JP5154924B2 - ジェランガムを含む膨張可能な投与形態 - Google Patents
ジェランガムを含む膨張可能な投与形態 Download PDFInfo
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- JP5154924B2 JP5154924B2 JP2007511867A JP2007511867A JP5154924B2 JP 5154924 B2 JP5154924 B2 JP 5154924B2 JP 2007511867 A JP2007511867 A JP 2007511867A JP 2007511867 A JP2007511867 A JP 2007511867A JP 5154924 B2 JP5154924 B2 JP 5154924B2
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- Prior art keywords
- blend
- sodium
- acid
- formulation
- spoon
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- 229920002148 Gellan gum Polymers 0.000 title claims abstract description 56
- 239000000216 gellan gum Substances 0.000 title claims abstract description 49
- 235000010492 gellan gum Nutrition 0.000 title claims abstract description 48
- 239000002552 dosage form Substances 0.000 title abstract description 74
- 239000000203 mixture Substances 0.000 claims abstract description 538
- 238000012360 testing method Methods 0.000 claims abstract description 104
- 239000013543 active substance Substances 0.000 claims abstract description 65
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 49
- 239000000499 gel Substances 0.000 claims abstract description 42
- 229920000642 polymer Polymers 0.000 claims abstract description 39
- 238000002156 mixing Methods 0.000 claims abstract description 20
- 239000007787 solid Substances 0.000 claims abstract description 14
- 150000007524 organic acids Chemical class 0.000 claims abstract description 13
- 235000005985 organic acids Nutrition 0.000 claims abstract description 11
- 239000002357 osmotic agent Substances 0.000 claims abstract description 10
- 239000002253 acid Substances 0.000 claims abstract description 9
- 239000003792 electrolyte Substances 0.000 claims abstract description 8
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 122
- -1 sodium citrate Organic acids Chemical class 0.000 claims description 114
- 239000004615 ingredient Substances 0.000 claims description 78
- 238000009472 formulation Methods 0.000 claims description 73
- 239000008187 granular material Substances 0.000 claims description 70
- 239000000126 substance Substances 0.000 claims description 69
- 239000000843 powder Substances 0.000 claims description 51
- 235000011187 glycerol Nutrition 0.000 claims description 41
- 239000007788 liquid Substances 0.000 claims description 40
- 239000011159 matrix material Substances 0.000 claims description 36
- 239000002245 particle Substances 0.000 claims description 33
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 32
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 32
- 239000000811 xylitol Substances 0.000 claims description 32
