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Abstrak :
Proses pembuatan tablet dilakukan secara massal sehingga individualisasi obat menjadi sulit untuk dilakukan. Individualisasi obat dapat dilakukan dengan 3D printer karena dapat menyesuaikan bentuk sediaan dan dosis obat sesuai kebutuhan pasien. Teknik perendaman pelarut merupakan salah satu metode memasukkan zat aktif ke dalam filamen dengan cara difusi pasif. Penelitian ini bertujuan untuk membuat tablet 3D printing dari filamen polimer polivinil alkohol, asam polilaktat, dan polikaprolakton yang mengandung propranolol hidroklorida dengan 3D printer. Ketiga filamen ini dipilih karena terbatasnya ketersediaan filamen di pasaran yang aman untuk dikonsumsi manusia. Filamen polivinil alkohol, asam polilaktat, dan polikaprolakton direndam dalam larutan propranolol hidroklorida dalam tiga konsentrasi selama 45 menit dan kemudian dikeringkan dalam oven selama 6 jam. Filamen tersebut kemudian dicetak menjadi tablet, dilakukan uji disolusi selama 10 jam, dan dianalisis dengan spektrofotometri UV-Vis. Hasil uji disolusi menunjukkan jumlah kumulatif terdisolusi tablet propranolol hidroklorida dari filamen polimer polivinil alkohol lebih tinggi dibandingkan dengan tablet dari asam polilaktat dan polikaprolakton. Kandungan propranolol HCl yang tertinggi pada tablet dimiliki oleh formula PVA C. Meski demikian, pelepasan obatnya membutuhkan waktu 10 jam, sehingga diperlukan penelitian lanjutan terkait filamen polimer yang ideal untuk pembuatan tablet 3D printing dengan metode perendaman pelarut. ......The making process of tablet drug is done in massive scale; thus, individualization of drug therapy is impossible. Individualization of drug therapy can be achieved by using 3D printer because it can suit the dosage form based on the patient’s needs. Solvent immersion is a method to load the drug to the filament through passive diffusion. This study aims to make 3D printed propranolol hydrochloride tablet using polyvinyl alcohol, polylactic acid, and polycaprolactone polymer filament. These three filaments were chosen because of the limited availability of filaments in the market that are safe for human consumption. Polyvinyl alcohol, polylactic acid, and polycaprolactone filament were immersed in three different concentrations of propranolol hydrochloride for 45 minutes and being dried in the oven for 6 hours. Those filaments were used to make 3D printed tablets, went through dissolution test for 10 hours, and the results were analyzed using UV-Vis spectrophotometry. Tablets made of polyvinyl alcohol filament tended to have higher cumulative drug release compared to the tablets made of polylactic acid and polycaprolactone. The tablet that was made by PVA C has the highest propranolol HCl content. However, the time needed for it to dissolute requires 10 hours. Therefore, further research is needed regarding the ideal polymer filament for the manufacture of 3D printed tablets by the solvent immersion method.

Abstrak :
Pengkajian mutu produk obat merupakan salah satu aspek dari Cara Pembuatan Obat yang Baik (BPOM RI, 2018). Pada laporan ini, penulis melakukan pengolahan data terkait hasil kajian yang dilakukan selama proses produksi tablet X dan pengolahan data yang dipaparkan terfokus pada salah satu aspek parameter kritis yaitu, bobot minimum obat 100 tablet. Kajian diawali dengan melakukan input follow up action dari laporan Product Quality Review (PQR) tahun fiskal sebelumnya, input ringkasan bets yang diproduksi dan data yang dibutuhkan untuk penyusunan laporan PQR (hasil uji in process control, parameter kritis, hasil perhitungan rekonsiliasi, dan hasil pengujian Quality Control), input dokumen penunjang berupa penilaian risiko, mengkaji data pemastian mutu, input laporan validasi dan kualifikasi, daftar pemasok, pengendalian perubahan, laporan hasil uji stabilitas, laporan hasil uji sampel pertinggal, investigasi komplain pemasok, dan lain-lain. Pengolahan data dalam bentuk trend dilakukan untuk melihat proses yang dilakukan. Saat melakukan penarikan kesimpulan, metode yang digunakan adalah control chart dan nilai kapabilitas (CpK). Berdasarkan tren, pada proses bobot minimum obat 100 tablet, seluruh titik masuk dalam chart control atau tidak ada satu titik yang melewati Upper Control Limit atau Lower Control Limit. Berdasarkan nilai kapabilitas, proses yang dilakukan stabil dan dalam keadaan kontrol statistik karena nilai Cpk lebih dari 1.5, yaitu 5.68. Penggunaan nilai kapabilitas ditambahkan untuk memperkuat penarikan kesimpulan dan mengetahui kestabilan selama proses. ......Assessment of the quality of products is one aspect of Good Manufacturing Practices (BPOM RI, 2018). One aspect of Good Manufacturing Practices is assessing the quality of medicinal products. In this report, the authors perform data processing related to tablet X's production process. The processing of the data presented focuses on one aspect of the critical parameter, namely, the minimum weight of the drug is 100 tablets. The study begins by inputting follow-up actions from the Product Quality Review (PQR) from the previous fiscal year, inputting a summary of the batch produced and the data needed for the preparation of the PQR report (in process control test results, critical parameters, reconciliation calculation results, and test results of Quality Control), input of supporting documents in the form of risk assessment, reviewing quality assurance data, input of validation and qualification reports, list of the supplier, stability test results reports, test results reports residual samples and investigation of complaints, etc. Data processing in the form of trends is carried out to see the process carried out. The methods to conclude the processes are the control chart and capability value (CpK). Based on the trend, in the process of weighing the minimum drug 100 tablets, all points are within the control chart or there is not one point that passes the Upper Control Limit or Lower Control Limit. Based on the capability value, the process carried out is stable and in a state of statistical control because the Cpk value is more than 1.5, which is 5.68. The use of the capability value is added to strengthen the conclusion and determine the stability during the process.

