Pharmacel® 101

結晶セルロース
高いバッチ間均一性
湿式および乾式造粒設計のための強力なバインダー

Oral Solid Dose

製品情報

Pharmacel® 101 結晶セルロース (MCC) は、湿式造粒および乾式造粒製剤の主要成分として特別に開発されたものです。DFEファーマはPharmacel® 101を2つの高品質な製造拠点から提供しています。

一貫性

Pharmacel®は、機能特性において高いバッチ間の一貫性を有し、製造時および処方開発時のリスクを低く抑えることができます。

Pharmacel 101 Consistency Graph 1 (1) (1)

Pharmacel 101 Consistency Graph 2 (1) (1)

Pharmacel®と乳糖製剤

DFEファーマは、医薬品製剤の開発において、乳糖と結晶セルロースの両方を提供する唯一のグローバルな添加剤メーカーです。DFEファーマが提供する乳糖グレードとPharmacel®を組み合わせることで、脆性と可塑性の添加剤挙動を完璧に組み合わせ、製剤にさらなるメリットを提供します。

湿式造粒

Pharmacel ®101結晶セルロース（MCC）は、特に湿式造粒製剤の主要成分として開発されました。Pharmacel ®101を使用することにより、造粒液の均一な分散が可能となり、造粒・乾燥工程が均一になります。Pharmacel ®101を用いた湿式造粒は、信頼性が高く、再現性の高い堅牢なプロセスです。Pharmacel ®101を使用した錠剤は、優れた打錠性と崩壊性を示します。

乾式造粒

Pharmacel® 101 結晶セルロース（MCC）は、乾式造粒製剤に使用する添加剤としても最適です。ローラー圧縮時にリボンが圧縮ロールに付着することがなく、乾式造粒は高用量の製剤に使用することができます。乾式造粒の場合、Pharmacel® 101は生産上の重要なシナジーをもたらします。SuperTab® 21AN無水乳糖のような砕けやすい添加剤と併用することで、高い錠剤強度と再圧縮に対する耐性という理想的な組み合わせとなり、非常に堅牢な乾式造粒製剤を実現します。

包装形態

- 25kg PEライナー付き多層紙袋

- サンプルサイズ：500g

生産拠点

インド　Nagpur 、Cuddalore

製品の種類: 結晶セルロース
添加剤の機能性: 充填剤・バインダー, 希釈剤, 結合剤, 崩壊剤
推奨プロセス: 直打法, 湿式造粒, 押出し球形化, 乾式造粒
剤形: 錠剤, カプセル剤（経口固形剤）, 口腔内崩壊錠

代表的な製品データ

粒度分布(μm)

X10: 25
X50: 60
X90: 120

嵩密度(g/L)

嵩密度(g/L): 280

ハウスナー比 (-)

ハウスナー比 (-): 1.57

LOD (% w/w)

LOD (% w/w): 3.8

ドキュメンテーション

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Oral Solid Dose Brochure 表示
Contaminants Statement Pharmacel
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Ingredient declaration lactose
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Ingredient declaration Pharmacel
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Nutritional information Pharmacel
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DFE Pharma Leaflet Pharmacel 101 表示
Product Specification Pharmacel 101
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Process Flow Sheet Pharmacel 101
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cGMP Statement
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BSE Statement Lactose & Inhalation
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Irradiation free
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Contaminants and residues lactose
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Non dangerous substance
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BSE Statement Pharmacel®
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Residual solvent Pharmacel
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Shelf life statement Pharmacel
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Re-compaction properties of lactose and mcc 表示
Roller compaction of anhydrous lactose and mcc 表示
MCC Effect of Increasing Pharmacel Concentration on the Tableting Properties of DC Diluents 表示
Impact of excipient and blend properties on feeding consistency for continuous manufacturing 表示
Choosing the optimal lactose and MCC grade for formulating moisture sensitive drugs 表示

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