JP6480936B2 - クライオミリングによる粉末状医薬組成物の調製 - Google Patents
クライオミリングによる粉末状医薬組成物の調製 Download PDFInfo
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- JP6480936B2 JP6480936B2 JP2016534227A JP2016534227A JP6480936B2 JP 6480936 B2 JP6480936 B2 JP 6480936B2 JP 2016534227 A JP2016534227 A JP 2016534227A JP 2016534227 A JP2016534227 A JP 2016534227A JP 6480936 B2 JP6480936 B2 JP 6480936B2
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Images
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B02—CRUSHING, PULVERISING, OR DISINTEGRATING; PREPARATORY TREATMENT OF GRAIN FOR MILLING
- B02C—CRUSHING, PULVERISING, OR DISINTEGRATING IN GENERAL; MILLING GRAIN
- B02C7/00—Crushing or disintegrating by disc mills
- B02C7/11—Details
- B02C7/17—Cooling or heating of discs
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B7/00—Mixing; Kneading
- B29B7/02—Mixing; Kneading non-continuous, with mechanical mixing or kneading devices, i.e. batch type
- B29B7/06—Mixing; Kneading non-continuous, with mechanical mixing or kneading devices, i.e. batch type with movable mixing or kneading devices
- B29B7/10—Mixing; Kneading non-continuous, with mechanical mixing or kneading devices, i.e. batch type with movable mixing or kneading devices rotary
- B29B7/18—Mixing; Kneading non-continuous, with mechanical mixing or kneading devices, i.e. batch type with movable mixing or kneading devices rotary with more than one shaft
- B29B7/20—Mixing; Kneading non-continuous, with mechanical mixing or kneading devices, i.e. batch type with movable mixing or kneading devices rotary with more than one shaft with intermeshing devices, e.g. screws
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B9/00—Making granules
- B29B9/10—Making granules by moulding the material, i.e. treating it in the molten state
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B9/00—Making granules
- B29B9/12—Making granules characterised by structure or composition
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B9/00—Making granules
- B29B9/16—Auxiliary treatment of granules
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B9/00—Making granules
- B29B9/12—Making granules characterised by structure or composition
- B29B2009/125—Micropellets, microgranules, microparticles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2071/00—Use of polyethers, e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as moulding material
Description
(c)上記医薬添加剤および上記医薬成分の混合物を周囲温度より低い温度で粉砕するステップ、
を含む方法。
(c)上記医薬添加剤および上記医薬成分の混合物を周囲温度より低い温度で粉砕するステップ、
を含む方法に関する。
−前記医薬添加剤、好ましくは第1の医薬添加剤は、ポリマー、より好ましくは線状ポリマーであり、さらに好ましくは水溶性ポリマー、より一層好ましくはポリアルキレングリコール、最も好ましくはポリエチレングリコールであり;および/または
−前記医薬成分、好ましくは第2の医薬添加剤は、酸化防止剤、好ましくはトコフェロール成分、より好ましくはα−トコフェロールである。
(b)医薬添加剤、好ましくは第1の医薬添加剤(ポリアルキレングルコールであり、より好ましくはポリエチレングリコールである)と、医薬成分、好ましくは第2の医薬添加剤、より好ましくはα−トコフェロールとの混合物を、上記混合物の液体溶融物が押出機において凝固でき、粉末の形態で押出機を出ることができる温度プロファイルで、押出機において押出すステップ。
−T1は、医薬添加剤、好ましくは第1の医薬添加剤(これはポリアルキレングリコール、より好ましくはポリエチレングリコールである)、および/または医薬成分、好ましくは第2の医薬添加剤、より好ましくはα−トコフェロール、および/または任意選択的に存在する第3構成成分の融点/溶融域より大きく;および/または
−T2は、医薬添加剤、好ましくは第1の医薬添加剤(これはポリアルキレングリコール、より好ましくはポリエチレングリコールである)、および/または医薬成分、好ましくは第2の医薬添加剤、より好ましくはα−トコフェロール、および/または任意選択的に存在する第3構成成分の融点/溶融域未満である。
−T1は、25℃〜115℃、または30℃〜110℃、より好ましくは35℃〜105℃、または40℃〜100℃、さらに好ましくは45℃〜95℃、または50℃〜90℃、より一層好ましくは55℃〜85℃、最も好ましくは60℃〜80℃、特に65℃〜75℃の範囲内であり;および/または
−T2は、−20℃〜50℃、より好ましくは−10℃〜40℃、さらに好ましくは−5℃〜35℃、より一層好ましくは0℃〜30℃、最も好ましくは5℃〜25℃、特に10℃〜20℃の範囲内である。
(a)医薬添加剤、好ましくは第1の医薬添加剤(これはポリアルキレングリコール、より好ましくはポリエチレングリコールである)を、医薬成分、好ましくは第2の医薬添加剤、より好ましくはα−トコフェロール、および任意選択的に存在する第3構成成分と、押出機の外で混合し、次いで得られた混合物を押出機中に供給するステップ、または
医薬添加剤、好ましくは第1の医薬添加剤(これはポリアルキレングリコール、より好ましくはポリエチレングリコールである)、および医薬成分、好ましくは第2の医薬添加剤、より好ましくはα−トコフェロール、および任意選択的に存在する第3構成成分を、異なるフィーディングポイントで押出機中に供給するステップ、ここで、医薬添加剤、好ましくは第1の医薬添加剤(これはポリアルキレングリコール、より好ましくはポリエチレングリコールである)のためのフィーディングポイントは、医薬成分、好ましくは第2の医薬添加剤、より好ましくはα−トコフェロールのためのフィーディングポイントに対して上流に位置しているか、または逆もしかりである。
(d)粉末を選別するステップ。
−薬理学的に活性な物質、好ましくはオピオイド、および/または
−好ましくは少なくとも200,000g/mol、より好ましくは少なくとも500,000g/mol、さらに好ましくは少なくとも750,000g/mol、より一層好ましくは少なくとも1,000,000g/molの、特に1,000,000g/mol〜10,000,000g/molの範囲内の重量平均分子量を有する、高分子量ポリアルキレンオキシド、好ましくはポリエチレンオキシド;および/または
−セルロースエーテル、好ましくはヒドロキシプロピルメチルセルロースまたはヒドロキシプロピルセルロース、
と一緒に含む、粉末状医薬組成物を製剤化するステップを含む。
α−トコフェロール−ポリエチレングリコール6000プレブレンドを、二軸スクリュー押出機Leistritz ZSE27タイプにより製造した。
・Hosokawa−Alpine(ドイツ)(例2)
・Nuova Guseo(イタリア)(例3)
例2−プレブレンドのクライオミリング− Hosokawa−Alpine:
微細な粉末状医薬組成物を得るために、α−トコフェロール/PEGを含む例1のプレブレンドを、引き続きクライオミリングに付した。
実施例1のプレブレンド材料を、スロットルフィーディングデバイスに仕込んだ。上記材料を液体窒素と接触させ、脆化させた。冷却した材料を、回転プレートビーターならびに0.5および0.8mmの篩を備えた粉砕系に落下させた。
4.1 例2および3で得られたクライオミリングで粉砕されたブレンドをそれぞれ、薬剤生成物製剤の他の成分とブレンドした。上記ブレンド内のα−トコフェロールの含量均一性および物理的特性(すなわち流動性、密度、流動分布(PSD))を調べた。
以下を用いる3つのブレンディングトライアル(同一の質および量の組成物):
リファレンス 14%α−トコフェロール/PEG 市販のブレンド
14%α−トコフェロール/PEG材料(Hosokawa製によりクライオミリングで粉砕した、例2)
14%α−トコフェロール/PEG材料(Nuova Guseo製によりクライオミリングで粉砕した、例3)
全体のバッチサイズは48kgであった。
なお、本願は、特許請求の範囲に記載の発明に関するものであるが、他の態様として以下も包含し得る。
1.医薬添加剤および医薬成分を含み、上記医薬添加剤がポリアルキレングリコールである粉末状の医薬組成物を製造する方法であって;
(c)上記医薬添加剤および上記医薬成分の混合物を周囲温度より低い温度で粉砕するステップ、
を含む方法。
2.上記の周囲温度より低い温度が最大で−10℃である、上記1に記載の方法。
3.ステップ(c)が、冷却系と、粉砕される材料に機械的衝撃を付与するための手段を含むミリングチャンバーとを備えるクライオミルにより行われる、上記1または2に記載の方法。
4.上記クライオミルが、所望の粒度の材料がミリングチャンバーを出ることを可能にするが、より粗い材料はミリングチャンバー内に保持する篩を備えている、上記3に記載の方法。
5.上記クライオミルが、ボールミル、コロイドミル、コニカルミル、ディスインテグレーター、ディスクミル、エッジミル、製粉ミル、ハンマーミル、ジェットミル、ペレットミル、遊星ミル、プレートミル、撹拌ミルおよび振動ミルからなる群から選択される、上記3または4に記載の方法。
6.以下の先行ステップ:
(b)上記医薬添加剤と上記医薬成分との混合物を、上記混合物の液体溶融物が押出機において凝固でき、粉末の形態で押出機を出ることができる温度プロファイルで、押出機において押し出すステップ、
を含む、上記1〜5のいずれか1つに記載の方法。
7.以下の先行ステップ:
(a)上記医薬添加剤を上記医薬成分と押出機の外で混合し、次いで得られた混合物を押出機中に供給するステップ、あるいは
上記医薬添加剤および上記医薬成分を、異なるフィーディングポイントで押出機中に供給するステップ、ここで、上記医薬添加剤のためのフィーディングポイントは、上記医薬成分のためのフィーディングポイントに対して上流に位置しているか、またはその逆である、
を含む、上記6に記載の方法。
8.ステップ(a)において、上記医薬成分を、溶融した医薬添加剤に溶解するか、またはその逆である、上記7に記載の方法。
9.以下の後続ステップ:
(d)粉末を選別するステップ、
を含む、上記1〜8のいずれか1つに記載の方法。
10.ステップ(b)において上記温度プロファイルが、温度T 1 〜温度T 2 への温度勾配を含み、ここでT 1 >T 2 であり、そして、
−T 1 は、上記医薬添加剤および/または上記医薬成分の融点/溶融域より高く;および/または
−T 2 は、上記医薬添加剤および/または上記医薬成分の融点/溶融域より低い、
上記6〜9のいずれか1つに記載の方法。
11.上記粉末状医薬組成物が最大で100μmの平均粒度を有する、上記1〜10のいずれか1つに記載の方法。
12.上記医薬添加剤が親水性であり、上記医薬成分が疎水性であるか、またはその逆である、上記1〜11のいずれか1つに記載の方法。
13.上記医薬成分が第2の医薬添加剤である、上記1〜12のいずれか1つに記載の方法。
14.
−上記ポリアルキレングリコールがポリエチレングリコールであり、および/または
−上記の第2の医薬添加剤がα−トコフェロールである、
上記13に記載の方法。
15.ポリアルキレングリコールとトコフェロール成分との相対重量比が、1000:1〜5:1の範囲内である、上記14に記載の方法。
Claims (13)
- 医薬添加剤および医薬成分を含み、上記医薬添加剤が最大で50,000g/molの分子量を有する親水性ポリアルキレングリコールであり、上記医薬成分が疎水性の第2の医薬添加剤である粉末状の医薬組成物を製造する方法であって;
(c)上記医薬添加剤および上記医薬成分の混合物を周囲温度より低い温度で粉砕するステップ、
を含み、
上記の周囲温度より低い温度が、最大で0℃であり、そして
上記医薬添加剤と上記医薬成分との相対重量比が1000:1〜5:1の範囲内である方法。 - 上記の周囲温度より低い温度が最大で−10℃である、請求項1に記載の方法。
- ステップ(c)が、冷却系と、粉砕される材料に機械的衝撃を付与するための手段を含むミリングチャンバーとを備えるクライオミルにより行われる、請求項1または2に記載の方法。
- 上記クライオミルが、所望の粒度の材料がミリングチャンバーを出ることを可能にするが、より粗い材料はミリングチャンバー内に保持する篩を備えている、請求項3に記載の方法。
- 上記クライオミルが、ボールミル、コロイドミル、コニカルミル、ディスインテグレーター、ディスクミル、エッジミル、製粉ミル、ハンマーミル、ジェットミル、ペレットミル、遊星ミル、プレートミル、撹拌ミルおよび振動ミルからなる群から選択される、請求項3または4に記載の方法。
- 以下の先行ステップ:
(b)上記医薬添加剤と上記医薬成分との混合物を、上記混合物の液体溶融物が押出機において凝固でき、粉末の形態で押出機を出ることができる温度プロファイルで、押出機において押し出すステップ、
を含む、請求項1〜5のいずれか1つに記載の方法。 - 以下の先行ステップ:
(a)上記医薬添加剤を上記医薬成分と押出機の外で混合し、次いで得られた混合物を押出機中に供給するステップ、あるいは
上記医薬添加剤および上記医薬成分を、異なるフィーディングポイントで押出機中に供給するステップ、ここで、上記医薬添加剤のためのフィーディングポイントは、上記医薬成分のためのフィーディングポイントに対して上流に位置しているか、またはその逆である、
を含む、請求項6に記載の方法。 - ステップ(a)において、上記医薬成分を、溶融した医薬添加剤に溶解するか、またはその逆である、請求項7に記載の方法。
- 以下の後続ステップ:
(d)粉末を選別するステップ、
を含む、請求項1〜8のいずれか1つに記載の方法。 - ステップ(b)において上記温度プロファイルが、温度T1〜温度T2への温度勾配を含み、ここでT1>T2であり、そして、
−T1は、上記医薬添加剤および/または上記医薬成分の融点/溶融域より高く;および/または
−T2は、上記医薬添加剤および/または上記医薬成分の融点/溶融域より低い、
請求項6〜9のいずれか1つに記載の方法。 - 上記粉末状医薬組成物が最大で100μmの平均粒度を有する、請求項1〜10のいずれか1つに記載の方法。
- −上記ポリアルキレングリコールがポリエチレングリコールであり、および/または
−上記の第2の医薬添加剤がα−トコフェロールである、
請求項1〜11のいずれか1つに記載の方法。 - ポリアルキレングリコールとトコフェロール成分との相対重量比が、1000:1〜5:1の範囲内である、請求項12に記載の方法。
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CA2931553A1 (en) | 2015-06-04 |
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BR112016010482A2 (ja) | 2017-08-08 |
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