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"Penelitian ini bertujuan untuk memperluas pemanfaatan pati sebagai eksipien penyalut enterik dan film transdermal melalui pembuatan PPSFt (pragelatinisasi pati singkong ftalat) dengan cara gelatinisasi dan esterifikasi menggunakan ftalat anhidrida dalam suasana basa dan medium berair. PPSFt yang diperoleh dikarakterisasi derajat subtitusi (DS), gugus fungsi, sifat termal, dan kelarutannya. PPSFt yang dihasilkan memiliki DS 0,0541 dan lebih larut pada medium basa. Tablet inti ketoprofen dibuat dengan metode granulasi basah kemudian disalut dengan larutan 5% penyalut PPSFt (F1), PPSFt-HPMCP 4:1 (F2) and PPSFt­ HPMCP 3:2 (F3) hingga kenaikan bobot tablet sekitar 6%. Tablet salut tersebut menunjukkan penampilan, kekerasan, dan keregasan yang baik. Tablet salut F2 dan F3 tidak hancur selama 1 jam dan tidak melepaskan ketoprofen lebih dari 10% selama dua jam dalam medium asam (pH 1,2). Film transdermal PPSFt menunjukkan sifat mekanis yang baik, termasuk ketahanan pelipatan, elongasi dan kekuatan peregangan. Uji disolusi in vitro menunjukkan pelepasan ketoprofen dari seluruh formula film 71,78 - 107,07 % dalam waktu 4 jam melalui mekanisme difusi terkendali. Uji penetrasi in vitro menunjukkan bahwa penetrasi ketoprofen dari film sebanyak 72,77- 108,04% dalam waktu delapan jam dengan kecepatan penetrasi 0,865 - 2,311 mglcm 2.jam. Dapat disimpulkan bahwa PPSFt merupakan eksipien yang baik untuk digunakan sebagai penyalut tablet enterik dan pembentuk film transdermal.

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This present study was intended to expand utilization of starch as enteric-coating and transdermal film-forming excipient by producing pragelatinized cassava starch phthalate (PCSPh) from gelatinitation and esterification process using phthalic anhydride in base condition of aqueous medium. The obtained PCSPh was characterized, including degree of substitution (DS), functional group, thermal properties and solubility. The produced PCSPh possessed DS of 0,0541 and higher solubility in base medium. Core tablets of ketoprofen were prepared by wet granulation method and then coated with coating solution, containing 5% of PCSPh (F1), PCSPh-HPMCP 4:1 (F2) and PCSPh-HPMCP 3:2 (F3), until the increasing weight of tablets were up to 6%. The coated tablets possessed good appearance, hardness and friability. Tablets F2 and F3 were also remain undisintegrated for 1 hour and retain the dissolution of ketoprofen less than 10% for two hours in acid medium (pH 1,2).

Transdermal film which were produced from PCSPh showed good mechanical properties, including folding endurance, elongation and tensile strenght. The in-vitro drug release study showed that 71,78 - 107,07% of ketoprofen has been released from transdermal film in 4 hours by diffusion-controlled mechanism. In-vitro penetration study showed that 72,77 - 108,04% of ketoprofen able to penetrate through skin membran with the flux of 0,865-2,311 mg/cm2.hour. Therefore, it can be concluded that PCSPh had good characteristics to be applied as excipient for enteric-coated tablet and transdermal film."

"ABSTRAKAnalisis berbasis protein kandungan gelatin dalam kapsul dilakukan dengan metode Sodium Dodecyl Sulphate-Polyacrilamide Gel Electrophoresis (SDS-PAGE), dan diikuti oleh analisis densitometri menggunakan software myImage Analysis v.2.0. Gelatin dari sampel diekstraksi dengan menggunakan aseton, kemudian diukur konsentrasinya secara spektrofotometri menggunakan BCA Assay Kit untuk menghitung konsentrasi untuk elektroforesis. Kondisi optimum untuk elektroforesis adalah gel 8% dengan buffer tris-glisin. Gelatin pembanding babi menunjukkan 12 pita dominan (239, 221, 200, 171, 158, 139, 122, 115, 108, 96, 90,dan 83 kDa), sedangkan pembanding gelatin sapi menunjukkan 4 pita dominan (236, 222, 120, dan 107 kDa). Sampel yang mengandung gelatin babi dan gelatin sapi menunjukkan pola yang sama dengan gelatin pembanding.

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ABSTRACTProtein-based analysis of gelatin in capsules was conducted by Sodium Dodecyl Sulphate-Polyacrilamide Gel Electrophoresis (SDS-PAGE) and followed by densitometry analysis using software myImage Analysis v.2.0. Gelatin from samples was extracted using acetone, then measured with spectrophotometry using BCA assay kit to calculate the concentration for electrophoresis. The optimum condition for electrophoresis gel was run on 8% gel with tris-glycine buffer. The results showed that gelatin reference of porcine has 12 major bands (239, 221, 200, 171, 158, 139, 122, 115, 108, 96, 90, and 83 kDa) while bovine gelatin has 4 major bands (236, 222, 120, and 107 kDa). Sample containing porcine and bovine gelatin gave the similar pattern to gelatin reference."

