JP7412329B2 - 経口用組成物及びその調製方法 - Google Patents
経口用組成物及びその調製方法 Download PDFInfo
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Description
i)前記少なくとも1つの有効成分及び前記少なくとも1つの賦形剤を造粒機中で混合し、湿潤顆粒を得る工程と、
ii)得られた湿潤顆粒をトレー上に延ばし、15~25℃の間で2~24時間放置する工程と、
iii)工程ii)の後に得られた顆粒を、錠剤プレス機を用いて圧縮する工程と、
iv)固形組成物を収集する工程と
の連続する工程を含む。
- 0.01~20.00質量%の間、好ましくは1.00~10質量%の間の前記少なくとも1つの有効成分と、
- 15.00~30.00質量%の間、好ましくは約20質量%の前記少なくとも1つの嗜好性材料と、
- 15.00~35.00質量%の間、好ましくは20.00~30.00質量%の間の前記少なくとも1つの保湿剤と、
- 20.00~40.00質量%の間、好ましくは約24.50質量%の前記少なくとも1つの結合剤と、
- 0.10~10.00質量%の間、好ましくは約5.00質量%の前記少なくとも1つの滑沢剤と、
- 10.00~30.00質量%の間、好ましくは15.00~25.00質量%の間の前記少なくとも1つの充填剤と、
- 0.10~10.00質量%の間、好ましくは約4.00質量%の前記少なくとも1つの崩壊剤と
を含む。
i)a)前記少なくとも1つの有効成分、前記少なくとも1つの嗜好性材料、前記少なくとも1つの結合剤、前記少なくとも1つの充填剤、前記少なくとも1つの滑沢剤、及び前記少なくとも1つの崩壊剤を造粒機中で混合する工程と、
i)b)前記少なくとも1つの保湿剤を工程i)a)のブレンドに噴霧し、混合して湿潤顆粒を得る工程と、
ii)a)工程i)b)の後に得られた湿潤顆粒を延ばし、15~25℃の間で2~24時間放置する工程と、
ii)b)工程ii)a)の後に得られた顆粒を、振動造粒機を用いてミリングし、次いで800~2000μmのふるい、好ましくは1250μmのふるいにかける工程と、
ii)c)任意選択により、顆粒を室温で2~24時間放置する工程と、
iii)a)任意選択により、工程ii)b)又はii)c)の後に得られた顆粒を、少なくとも1つの崩壊剤及び/又は少なくとも1つの充填剤とブレンダーでブレンドする工程と、
iii)b)工程ii)b)、ii)c)、又はiii)a)の後に得られた顆粒を、少なくとも1つの滑沢剤とブレンダーでブレンドする工程と、
iii)c)工程iii)b)の後に得られたブレンドを、錠剤プレス機を用いて圧縮する工程と、
iv)固形組成物を収集する工程と
の連続した工程を含む方法に関する。
i)前記少なくとも1つの有効成分及び前記少なくとも1つの賦形剤を造粒機中で混合し、湿潤顆粒を得る工程と、
ii)湿潤顆粒をトレー上に延ばし、15~25℃の間で2~24時間放置する工程と、
iii)工程ii)の後に得られた顆粒を、錠剤プレス機を用いて圧縮する工程と、
iv)固形組成物を収集する工程と
の連続する工程を含む、方法を提供する。
本発明による方法によって得られた固形組成物は、典型的な錠剤とソフトチューの間の中間の剤形と考えることができ、「軟質錠剤」に相当する。
本明細書に開示される固形組成物又は「軟質錠剤」の調製方法は、i)造粒工程と、ii)顆粒を放置する工程と、iii)圧縮工程と、及びiv)収集する工程とを含む。より詳細には、この方法は、
i)前記少なくとも1つの有効成分及び前記少なくとも1つの賦形剤を造粒機中で混合し、湿潤顆粒を得る工程と、
ii)得られた湿潤顆粒をトレー上に延ばし、15~25℃の間で2~24時間放置する工程と、
iii)工程ii)の後に得られた顆粒を、錠剤プレス機を用いて圧縮する工程と、
iv)固形組成物を収集する工程と
の連続する工程を含む。
i)a)前記少なくとも1つの有効成分、前記少なくとも1つの嗜好性材料、前記少なくとも1つの結合剤、前記少なくとも1つの充填剤、前記少なくとも1つの滑沢剤、及び前記少なくとも1つの崩壊剤を造粒機中で混合する工程と、
i)b)前記少なくとも1つの保湿剤を工程i)a)のブレンドに噴霧し、混合して湿潤顆粒を得る工程と、
ii)a)工程i)b)の後に得られた湿潤顆粒をトレー上に延ばし、15~25℃の間で2~24時間放置する工程と、
ii)b)工程ii)a)の後に得られた顆粒を、振動造粒機を用いてミリングし、次いで好ましくは800~2000μmのふるい、好ましくは1250μmのふるいにかける工程と、
ii)c)任意選択により、顆粒を室温で2~24時間放置する工程と、
iii)a)任意選択により、工程ii)b)又は工程ii)c)の後に得られた顆粒を、少なくとも1つの崩壊剤及び/又は少なくとも1つの充填剤とブレンダーでブレンドする工程と、
iii)b)工程ii)b)、ii)c)、又はiii)a)の後に得られた顆粒を、少なくとも1つの滑沢剤とブレンダーでブレンドする工程と、
iii)c)工程iii)b)の後に得られたブレンドを、錠剤プレス機を用いて圧縮する工程と、
iv)固形組成物を収集する工程と
の連続する工程を含む方法である。
- 0.01~20.00質量%の間の範囲、好ましくは1.00~10.00質量%の間の範囲の前記少なくとも1つの有効成分と、
- 15.00~30.00質量%の間の範囲、好ましくは約20.00質量%の前記少なくとも1つの嗜好性材料と、
- 15.00~35.00質量%の間の範囲、好ましくは20.00~35.00質量%の間の範囲の前記少なくとも1つの保湿剤と、
- 20.00~40.00質量%の間の範囲、好ましくは約24.50質量%の前記少なくとも1つの結合剤と、
- 0.01~10.00質量%の間の範囲、好ましくは0.10~5.00質量%の間の範囲の前記少なくとも1つの滑沢剤と、
- 0.10~20.00質量%の間の範囲の前記少なくとも1つの充填剤と、
- 0.10~10.00質量%の間の範囲、好ましくは約4.00質量%の前記少なくとも1つの崩壊剤と
を顆粒の全体の質量に対して含む。
- 83.50~99.98質量%の間の範囲、好ましくは約90.75質量%の放置する工程ii)、並びに任意選択によりミリングする工程ii)b)及びii)c)の後に得られた顆粒と、
- 0.01~15.00質量%の間の範囲、好ましくは約7.50質量%の前記少なくとも1つの充填剤、好ましくはセルロース、ラクトース、糖、クロスカルメロース、及びそれらの混合物と、
- 0.01~2.50質量%の間の範囲、好ましくは約1.75質量%の前記滑沢剤、好ましくはステアリン酸マグネシウム、ステアリン酸、及びそれらの混合物と
を含む。
- 0.01~20.00質量%の間、好ましくは1.00~10.00質量%の間の前記少なくとも1つの有効成分と、
- 15.00~30.00質量%の間、好ましくは約20.00質量%の前記少なくとも1つの嗜好性材料と、
- 15.00~35.00質量%の間、好ましくは20.00~30.00質量%の間の前記少なくとも1つの保湿剤と、
- 20.00~40.00質量%の間、好ましくは約24.50質量%の前記少なくとも1つの結合剤と、
- 0.10~10.00質量%の間、好ましくは約5.00質量%の前記少なくとも1つの滑沢剤と、
- 10.00~30.00質量%の間、好ましくは15.00~25.00質量%の間の前記少なくとも1つの充填剤と、
- 0.10~10.00質量%の間、好ましくは約4.00質量%の前記少なくとも1つの崩壊剤と
を含む。
(ドキシサイクリン)を含む軟質錠剤を製造する方法
造粒機中で、全ての粉末成分を、以下に規定する量で混合する。
ミルベマイシン及びプラジカンテルを含む軟質錠剤組成物
造粒機中で、全ての粉末成分を、以下に規定する量で混合する。
Claims (3)