- 235000010447 xylitol Nutrition 0.000 claims description 32
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 32
- 229960002675 xylitol Drugs 0.000 claims description 32
- 239000008399 tap water Substances 0.000 claims description 31
- 235000020679 tap water Nutrition 0.000 claims description 31
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 27
- 239000003349 gelling agent Substances 0.000 claims description 26
- 235000002639 sodium chloride Nutrition 0.000 claims description 26
- 239000002904 solvent Substances 0.000 claims description 19
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 18
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 18
- 150000003839 salts Chemical class 0.000 claims description 18
- 238000013270 controlled release Methods 0.000 claims description 17
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 16
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 15
- 239000011230 binding agent Substances 0.000 claims description 15
- 239000011859 microparticle Substances 0.000 claims description 15
- 239000001509 sodium citrate Substances 0.000 claims description 15
- 239000003125 aqueous solvent Substances 0.000 claims description 14
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 14
- 235000011083 sodium citrates Nutrition 0.000 claims description 14
- 235000000346 sugar Nutrition 0.000 claims description 14
- 239000000796 flavoring agent Substances 0.000 claims description 13
- 235000019634 flavors Nutrition 0.000 claims description 13
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 10
- 239000000853 adhesive Substances 0.000 claims description 10
- 230000001070 adhesive effect Effects 0.000 claims description 10
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 10
- 235000003599 food sweetener Nutrition 0.000 claims description 10
- 238000004519 manufacturing process Methods 0.000 claims description 10
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- 239000003765 sweetening agent Substances 0.000 claims description 10
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 9
- 235000015165 citric acid Nutrition 0.000 claims description 9
- 238000002360 preparation method Methods 0.000 claims description 9
- 244000247812 Amorphophallus rivieri Species 0.000 claims description 8
- 235000001206 Amorphophallus rivieri Nutrition 0.000 claims description 8
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 8
- 229920002752 Konjac Polymers 0.000 claims description 8
- CSNNHWWHGAXBCP-UHFFFAOYSA-L Magnesium sulfate Chemical group [Mg+2].[O-][S+2]([O-])([O-])[O-] CSNNHWWHGAXBCP-UHFFFAOYSA-L 0.000 claims description 8
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 8
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical group [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 8
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 8
- 239000003205 fragrance Substances 0.000 claims description 8
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- 239000000252 konjac Substances 0.000 claims description 8
- 235000010485 konjac Nutrition 0.000 claims description 8
- KWGKDLIKAYFUFQ-UHFFFAOYSA-M lithium chloride Chemical compound [Li+].[Cl-] KWGKDLIKAYFUFQ-UHFFFAOYSA-M 0.000 claims description 8
- 239000011780 sodium chloride Substances 0.000 claims description 8
- 239000000654 additive Substances 0.000 claims description 7
- 235000010443 alginic acid Nutrition 0.000 claims description 7
- 229920000615 alginic acid Polymers 0.000 claims description 7
- 150000001768 cations Chemical class 0.000 claims description 7
- 235000010987 pectin Nutrition 0.000 claims description 7
- 239000001814 pectin Substances 0.000 claims description 7
- 229920001277 pectin Polymers 0.000 claims description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims description 7
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 7
- 229920001285 xanthan gum Polymers 0.000 claims description 7
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims description 6
- 108010010803 Gelatin Proteins 0.000 claims description 6
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims description 6
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 6
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 6
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 6
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims description 6
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 6
- 239000008273 gelatin Substances 0.000 claims description 6
- 229940014259 gelatin Drugs 0.000 claims description 6
- 229920000159 gelatin Polymers 0.000 claims description 6
- 235000019322 gelatine Nutrition 0.000 claims description 6
- 235000011852 gelatine desserts Nutrition 0.000 claims description 6
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 6
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims description 6
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 5
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 5
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 5
- 239000002585 base Substances 0.000 claims description 5
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 5
- 239000000872 buffer Substances 0.000 claims description 5
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- 229920002678 cellulose Polymers 0.000 claims description 5
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- 238000002425 crystallisation Methods 0.000 claims description 5
- 239000008103 glucose Substances 0.000 claims description 5
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- 229910052751 metal Inorganic materials 0.000 claims description 5
- 239000002184 metal Substances 0.000 claims description 5
- 239000003002 pH adjusting agent Substances 0.000 claims description 5
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 4
- 229920001817 Agar Polymers 0.000 claims description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 4
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 4
- RBNPOMFGQQGHHO-UWTATZPHSA-N D-glyceric acid Chemical compound OC[C@@H](O)C(O)=O RBNPOMFGQQGHHO-UWTATZPHSA-N 0.000 claims description 4
- 229920002907 Guar gum Polymers 0.000 claims description 4
- 229920000084 Gum arabic Polymers 0.000 claims description 4
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- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
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- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 4
- 229920001615 Tragacanth Polymers 0.000 claims description 4
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 claims description 4
- 235000010489 acacia gum Nutrition 0.000 claims description 4
- 239000000205 acacia gum Substances 0.000 claims description 4
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 4
- 230000010933 acylation Effects 0.000 claims description 4
- 238000005917 acylation reaction Methods 0.000 claims description 4
- WNLRTRBMVRJNCN-UHFFFAOYSA-N adipic acid Chemical compound OC(=O)CCCCC(O)=O WNLRTRBMVRJNCN-UHFFFAOYSA-N 0.000 claims description 4
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- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 4
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- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 4
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- IOLCXVTUBQKXJR-UHFFFAOYSA-M potassium bromide Chemical compound [K+].[Br-] IOLCXVTUBQKXJR-UHFFFAOYSA-M 0.000 claims description 4
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Description
一つの観点において、本発明は一以上の活性物質の経口投与用媒体に関し、その媒体は、所定量の水性溶剤の添加により、剪断力または他の混合力を用いる必要なくして、5分以内に、膨張および/またはゲル化し、膨張した媒体の構造がソフトプリンのそれと同様であり、#4 LVスピンドルを有するブルックフィールド粘度計により、6 rpmおよび20〜25℃で測定したときに、少なくとも約10,000 cpsの粘度を有するように、最適な水拡散を許容する構造にアレンジされたジェランガムを含む。
媒体および組成物
前記のように、本発明は、一以上の活性物質の経口投与用媒体に関し、その媒体は、所定量の水性溶剤の添加により、剪断力または他の混合力を用いないで、5分以内に、膨張および/またはゲル化し、膨張した媒体のキメがソフトプリンのそれと同様であり、#4 LVスピンドルを有するブルックフィールド粘度計により、6 rpmおよび20〜25℃で測定したときに、少なくとも約10,000 cpsの粘度を有するように、最適な水拡散を許容する構造にアレンジされたジェランガムを含む。
