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"Distributor farmasi dalam melakukan proses pendistribusian produk obat perlu menjaga mutu obat sesuai ketentuan CPOB. Salah satu cara untuk menjaga mutu obat dengan mempertahankan kondisi penyimpanan (suhu) selama pengiriman dengan menggunakan sistem kemasan yang dapat mempertahankan suhu produk selama masa pengiriman. Tugas khusus ini dilakukan untuk mengoptimasi sistem pengiriman produk di bawah 25°C dengan melakukan pengaturan pada komposisi dan konfigurasi ice gel yang digunakan. Metode yang digunakan yaitu dengan melakukan pengondisian ice gel yang digunakan untuk mencapai suhu target yang ditentukan, kemudian dilakukan pengaturan konfigurasi dan komposisi ice gel yang digunakan di dalam insulated container yang berisi produk sesuai dengan komposisi dan konfigurasi yang diinginkan dan dilanjutkan dengan melakukan monitoring dan pengukuran suhu produk di dalam insulated container. Hasil dari pengondisian dan pengukuran ice gel didapatkan kesimpulan bahwa suhu akhir hasil pengondisian yang dilakukan tidak memenuhi persyaratan suhu karena berada diluar batas 8 - 15°C. Pengaturan komposisi dan konfigurasi dilakukan dengan memposisikan ice gel di samping produk obat dengan diberikan pembatas agar produk tidak bersentuhan langsung dengan ice gel yang digunakan. Hasil dari monitoring suhu produk selama 4 hari masa pengiriman diketahui bahwa konfigurasi dan komposisi kontainer 3 ice gel beku 3 ice gel dingin memberikan ketahanan yang lebih baik selama 51,67 jam atau selama 2,15 hari tanpa adanya penyimpangan suhu, dibandingkan dengan kontainer dengan konfigurasi dan komposisi ice gel 6 beku yang memberikan ketahanan selama 66,33 jam atau 2,76 hari dengan adanya penyimpangan penurunan suhu di bawah 8°C hingga suhu 3,70°C selama 23,17 jam.

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Pharmaceutical distributors in carrying out the process of distributing drugs, need to maintain the quality of drugs according to CPOB. One way to maintain drug quality is to preserve storage conditions (temperature) during shipping by using a secure packaging system. This task was carried out to optimize the product delivery system below 25°C by adjusting the composition and configuration of the ice gel used. The method used is by conditioning the ice gel to reach the specified target temperature, then setting the configuration and composition of the ice gel used in the insulated container, followed by monitoring and measuring the temperature product in an insulated container. The results of the conditioning ice gel concluded that the final temperature results did not meet the temperature requirements because it was outside the range of 8 - 15°C. The composition and configuration settings are made by positioning the ice gel next to the drug product with a barrier so that the product does not come into direct contact with the ice gel used. The results of monitoring product temperature during the 4-day delivery period show that the configuration and composition of the container 3 frozen and 3 cool ice gel provides better shelf life for 51.67 hours or 2.15 days without any temperature deviation, compared to the container with the composition of 6 frozen ice gel which provides durability for 66.33 hours or 2.76 days in the presence of deviation from lowering the temperature below 8°C to 3.70°C for 23.17 hours."

"Machine generated contents note : 1.Introduction2.Types of enteral feeding tubes3.Flushing enteral feeding tubes4.Restoring and maintaining patency of enteral feeding tubes5.Drug therapy review6.Choice of medication formulation7.The legal and professional consequences of administering drugs via enteral feeding tubes8.Health and safety and clinical risk management9.Syringes and ports10.Defining interactionsIndividual drug monographsAbacavirAcamprosate calciumAcarboseAcebutolol"

"Current pharmaceutical and clinical approaches to the treatment of disease suffer from the inherent limitations in the specialization of drugs introduced to physiological systems. The interface of clinical and material sciences has allowed for a broad spectrum of creative approaches with the potential to alleviate these shortcomings. However, the synergy of these disciplines also presents problems in which nascent technology lacks the necessary evaluation within its intended clinical environment. Given the growing potential for materials science to address a number of unanswered therapeutic needs, it remains even more pressing to validate emerging drug delivery technologies in actual clinical environments. This book addresses the core fundamentals of drug delivery using material science and engineering principles, and then applies this knowledge using prominent examples from both the scientific literature and clinical practice"

"Compatibility of pharmaceutical products and contact materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results.Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe :- Pertinent regulations and practical ways to meet guidelines- Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development- Materials characterization and the materials screening process- Component and/or system qualification (illustrated by several case studies)- Performing validation/migration studies and interpreting and reporting the results- Creating a product registration dossier and putting it through regulatory review- Product maintenance (Change Control) from an extractables and leachables perspective- Likely future developments in extractables and leachables assessmentAdditionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature."