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オパドライ™ II 完全処方化水系フィルムコーティングシステム
オパドライ II 製品は、医薬品および栄養補助食品用経口固形製剤の水系フィルムコーティングのための完全処方化ドライブレンドシステムから構成され、工程時間の短縮と優れたフィルムの仕上りを提供しています。オパドライII は、速く薬物を放出させるために迅速に崩壊するポリマー、可塑剤、着色剤から構成されており、高生産性でpH非依存性の水溶性完全処方化ドライパウダーフィルムコーティング剤です。
オパドライII は:
- コーティング工程時間の短縮 -- 従来のフィルムコーティング処方に比べて25%の節減
- 生産能力の向上 -- 工程時間の短縮により、コーティング装置の自由度が増加
- 優れた製品外観 -- 接着力の高いポリマーによりコーティング困難な素錠にも鮮明な刻印
- 幅広い処理能力 -- あらゆるタイプのコーティング装置と素錠でも簡単に使用可能
- アプリケーションが容易 -- 混合物は水で簡単に溶液調整でき、30-45分以内に使用可能
- 均一性に優れた水系フィルムコーティングで、滑らかな錠剤仕上がりと優れた光沢 -- 低粘度により、最適な液滴サイズ
- 一製品としての混合物なので、原料の在庫、QC試験、書類の各費用を削減
推奨用途
- 様々な医薬品有効成分(API)を含む幅広い錠剤への使用に最適
- 20%の固形溶液が可能な着色システム
オパドライII がいかにして、優れたコーティングの生産性と性能につながる近道になるか知ってください。
プロダクトアプリケーションデータ
Effect of Coating Process Conditions and Coating Formula Type on the Quantity and Location of Water in Film Coated Tablets
ドキュメントのダウンロード 電子メールで送信Study of process conditions and formula type on tablet moisture gain.
Modern Tablet Film Coatings and Influence on Ease of Swallowing
ドキュメントのダウンロード 電子メールで送信This Application Data Sheet is extracted from a study of esophageal transit times using uncoated and film-coated caplets,oval tablets, plus hard and soft-gelatin capsules. Reprint of poster presented at the American Association of Pharmaceutical Scientists Meeting, 2003.
一般的な情報
Opadry® Cleaning Instructions
ドキュメントのダウンロード 電子メールで送信General directions for clean up after use of most Opadry product formulations.
製品のプロセスパラメーター
Opadry® II Coating Parameters - Clear (PVA-based) Formulations
ドキュメントのダウンロード 電子メールで送信Starting process recommendations for use of Opadry II, clear formulations.
Opadry® II Coating Parameters - Pigmented (PVA-based) Formulations
ドキュメントのダウンロード 電子メールで送信Starting process recommendations for Opadry II pigmented formulations.
調製方法
Opadry® II - Reconstitution
ドキュメントのダウンロード 電子メールで送信Mixing procedure and holding instructions for Opadry II coating formulations.
製品カタログ
Opadry® II - Product Information Brochure
ドキュメントのダウンロード 電子メールで送信Introduction to the Opadry II platform of aqueous PVA and HPMC-based immediate release film coating systems.
ポスター
AAPS 2003 - Modern Tablet Film Coatings and Influence on Ease of Swallowing
ドキュメントのダウンロード 電子メールで送信The objective of this study was to investigate if film coated tablets have shorter mean esophageal transit times and lower incidences of transit delays than those of uncoated tablets, or comparably sized hard or soft gelatin capsules.
AAPS 2005 - Evaluation of a Film Coating that Produces Enhanced Tablet-to-Tablet Film Uniformity
ドキュメントのダウンロード 電子メールで送信In this study, Opadry II (85 series) Clear was shown to have lower coating weight gain standard deviations than a standard clear hypromellose based film coating. Pigmented Opadry II (85 series) achieved similar or better coating color uniformity with a 1/3 savings in processing time.
AAPS 2005 - Investigation into the Flow Properties of Coated and Uncoated Tablets and Its Relevance to Blister Packing Efficiency
ドキュメントのダウンロード 電子メールで送信Study on reducing contamination and improving packaging line efficiency through the application of a fully formulated film coating.
AAPS 2006 - Protection and Processing of a Highly Hygroscopic Herbal Extract by Drug Layering and Film Coating
ドキュメントのダウンロード 電子メールで送信Study of the stability improvements for Echinacea Purpurea beads layered with a moisture PVA and HPMC based barrier film coating.
AAPS 2007 - Reducing Coated Tablet Defects from Laboratory Through Production Scale: Performance of Hypromellose Based and Polyvinyl Alcohol Based Aqueous Film Coating Systems
ドキュメントのダウンロード 電子メールで送信The purpose of this study was to examine the effect of film coating formulations in reducing or preventing coating defects on a soft and friable multivitamin tablet.
