. This study aimed to prepare and characterize ethosomes containing Moringa leaf extract using different concentrations of phosphatidylcholine and ethanol. Three formulations were prepared: F1 containing 1% phosphatidylcholine and 20% ethanol, F2 containing 2% phosphatidylcholine and 30% ethanol, and F3 containing 3% phosphatidylcholine and 40% ethanol. Characterization using a Particle Size Analyzer (PSA) showed particle sizes of 202.3 nm, 185 nm, and 146.3 nm for F1, F2, and F3, respectively, with mean polydispersity index (PDI) values of 0.346, 0.293, and 0.196. The corresponding entrapment efficiencies were 36%, 35%, and 41%, respectively. F3 exhibited the most favorable characteristics, with the smallest particle size and the highest entrapment efficiency.
Co-Authors Abas, Siti Nur Rahmatiya Abto, Nazarudin Adam Mustapa, Mohammad Aisyah Agustina Mokoginta Akuba, Julianti Alfa B Handayani alkatiri, ahmad alkatiri Alpian Panu, Muhamad Anasiru, Rayhan Firman Andi Makkulawu Andi Makkulawu Anggai, Rifka Anggraini Anggun Sasmita Ibrahim Angreni Ayuhastuti Ar’syifa Wijaya, Hudan Ariani H. Hutuba Ariani H. Hutuba Arista Idris, Pinkan Astuti, Karunita Ika Astuti, Zulfa Amalia Bakari, Mohamad Fadly Basri, Rakhmadana Fitraeni Bioto, Yakob Cristian Polamolo Datu, Novanza L.M.N Defita Zubaidi Devie Ariany Daud Dizky Ramadhani Putri Papeo Dr. Apt. Hamsidar Hasan S.Si.,M.Si Dwy Jayanto Palay, Rendy Ekawaty Prasetya Endah Nurrohwinta Djuwarno Fahdalis Alifrizqy Massi Fajrini Adya Rizki Mokoagow Faradila Ratu Cindana Faradila Ratu Cindana Mo'o Fika Nuzul Ramadhani Fujiana Abd Karim Gita Potabuga Grasela Mbae Hamsidar Hamsidar Harwanto, Yelisnawati Hiola, Faramita Hutuba, Ariani Irmayanti Irmayanti, Irmayanti Ishak Isa Julianty Akuba Kadaria Toana Kahar, Oktaviani LATIF, MULTIANI S Latif, Multiani S. Lihawa, Karmila Lisa Efriani Puluhulawa Lutfia Nurfadila Arifin Madania, Madania Mahdalena Sy Pakaya Makkulawu, Andi Malopo, Ekaria Revalya Mamu, Safira Mahadewi Manno, Mohamad Reski Marsela Idrus Mohamad Maryadi Moh. Rivai Nakoe Mohamad Adam Mustapa Mohamad Aprianto Paneo Mohamad Reski Manno Mohi, Mega Agustiwi Moo, Faradila Ratu Cindana Mo’o, Faradila Ratu Cindana Muhammad Taupik Multiani S Latif Mumtazah, Naharil Munafri, Nur Alifia Karina Nabila Novreini Djunaidi Nabila Pricilia Pakaya Najmi Qamariah Tomayahu Najmiyah S. Tuti Najwa Athifah Tsamarah Umar Nakii, Siti Fatmawaty Nazwa Nurahma T Hanapi Nikma Abaidata Nikmasari Pakaya Nur Amaliah Abdullah Nur Oktaviana Nur Rasdianah Nur Utami Pobela Nurkamiden, Sri Devi Maharani Pakaya, Juniarista Jessica Pakaya, Lutfiah Papeo, Dizky Ramadani Putri Pido, Nur Huda Puluhulawa, Lisa Efriani Putri Fauzia Datunsolang Rahmatia Is. Kaluku Raji, Andre Rismayani, Nur Robert Tungadi Robiatun Rambe Sabrina, Putri Febbiyanti Sapiun, Zulfiayu Selvi Marcellia Sidangoli, Adiva Siti Najma Bakari Sitty Ainsyah Habibie Sri Meylan H.A Baruadi Sri Nur&#039;ain E. Ahmad Suleman, Putri Rawe Suleman, Windy Riani Suryadi, A. Mu'thi Andy Suryadi, A. Mu’thi Andy Suryadi, A.Mu'thi Andy Suryadi,, A. Mu'thi Andy Susanti Pakaya Suyadi, A. Mu’thi Andy Tahir, Sry Megawaty Teti Sutriyati Tuloli Teti Tuloli Thamrin, Rahmulia Timo, Nur Kharisma Ekaputri Tomu, Anita Faradiana Pratiwi R. Tri Sucianita T. Tama Wanda Gita Van Gobel Widy Susanti Abdulkadir Widy Susanti Abdulkadir Widy Susanti Abdulkadir Widy Susanti Abdulkadir Widysusanti A.K Wiwit Zuriati Uno Yasin, Sulistya Yayah Rachmatiyah Yuni Sarah Manoppo Zulkifli B Pomalango Zulmai Rani Zuriati Uno, Wiwit