膨張するために、ゲルは水の吸収を必要とし、これは寸法変化に関連し、水分子が物質の内部構造へ入り込むことが必要である。水分子の小さいサイズおよび一般的に物質が実質的に無定形である事実は、水素結合の良好な可能性を提供し、水分子が浸透し、その結果膨張することを可能にする。水の吸収およびヒドロゲルから薬物の脱着の初期のメカニズムは拡散であり、巨大分子鎖間の利用可能な空間を通して起こる。
ヒドロゲルの膨張動力学は、拡散律速(Fickian)および緩和−制御(relaxation-controlled)(non-Fikian)膨張として分類され得る。
ヒドロゲルの機械的性質は、医薬的適用に関連し、本件の場合においては、適用の前に、形成されたゲルが輸送装置をずり落ちないことが望まれる。
例えば、塩を添加することにより架橋結合の度合を変えることは、飽和点までに、より強固なゲルの状態をもたらす。それゆえ、比較的強固で、そしてまだ弾力のあるヒドロゲルを達成するために架橋結合の最適な度合がある。例えば、高いイオン含量で、多糖類は相互に連結し、弱められたゲルネットワークを形成し得る不溶性の凝固を形成するであろう。
官能性はアシル化の度合および存在するイオンに依存する。低アシル化されたゲル化剤は、軟らかく、弾力性で、透明で、柔軟性のゲルを形成するが、もしそれが脱アシル化されたなら、それは、硬く、非弾性の脆性ゲルを形成するだろう。重要な特色は、ジェランガムが、脱水後に不可逆的なフィルムを形成し得る不可逆的なゲル化の性質であり、それは脱水によるゲル化を防止するであろう。ゲル−溶液転移は、濃度に依存し、約50℃で起こる。熱可逆的ゲルは、カチオンの存在下、低濃度(0.1重量%)〜極低濃度(0.005重量%)でさえ、冷却で形成される。
コンニャクグルコマンナン(KGM)の化学構造は、以下に示される。KGMの分子量は、コンニャクの種類または品種、加工方法および原料の保存時間により、1,000,000〜2,000,000ダルトンで変化する。
好ましい態様において、ジェランガムは、媒体中に水の好適な分布を可能にするために、25メッシュ〜300メッシュ内の平均粒子径を有する。
特別な態様において、ジェランガムは、一つの繰返しにつき一つのグリセレートおよび二回の繰返しごとに一つのアセテートのアシル化の度合を有する。
「浸透圧剤」の用語は、使用の環境からマトリックスの中への水または(水性)溶剤の移動のための推進力を生むあらゆる剤を意味する。典型的な浸透圧剤は、水膨張性であるかまたは水可溶性である。
他の製剤成分より電解質の大きい親水性は、周囲のポリマーおよび薬物分子に比較して、優先してそれの水和を可能にする。この周辺のマトリックスの固化は、水和層内に制御可能な微細な環境を生じ、そしてイオン力価を添加された水からマトリックスに変動できる頑強な製剤を再度作る。
例えば、上部消化管の酸性領域を通して、内部の投与形態のpHを保つアルカリ化剤の使用がうまく確立される。
摂取により、胃液が投与形態内に入り、その組成物の水和が生じ、その賦形剤のpHおよび放出制御特性を活性化する。
本製剤は、酸性溶剤中への溶解速度を遅らせるため、および/またはpH6.8での緩衝液中への溶解速度を増加するため、または経時的に薬物の安定性を保証し、そして実質的にpHに依存しない溶解度プロファイルを与えるために、有機酸も含み得る。
有機酸は、pHの範囲をカバーするために、そして放出メカニズムを制御することを促進するために、溶解度とpKa値の範囲をカバーするために選ばれる。その目的は、6.8の緩衝液と0.1M HCl中の両方で同じ放出時間を得ることである。医薬的に許容される有機酸は、例えば、安息香酸、コハク酸、クエン酸およびアジピン酸であるが、他の医薬的に認められた有機酸をも含み得る。
静電反発の増加は、例えば、一価および/または二価の金属イオン(製剤中に元から存在するか導入される)を加えることにより、飽和点まで膨張を促進もする。膨張の間、物質を広げるのに必要な推進力は、同じ電荷を有する異なるイオン基間の静電反発である。このように、対イオンの性質はそのように荷電されたゲル様の系の膨張の度合に極めて重要である。製剤中のイオン含量を変えることは、水の取り込みに影響を及ぼすであろう。イオン(イオン対)の性質は、イオン対の異なる解離能力のため、水吸収の特性に重大な効果を有する。
イオン対は、水分子に関して、ヒドロゲルと競合し、それによりそれぞれ水和を増加させ、ヒドロゲルの溶解性を減少させ、それはゲル形成を安定させ得る。
架橋の比率は、ヒドロゲルの膨張をもたらす最も重要な因子の一つである。それは、ポリマー繰返し単位のモルに対する架橋剤のモルの比として定義される。架橋比が高くなればなるほど、より多くの架橋剤がヒドロゲル構造に取り込まれる。高く架橋されたヒドロゲルは、より強固な構造を有し、より低い架橋比を有する同じヒドロゲルと比較して、より少なく膨張するであろう。架橋はポリマー鎖の可動性を妨害し、それゆえ膨張比を低下させる。ポリマーの化学構造も、ヒドロゲルの膨張比に影響を及ぼし得る。親水性基を含むヒドロゲルは、疎水性基を含むものと比較して、より高い度合で膨張する。疎水性基は、水の存在下に崩壊し、そのようにして水分子へ曝されるそれらを最小にする。
pHに依存して膨張するヒドロゲルは、適当なpHおよびイオン力価の水性溶剤中でイオン化される。静電反発の結果、ネットワーク中の水の取り込みは増加する。イオン性のヒドロゲルは、カルボン酸のようなペンダント基を有する膨れたポリマーネットワークであり、それは外部pHを変えることにより、それらの動的および平衡挙動において、突然または漸進的な変化を示す。これらのゲルにおいて、イオン化は、周囲のpHがイオン化基のpKaを超えるときに起こる。
本発明による媒体または組成物は、一以上の医薬的に許容される賦形剤または添加剤も含み得る。
湿潤剤は、例えば、医薬的に許容されるアニオン性界面活性剤、カチオン性界面活性剤、両性(両親媒性/両性親和性(amphophilic))界面活性剤、およびポロキサマー、PEGおよびPEOを含む非イオン性界面活性剤;メチル硫酸ナトリウム、ラウリル硫酸ナトリウムなどのようなアルキル基が1〜14の炭素原子であるアルカン硫酸金属塩ならびにジオクチルナトリウムスルホスクシネートからなる群から一つ以上選択されて用いられ得る。
