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All Journal International Journal of Health, Engineering and Technology Jurnal Farmasi Teknologi Sediaan dan Kosmetika (JFTSK)
Nur Ain Thomas
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Agriculture, Biological Sciences & Forestry Chemical Engineering, Chemistry & Bioengineering Dentistry Engineering Health Professions Immunology & microbiology Industrial & Manufacturing Engineering Mechanical Engineering Medicine & Pharmacology Nursing Public Health Veterinary

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Formulasi dan Uji Aktivitas Antioksidan Emulgel dari Ekstrak Daun Bidara (Ziziphus mauritiana Lamk.) Nur Ain Thomas; Endah Nurrohwinta Djuwarno; Widy Susanti Abdulkadir; Andi Makkulawu; Defita Zubaidi
Jurnal Farmasi Teknologi Sediaan dan Kosmetika Vol. 1 No. 3 (2024): Vol 1, No. 3, 2024 : Jurnal Farmasi Teknologi Sediaan dan Kosmetika
Publisher : Jurnal Literasi Mandiri

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.70075/jftsk.v1i3.124

Abstract

Daun bidara (Ziziphus mauritiana Lamk.) merupakan tanaman yang memberikan manfaat luas berkat banyaknya senyawa yang terkandung didalamnya. Senyawa tersebut diantaranya adalah antioksidan dengan potensi aktivitas yang kuat. Emulgel adalah sediaan topikal jenis semisolid yang menggabungkan emulsi dan gel. Sediaan ini memiliki sifat penyebarannya yang baik di permukaan kulit, memberikan rasa lembut dan nyaman saat digunakan. Penelitian ini bertujuan untuk memformulasikan emulgel dari ekstrak daun bidara (Ziziphus mauritiana Lamk.) dan untuk mengetahui adanya kandungan akivitas antioksidan emulgel ekstrak daun bidara (Ziziphus mauritiana Lamk.)dengan menggunakan metode DPPH. Penelitian dimulai dengan mengekstraksi daun bidara (Ziziphus mauritiana Lamk.) kemudian mengoptimasi basis dengan variasi konsentrasi setil alkohol sebagai F1 3%, F2 5% dan F3 7%. Konsentrasi yang menghasilkan stabilitas fisik yang baik adalah F1 3%. Basis dengan konsentrasi 3% setil alkohol diformulasikan menjadi emulgel dengan variasi ekstrak daun bidara (Ziziphus mauritiana Lamk.) F1a 10%, F1b 15% dan F1c 20%. Masing-masing diuji stabilitas fisik seperti uji organoleptik, pH, daya sebar, daya lekat, viskositas dan uji freez thaw serta pengujian akivitas antioksidan dengan metode DPPH menggunakan spektrofotometer UV-Vis. Hasil yang diperoleh menunjukkan ketiga formula memenuhi syarat. Hasil uji statistik one way anova diperoleh p value lebih besar dari 0.05, Hal ini menandakan sediaan memiliki stabilitas fisik yang baik kecuali daya lekat dengan p value <0.05. Menunjukkan adanya perbedaan yang signifikan selama 28 hari penyimpanan. Hasil aktivitas antioksidan menunjukkan dimana IC50 F1a (255,19) dalam kategori sangat lemah, F1b (156,54) kategori lemah dan F1c (109,08) kategori sedang.
The Role Of Stability Testing In Determining The Shelf Life And Storage Conditions Of Pharmaceutical Products: A Narrative Review Najmi Qamariah Tomayahu; Nur Amaliah Abdullah; Nabila Pricilia Pakaya; Sri Meylan H.A Baruadi; 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.v5i2.867

Abstract

Stability testing plays an important role in determining the shelf life and appropriate storage conditions of pharmaceutical products. This narrative review aimed to evaluate the role of Stability testing in maintaining the quality, safety, and effectiveness of pharmaceutical products during storage and distribution. Literature was collected from scientific databases including Google Scholar, PubMed, ScienceDirect, and ResearchGate using keywords related to Stability testing and pharmaceutical storage. The reviewed studies showed that Stability testing, including long-term, accelerated, intermediate, and forced degradation studies, can evaluate physical, chemical, and microbiological changes caused by environmental factors such as temperature, humidity, light, and oxidation. Several studies reported that high temperature and humidity accelerated drug degradation, while appropriate storage conditions maintained product stability within pharmacopeial specifications. Stability data are also essential for determining expiration dates, packaging selection, and storage instructions. Therefore, Stability testing is a crucial scientific approach in the pharmaceutical industry to ensure product quality, regulatory compliance, and patient safety throughout the product shelf life.
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).
Co-Authors Andi Makkulawu Defita Zubaidi Endah Nurrohwinta Djuwarno Fahdalis Alifrizqy Massi Fajrini Adya Rizki Mokoagow Faradila Ratu Cindana Mo'o Nabila Pricilia Pakaya Najmi Qamariah Tomayahu Nur Amaliah Abdullah Siti Najma Bakari Sri Meylan H.A Baruadi Widy Susanti Abdulkadir