Abstrak :
Tablet donepezil hidroklorida merupakan salah satu sediaan farmasi untuk terapi Alzheimer yang cukup sering dialami oleh geriatri. Namun, kesulitan menelan tablet pada pasien geriatri seringkali menjadi kendala terapi yang menyebabkan ketidakpatuhan obat. Oleh karena itu, pada penelitian ini dibuat formulasi tablet cepat hancur (TCH) donepezil hidroklorida yang segera hancur di rongga mulut sehingga lebih mudah ditelan. Tujuan penelitian ini adalah mengembangkan formula TCH donepezil hidroklorida dengan metode molding. Formula TCH donepezil hidroklorida dibuat dengan beberapa konsentrasi sodium starch glycolate (SSG), yaitu 0 % (F1), 2 % (F2), dan 4% (F3) dengan metode molding. TCH donepezil hidroklorida yang dihasilkan dievaluasi yang meliputi pengujian organoleptis, waktu hancur, waktu pembasahan, disolusi, penetapan kadar, dan scanning electron microscopy (SEM). Hasil penelitian menunjukkan bahwa TCH donepezil hidroklorida terbentuk bulat sempurna, berwarna putih, dan memiliki rasa manis, waktu pembasahan sekitar 1,22 - 5,13 menit, nilai perolehan kembali sekitar 94 - 115%, rata-rata jumlah obat terdisolusi sekitar 81,65% - 99,73%, hasil SEM menujukkan tablet yang berongga. Selain itu, TCH donepezil hidroklorida formula 2 dan 3 yang dibuat memenuhi persyaratan, karena memberikan hasil uji waktu hancur 5,13 menit ± 0,88 (F1), 1,26 menit ± 0,74 (F2), dan 1,22 menit ± 0,52 (F3). Dari hasil penelitian ini, disimpulkan bahwa TCH F3 menunjukkan hasil terbaik dalam pengujian. ......Donepezil hydrochloride tablet is one of the pharmaceutical dosage form for Alzheimer's therapy which is quite common in geriatrics. However, difficulty swallowing tablets in geriatric patients is often an obstacle to therapy that causes drug non-adherence. Therefore, in this study a formulation of donepezil hydrochloride fast disintegrating tablets (FDT) was prepared which disintegrates immediately in the oral cavity so that it is easier to swallow. The aim of this study was to develop a donepezil hydrochloride TCH formula using the molding method. The donepezil hydrochloride FDT formula was prepared with several concentrations of sodium starch glycolate (SSG), namely 0% (F1), 2% (F2), and 4% (F3) by molding method. The donepezil hydrochloride FDT produced was evaluated which included organoleptic tests, disintegration time, wetting time, dissolution, assay, and scanning electron microscopy (SEM). The results showed that the donepezil hydrochloride FDT formed was perfectly spherical, white in color, and had a sweet taste, wetting time was around 1.22 - 5.13 minutes, the recovery value was around 94 - 115%, the average amount of drug dissolved was around 81.65% - 99.73%, the SEM results showed the tablet was porous. In addition, donepezil hydrochloride FDT formula 2 and 3 complied with the requirements, because it gave disintegration time test results of 5.13 minutes ± 0.88 (F1), 1.26 minutes ± 0.74 (F2), and 1.22 minutes ± 0.52 (F3). From the results of this study, it was concluded that FDT F3 showed the best results in the test.