本発明の具体的な態様において、媒体または組成物はさらにグリセロールを含む。以下の実施例を参照。
遅く膨張する性質は、水性ゲルを制御された薬物輸送にも役立たせるものであるが、多くの適用は、乾燥水性ゲルの速い膨張(すなわち、時間よりむしろ分または秒の間に膨張すること)を要求する。
水溶性のポリサッカライド、例えばゲランガムの存在は、各ゲランガム粒子の回りにフィルム層が形成されるため、水中に分散することを困難にし得る。このことは、大きなアグロメレート(塊)の形成に導き、それは、その保護フィルム層のため、水分子が浸透することを非常に困難にする。
例えば、親水性賦形剤の組み込みによる、異なる製剤の手始めは、水和および膨張速度を変え得る。通常、速い膨張は、乾燥水性ゲルの非常に小さな粒子を作ることによりなされる。微粒子の極めて短い拡散経路の長さは、およそ秒または分の間に完全な膨張を可能にする。
公知の賦形剤が、制御可能な水分散/薬物放出機構を得るために、分子または分散された剤形と一緒にブレンドされ得る。
本発明による媒体は、例えば、粉末ブレンドの形態、顆粒、ビーズ、オブラートまたはペレットの形態、または顆粒の形態のようなあらゆる好適な形態を有し得る。もし存在するなら、あらゆる添加剤または賦形剤が、例えば顆粒等の中に組み込まれ得るか、またはそれは例えば顆粒の形成後に、大まかに加えられ得る。
前記のように、本発明は、一以上の活性物質、および所定量の水性溶剤の添加により、剪断力または他の混合力を用いる必要なくして、5分以内に、組成物が膨張および/またはゲル化し、膨張した組成物のキメがソフトプリンのそれと同様であり、#4 LVスピンドルを有するブルックフィールド粘度計により、6 rpmおよび20〜25℃で測定したときに、少なくとも約10,000 cpsの粘度を有するように、最適な水拡散を許容する構造にアレンジされたジェランガムを含む経口投与用医薬組成物にも関する。
本発明の他の観点に関する、前記の詳細で具体的な記述の全ては、必要な変更を加えて、この観点に適用される。
膨張が制御されたシステム:
親水性マトリックスからなり、その製剤からの薬物放出が、溶媒分子の内部への流れおよびポリマーマトリックスの続く膨張により制御される製剤は、膨張が制御されたシステムとしばしば呼ばれる。
拡散も制御されているマトリックスシステムにおいて、薬物は水性ゲルのネットワーク全体に溶解するか、または拡散する。
初期の薬物含量
API溶解性
マトリックス形成ポリマーのタイプ
親水性/疎水性賦形剤のタイプおよび含量
を含み得る。
輸送システムの進展において、(単純化された)三つの重要な現象が、同時に考慮されなければならない。
水、薬物、賦形剤およびほぐされたポリマー鎖の拡散、
ポリマーの水和および膨張、
薬物、賦形剤およびポリマーの溶解。
溶解速度は、しばしば、a)マトリックス内の薬物および他の添加剤の組成およびレベル、b)溶解溶剤中の電解質の組成およびイオン力価により影響を及ぼされる。
一般的に、薬物分子自身の溶解性は、マトリックスシステムおよび輸送サイトの両方における拡散放出の速度および範囲を支配する。拡散が生じるために、最初の工程は、水による薬物の湿潤であり、次いでその溶解により薬物分子が分子の状態で利用できることを可能にする。それゆえ、観察される全放出速度は、(その構造、分子量、pKaにより影響される)薬物溶解度性、ポリマーの性質(親水性/親油性、分子量、くねり)、賦形剤の性質(構造、分子量、溶解性、pKa)ならびにユニット中の薬物/ポリマーおよび賦形剤/ポリマーの相対比の累積効果である。
大量の液体への溶解性、薬物含量、薬物分子の大きさ、および膨張したポリマーネットワーク内の薬物分子の可動性のような種々の因子が、薬物放出の全体的制御に寄与する。
薬物の溶解度を下げるにつれて、薬物放出間の濃度差(マトリックスの場所対大量液体)が減少し、それゆえ、マトリックスからの薬物拡散のための推進力が減少する。これらの条件下での枯渇によるマトリックスの多孔性の減少(増加された初期の薬物の積載による)は、多分、溶解性のより高い薬物の場合より、得られる薬物放出へのより明白な効果を有する。その結果、(相対的放出速度を増加する)重要な初期の薬物積載は、薬物の溶解性の減少につれて増加する。これらの現象は単純ではなく、新しい製剤をデザインするときに考慮されなければならない。
必要ではないが、API、ジェランガム、水性ゲル、および賦形剤は粒状物の形態であるのが好ましい。一般的に、粒子は、マトリックスがマトリックス全体を通して十分にかつ均等に水和できるような大きさであるべきである。分離および結果的に非同質の生成物を防ぐため、より小さな粒子をもつことが有利でもあり得るPVPは除いて、均一の粒子径で製剤化されることが好ましい。好適な粒子径は、350〜500μmである。
特定の態様において、本発明の媒体は、一以上の活性物質を含む。その活性物質は、媒体との混合物の状態で存在し得る。膨張剤および/またはゲル化剤を含む顆粒の状態で存在し得る。それはマイクロカプセル化された形態またはマトリックスに埋め込まれた形態で存在し、そして/またはそれは活性物質の制御された放出を可能にする形態で存在し得る。
1.アセタミノフェン、アスピリン、サリチル酸、サリチル酸メチル、サリチル酸コリン、サリチル酸グリコール、1-メントール、カンファー、メフェナム酸、フルフェナミン酸、インドメタシン、ジクロフェナック、アルクロフェナック、イブプロフェン、ケトプロフェン、ナプロキセン、プロノプロフェン、フェノプロフェン、スリンダック、フェンブフェン、クリダナック、フルビプロフェン、インドプロフェン、プロチジディク酸(protizidic acid)、フェンアザック、トルメチン、チアプロフェン酸、ベンダザック、ブフェキサマック、ピロキシカム、フェニルブタゾン、オキシフェンブタゾン、クロフェゾン、ペンタゾシン、メピリゾールなどのような鎮痛抗炎症剤;
13. ニトログリセリン、イソソルビトールジナイトレート、エリスリトールテトラナイトレートおよびペンタエリスリトールテトラナイトレートのような有機ナイトレート、ジピリダモール、ジラゼプ、トラピジル、トリメタジジンなどのような冠血管拡張剤;