"Produk farmasi memiliki standar kualitas mutu tertentu yang harus dipenuhi sebelum dapat diedarkan secara luas, salah satunya yaitu jaminan kehalalan produk sebagaimana yang tertera di dalam UU Nomor 33 Tahun 2014. Namun, salah satu tantangan utama dalam menjamin kehalalan produk farmasi adalah deteksi bahan baku yang berasal dari sumber yang diharamkan, seperti babi (porcine), anjing (canine), dan tikus (murine). Penelitian ini berfokus pada aplikasi serta evaluasi metode quantitative polymerase chain reaction (qPCR) yang sudah dikembangkan untuk mengidentifikasi gen porcine, canine, dan murine yang dilakukan pada berbagai sampel sediaan farmasi, suplemen, dan kosmetik meliputi krim, serum pencerah yang mengandung ekstrak plasenta babi, dan puyer herbal, dan sejumlah sediaan farmasi lainnya. Konfirmasi stok DNA kontrol positif dengan set primer GAPDH menunjukkan bahwa amplikon porcine, canine, dan murine memiliki panjang berturut-turut 72 bp, 90 bp, dan 101 bp yang mengindikasikan bahwa stok DNA kontrol positif dapat digunakan untuk pengujian selanjutnya. Metode multiplex yang sudah dikembangkan memiliki repeatability yang dapat diterima melalui nilai koefisien variasi (CV) Cq yang didapatkan untuk masing-masing kontrol positif porcine, canine dan murine sebesar 0,61; 0,74; 0,66%. Hasil analisis multiplex terhadap DNA template campuran (mix) dilakukan dengan menilai pergeseran nilai Tm untuk masing-masing gen melalui nilai CV yang didapatkan. Adapun nilai CV intra assay yang didapatkan untuk peak murine, porcine, dan canine berturut-turut yaitu 0,0093%; 0,12%; 0,03%. Hasil ekstraksi dengan menggunakan kit Easyfast Extraction Kit for Pharmaceuticals I belum berhasil mengilangkan inhibitor PCR.

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Pharmaceutical products must meet certain quality standards before being widely distributed such as ensuring the halal status of the products as mandated by Law No. 33 of 2014. However, a major challenge in guaranteeing the halal status of pharmaceutical products lies in detecting raw materials derived from sharia-prohibited sources, such as porcine (pig), canine (dog), and murine (rat). This study focuses on the application and evaluation of the quantitative polymerase chain reaction (qPCR) method that has been developed to identify porcine, canine, and murine genes in various pharmaceutical products, supplements, and cosmetics. The results of positive control confirmation using GAPDH primer sets showed that the amplicons for porcine, canine, and murine genes had lengths of 72 bp, 90 bp, and 101 bp, respectively, indicating that the positive control DNA stock could be used for the next runs. The developed multiplex method demonstrated acceptable repeatability, as shown by the coefficient of variation (CV) values of Cq obtained for the porcine, canine, and murine positive controls, which were 0.61%, 0.74%, and 0.66%, respectively. Multiplex analysis results for mixed DNA templates were assessed by evaluating the shift in Tm values for each gene through the obtained CV values. The intra-assay CV values for murine, porcine, and canine peaks were 0.0093%, 0.12%, and 0.03%, respectively. However, the extraction using the Easyfast Extraction Kit for Pharmaceuticals I was unsuccessful in removing PCR inhibitors."

"Abstract:This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development."

"Abstract:This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development."

"Daun Moringa oleifera Lam. memiliki berbagai manfaat dan efek terapeutik seperti anti-inflamasi, antikanker, antitumor, antimikroba, antioksidan dan antidiabetes. Manajemen Diabetes Mellitus (DM) sangat penting untuk mencegah terjadinya komplikasi. Terapi antidiabetes oral sering menimbulkan efek samping yang cukup serius. Pemberian daun kelor pada hewan menunjukkan efek antidiabetes yang kuat, tetapi efektivitas konsumsi sediaan daun kelor pada manusia menunjukan hasil yang berbeda-beda. Review ini bertujuan untuk meninjau efek konsumsi berbagai bentuk sediaan daun kelor terhadap kadar glukosa darah pada pasien DM dan kemungkinan pengembangan formulasi bentuk sediaan sebagai antidiabetes. Pencarian literatur dilakukan terkait topik selama 10 tahun terakhir, dan beberapa artikel lebih dari 10 tahun yang dapat mendukung teorinya. Hasil review menunjukkan bahwa senyawa bioaktif metabolit sekunder (kuersetin, terpenoid, dan asam klorogenat) dalam daun kelor yang berperan sebagai antidiabetes, perubahan signifikansi pada kadar glukosa darah dari intervensi daun kelor yang paling baik sebesar 28,6% dengan dosis 2 tablet per hari, dan strategi pengembangan formulasi yaitu sediaan kapsul dari ekstrak etanol daun kelor yang dapat meningkatkan efektivitas aktivitas oral antidiabetes.