AAPS 2008 - Evaluation of Recent Advances in Continuous Film Coating Technology in Reducing or Eliminating Potential Product Losses
ドキュメントのダウンロード 電子メールで送信This study evaluates the performance of Opadry II in a continuous coating process and demonstrates that improvements in continuous coater designs have reduced the need for re-work or discarding of partially coated product.
AAPS 2008 - Scuffing Measurement Methodology and Improved Film Coating Systems
ドキュメントのダウンロード 電子メールで送信This study describes laboratory tests to measure scuffing on film coated tablets and provides process and maintenance recommendations to prevent the occurrence of scuffing.
AAPS 2009 - Determination of Trace Formic Acid and Formaldehyde in Film Coatings Comprising Polyvinyl Alcohol (PVA)
ドキュメントのダウンロード 電子メールで送信This work describes the application of a methodology developed by Amgen to determine the amounts of formic acid and formaldehyde in PVA-based film coatings.
AAPS 2009 - Film Coating Process Considerations for the Application of High Productivity, High Solids Concentration Film Coating Formulations
ドキュメントのダウンロード 電子メールで送信Using a Design of Experiments (DOE) approach, this study examines the effect of solids concentration on color uniformity and coating weight variation (CWV) in a batch coating process.
AAPS 2009 - Influence of Film Coating Process Parameters on the Gloss of Tablets Coated with Pigmented Aqueous Film Coating Formulations
ドキュメントのダウンロード 電子メールで送信The purpose of this study was to examine the effects of coating process parameters and dispersion solids concentration on the gloss of tablets coated with single-step, pigmented aqueous film coating formulations.
AAPS 2009 - Maximizing the Gloss of PVA-Based Film Coating Systems
ドキュメントのダウンロード 電子メールで送信Results of this study reveal gloss level improvements when PVA-based pigmented film coatings are applied at lower solids content levels.
AAPS 2009 - Use of Maximum Fluid Delivery Rate Measurements to Assess the Productivity of Moisture Barrier Film Coatings
ドキュメントのダウンロード 電子メールで送信The aim of this study was to develop a small-scale method predicting film coating productivity of moisutre barrier film coatings. Maximum fluid delivery rates were used to evaluate the productivity and inherent tack of formulations, Opadry II, Opadry amb and a developmental formulation.
AAPS 2010 - Stability of Six Model Drug Products Coated with PVA-based Opadry® II
ドキュメントのダウンロード 電子メールで送信The purpose of this study was to investigate the influence of PVA-based OpadryII systems on stability and release of immediate release formulations containing six model drugs, after storage at accelerated conditions.
AAPS 2011 - Effect of Film Coating on the Stability of ER Metformin Hydrochloride POLYOX™ Matrices
ドキュメントのダウンロード 電子メールで送信Application of PVA-based Opadry II results in enhanced tablet stability and prevented loss of mechanical strength during accelerated storage conditions
AAPS 2013 - Immediate Release Film Coating of an Acetaminophen Extended Release Matrix Tablet Containing a High Concentration of Polyethylene Oxide Water Soluble Resin
ドキュメントのダウンロード 電子メールで送信Investigation of film coating with Opadry II on hydrophilic matrix tablets
AAPS 2020 - Evaluation of Different Opadry® Film Coating Systems on Tablets Containing Amorphous Solid Dispersion of Itraconazole
ドキュメントのダウンロード 電子メールで送信AAPS 2021 - Performance and Stability of an On-Dosage Authentication Technology Using Molecular Tags on the Coated a Model Active ja
ドキュメントのダウンロード 電子メールで送信CRS 2003 - The Influence of Film Coatings on Performance of Hypromellose Matrices
ドキュメントのダウンロード 電子メールで送信Study on the influence of three film coating systems on the performance of hypromellose sustained release matrices, stored under different conditions up to 12 months.
CRS 2006 - Effect of Film Coating and Storage Conditions on the Performance of Metformin HCl 500 mg ER Hypromellose Matrices
ドキュメントのダウンロード 電子メールで送信Influence of three film coating systems on the performance of Metformin HCl (500mg) extended release (ER) Hypromellose matrices.
SAFYBI 2005 - Coating Moisture-Sensitive Products with Opadry® II
ドキュメントのダウンロード 電子メールで送信Influence of inlet temperature and airflow on moisture uptake by tablet cores using a PVA-based film coating system.
ホワイトペーパー/記事
Dare to be Different - Use Color and Shape for Unique Tablet Design
ドキュメントのダウンロード 電子メールで送信This article is from Medicine Maker, March 2015 issue.
Film Coating for Pediatric Oral Solid Dosage Forms
ドキュメントのダウンロード 電子メールで送信Getting the Right Coating for Pediatric Tablet Formulations