- 少なくとも1つの有効成分、少なくとも1つの嗜好性材料、少なくとも1つの結合剤、少なくとも1つの充填剤、少なくとも1つの崩壊剤、及び、少なくとも1つの滑沢剤を含む少なくとも1つの賦形剤、並びに、保湿剤を含む固形組成物を調製するための方法であって、
i)前記少なくとも1つの有効成分、前記少なくとも1つの賦形剤、及び、前記保湿剤を造粒機中で混合し、湿潤顆粒を得る工程であって、前記有効成分がドキシサイクリン塩酸塩であり、前記嗜好性材料が酵母抽出物及びチキン風味を含み、前記結合剤がマルトデキストリン、アルファ化デンプン、グアーゴム、及び、キサンタンゴムを含み、前記充填剤がブドウ糖及び微結晶性セルロースを含み、前記崩壊剤がクロスカルメロースを含み、前記滑沢剤がPEG 6000を含み、前記保湿剤が、ソルビトール、グリセリン、及びダイズ油を含む、工程と、
ii)得られた湿潤顆粒をトレー上に延ばし、15~25℃の間で2~24時間放置する工程と、
ii')前記顆粒を微結晶性セルロース、ステアリン酸、ステアリン酸マグネシウムとブレンドする工程と、
iii)工程ii')の後に得られた顆粒を、錠剤プレス機を用いて圧縮する工程と、
iv)固形組成物を収集する工程と
の連続する工程を含み、
得られる固形組成物が、以下の成分を含む、
- 前記固形組成物が、少なくとも1つの保存剤、少なくとも1つの抗酸化剤、及び/又は、少なくとも1つのキレート剤を更に含む、請求項1に記載の方法。
- i)a)前記少なくとも1つの有効成分、前記少なくとも1つの嗜好性材料、前記少なくとも1つの結合剤、前記少なくとも1つの充填剤、前記少なくとも1つの滑沢剤、及び前記少なくとも1つの崩壊剤を造粒機中で混合する工程と、
i)b)前記保湿剤を工程i)a)のブレンドに噴霧し、混合して湿潤顆粒を得る工程と、
ii)a)工程i)b)の後に得られた湿潤顆粒をトレー上に延ばし、15~25℃の間で2~24時間放置する工程と、
ii)b)工程ii)a)の後に得られた顆粒を、振動造粒機を用いてミリングし、次いで800~2000μmのふるいにかける工程と、
iii)a)工程ii)b)の後に得られた顆粒を、少なくとも1つの滑沢剤とブレンダーでブレンドする工程と、
iii)b)工程iii)a)の後に得られたブレンドを、錠剤プレス機を用いて圧縮する工程と、
iv)固形組成物を収集する工程と
の連続する工程を含む、請求項1又は2に記載の方法。
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USD941985S1 (en) | 2020-04-07 | 2022-01-25 | Nutramax Laboratories, Inc. | Dietary supplement |
USD941458S1 (en) | 2020-08-11 | 2022-01-18 | Nutramax Laboratories, Inc. | Dietary supplement |
USD942609S1 (en) | 2020-08-11 | 2022-02-01 | Nutramax Laboratories, Inc. | Dietary supplement |
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GB202212379D0 (en) * | 2022-08-25 | 2022-10-12 | GlaxoSmithKline Consumer Healthcare UK IP Ltd | Novel toothpaste tablet composition |
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US20230146514A1 (en) | 2023-05-11 |
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