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Moringa oleifera Lam. leaves has various benefits and therapeutic effects such as anti-inflammatory, anticancer, antitumor, antimicrobial, antioxidants and antidiabetic agents. Diabetes Mellitus (DM) management is very important to prevent complications. Oral antidiabetic therapy often causes quite serious side effects. Giving Moringa leaf to experimental animals showed a strong antidiabetic effect, but effectiveness of consuming Moringa leaf preparations in humans showeds different results. This review aims to review the effects of consuming various Moringa leaf dosage forms on blood glucose levels in humans and the possibility of developing an antidiabetic dosage form. A literature search was carried out related to research on the effectiveness of consumption of various dosage forms of Moringa leaves in DM patients during the last ten years, and several articles over ten years that can support the theory. The result of the review showed that the secondary metabolites (quercetin, terpenoids, and chlorogenic acid) in Moringa leaves that act as antidiabetic, indicate a significant change in blood glucose levels and the best Moringa leaf intervention was 28.6% at a dose of 30 tablets every 15 days for 90 days. Formulation development strategy was capsuled preparation of ethanol extract of Moringa leaves that was increasing the effectiveness of the oral antidiabetic activity."

"Kanker menjadi salah satu penyebab kematian utama pada 10 juta kasus di seluruh dunia pada tahun 2020. Salah satu terapi yang dapat diberikan kepada pasien kanker yaitu menggunakan obat sitostatika. Proses produksi obat sitostatika menurut CPOB memerlukan penanganan khusus seperti produksi di gedung terpisah dari produk non sitostatika, area produksi yang dedikatif, pengaturan sistem tata udara, dan pengaturan kelas kebersihan untuk proses produksi sediaan steril, serta perlindungan terhadap personel dan produk. Penelitian ini bertujuan untuk menelaah proses produksi sediaan sitostatika di PT CKD OTTO Pharmaceuticals, menganalisis kesesuaian proses produksi sediaan sitostatika dengan CPOB dan menganalisis perbedaan proses produksi sediaan sitostatika dibandingkan proses produksi sediaan steril lainnya. Pengambilan data dilakukan dengan observasi, wawancara, dan studi literatur. Hasil penelitian menunjukkan proses produksi sediaan sitostatika di PT CKD OTTO Pharmaceuticals meliputi tahapan  penerimaan bahan awal dan bahan kemas, sampling bahan awal dan bahan kemas, penyiapan sebelum produksi, sterilisasi, pencucian vial dan depyrogenation, penimbangan material, mixing, transfer produk, filling, freeze drying, crimping, external washer, inspeksi visual, pelabelan, pengemasan sekunder, hingga proses agregasi. Seluruh proses produksi sediaan sitostatika di PT CKD OTTO Pharmaceuticals telah sesuai dengan CPOB meliputi aspek bangunan-fasilitas, personalia, kelas kebersihan yang digunakan, pengaturan tekanan udara, sistem terkait produksi, hingga monitoring lingkungan. Terakhir, perbedaan proses produksi sediaan sitostatika dibandingkan proses produksi sediaan steril lainnya terletak pada bangunan, tekanan udara yang digunakan, tahapan penerimaan bahan awal, penimbangan material, mixing, filing, dan external washer.

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Cancer is one of the leading causes of death in 10 million cases worldwide in 2020. One of the therapies that can be given to cancer patients is using cytostatic drugs. The production process of cytostatics according to CPOB requires special handling such as production in a separate building from non-cytostatics products, dedicative production areas, air system settings, and hygiene class settings for the production process of sterile preparations, as well as protection of personnel and products. This study aims to examine the production process of cytostatics preparations at PT CKD OTTO Pharmaceuticals, analyze the suitability of the production process of cytostatics preparations with CPOB and analyze the differences in the production process of cytostatics preparations compared to the production process of other sterile preparations. Data collection was carried out by observation, interview, and literature study. The results showed that the production process of cytostatics preparations at PT CKD OTTO Pharmaceuticals included the stages of receiving initial materials and packaging materials, sampling initial materials and packaging materials, pre-production preparation, sterilization, vial washing and depyrogenation, material weighing, mixing, product transfer, filling, freeze drying, crimping, external washer, visual inspection, labeling, secondary packaging, to the aggregation process. The entire production process of cytostatics preparations at PT CKD OTTO Pharmaceuticals is in accordance with CPOB, including aspects of building-facilities, personnel, hygiene classes used, air pressure settings, production-related systems, and environmental monitoring. Finally, the difference in the production process of cytostatics preparations compared to the production process of other sterile preparations lies in the building, the air pressure used, the stages of receiving initial materials, weighing materials, mixing, filing, and external washers."