15. チモロール ピンドロール、プロプラノロールなどのようなβ-ブロッカーまたは抗不整脈剤;
17. ニトラゼパム、メプロバマート、フェニトインなどのような抗痙攣剤;
18. イソプレナリン、ベタヒスチン、スコポラミンなどのような目眩用剤;
22. レボドーパ、カルビドーパ、アマンタジン、アポモルフィン、ブロモクリプチン、セレギリン(デプレニル)、トリヘキシフェニジル塩酸塩、ベンズトロピンメシレート、プロシクリジン塩酸塩、バクロフェン、ジアゼパム、ダントロレンなどのようなパーキンソン病、痙縮および急性筋痙攣用薬;
24. コルチコトロピン、オキシトシン、バソプレッシン、唾液ホルモン、甲状腺ホルモン、副腎ホルモン、カリクレイン、インスリン、オキセンドロンなどのような非ステロイドホルモンまたは抗ホルモン;
26. 5-フルオロウラシルおよびその誘導体、クレスチン、ピシバニル、アンシタビン、シタラビンなどのような抗腫瘍剤;
27. リゾチーム、ウロキナーゼなどのような酵素;
29. ピロカルピンなどのような縮瞳薬;コリン、アセチルコリン、メタコリン、カルバコール、ベタネコール、ピロカルピン、ムスカリン、アレコリンなどのようなlo 30.コリン作動性アゴニスト;
32. アトロピン、シクロペントラート、ホマトロピン、スコポラミン、トロピカミド、オイカトロピン、ヒドロキシアンフェタミンなどのような散瞳薬;
34. 例えば、PGE1、PGE2αおよびPGF2αおよびPGE1類縁物質、ミソプロストールのような天然および合成プロスタグランジンのような体液薬;
35. アトロピン、メタンテリン、パパベリン、シンナメドリン、メトスコポラミンなどのような鎮痙薬;
37. インスリンのような抗糖尿病薬、およびタモキシフェン、メトトレキサートなどのような抗癌剤;
38. デクストロアンフェタミン、メタアンフェタミン、フェニルプロパノールアミン、フェンフルラミン、ジエチルプロピオン、マジンドール、フェンテルミンなどのような食欲抑制薬;
40. フェニルエフリン、エフェドリン、ナファゾリン、テトラヒドロゾリンなどのようなうっ血除去薬;
41. アスピリン、サリチルアミドなどの解熱剤;
42. ジヒドロエルゴタミン、ピゾチリンなどのような抗偏頭痛剤;
44. ミソプロストール、オメプラゾール、エンプロスチルなどのような抗潰瘍剤;
45. 成長放出因子(growth releasing factor)などのペプチド;
46. タモキシフェンまたはヒト絨毛性性腺刺激ホルモンなどの抗エストロゲンまたは抗ホルモン剤;
47. アラントイン、アルジオキサ、アルコキサ、N-メチルスコポラミンメチルサルフレートなどの抗潰瘍剤;
48. 抗糖尿病剤など。
メトロニダゾールを含む抗細菌剤
抗生物質および他の抗細菌剤は、しばしばグループにクラス分けされ、そして議論される、非常に種々のクラスの化合物である。それらは、作用の様式または抗菌活性スペクトルによりクラス分けされ得るが、一般的に、同じような構造を有するものは、一緒に分類される。
アミカシン、アプラマイシン、アルベカシン、アストロミシン、ベカナマイシン、ジベカシン、ジヒドロストレプトマイシン、フラマイセチン、ゲンタミシン、イセパミシン、カナマイシン、ミクロノミシン、ネオマイシン、ネチリミシン、シソミシン、ソトレプトマイシン、トブラマイシン。
アミノサリチル酸、カプレオマイシン、クロファジミン、シクロセリン、ダプソン、エタムブトール、エチオナミド、イソニアジド、メタニアジド、モリナミド、プロチオナミド、ピラジナミド、リファブチン、リファムピシン、リファマイシン、リファペンチン、リファキシミン、チオアセタゾン。
薬物グループ:セファロスポリン、関連βラクタムまたはセフェム抗生物質
アズトレオナム、ベタミプロン、ビオペネム、カルモナム、セファクロール、セファドロキシル、セファレキシン、セファロニウム、セファロリジン、セファロチン、セファマンドール、セファゾリン、セファピリン、セファトリジン、セフカペネ、セフジニル、セフジトレン、セフェパイム、セフェタメト、セフィキシム、セフルプレナム、セフメノキシム、セフメタゾール、セフミノクス、セフォジザイム、セフォニシド、セフォペラゾン、セフォラニド、セフォセリス、セフォタキシム、セフォテタン、ソフォチアム、セフォキシチン、セフォゾプラン、セフピラミド、セフピロム、セフポドキシム、セフプロジル、セフキノム、セフスロジン、セフタジダイム、セフテラム、セフテゾール、ソフチブテン、セフチオフル、セフチゾシキム、セフトリアキソン、セフロキシム、セフラジン、シラスタチン、ファロペネム、フロモキセフ、イミペネム、ラトモキセフ、ロラカルベフ、メロペネム、パニペネム。
アジダムフェニコール、クロラムフェニコール、フロルフェニコール、チアムフェニコール、
アボパルシン、ラモプラニン、テイコプラニン、バンコマイシン、
リンコサミド類
クリンダマイシン、リンコマイシン、ピルリマイシン、
アジスロマイシン、クラリスロマイシン、ジリスロマイシン、エリスロマイシン、フルリスロマイシン、ジョサマイシン、キタサマイシン、ミデカマイシン、オレアンドマイシン、プリスチナマイシン、キヌプリスチン/ダルフォプリスチン、ロキタマイシン、ロキシスロマイシン、スピラマイシン、チルミコシン、トロレアンドマイシン、チロシン、バージニアマイシン、
βラクタマーゼ阻害剤 クラブラン酸、スルバクタム、およびタゾバクタムが、ある一定のβラクタム抗生物質の抗菌範囲を拡張するために用いられる。
アモキシシリン、アンピシリン、アスポキシシリン、アジドシリン、バカムピシリン、ベネタミン、ペニシリン、ベンザチン ベンジルペニシリン、ベンザチン フェノキシメチルペニシリン、ベンジルペニシリン、カルベニシリン、カルフェシリン、カリンダシリン、シクラシリン、クラブラン酸、クレミゾール ペニシリン、クロメトシリン、クロキサシリン、ジクロキサシリン、フルクロキサシリン、メシリナム、メタムピシリン、メチシリン、メゾロシリン、ナフシリン、オキサシリン、ペネタマート、ペネチシリン、フェノキシメチルペニシリン、ピペラシリン、ピバムピシリン、ピバメシリナム、プロカイン ペニシリン[プロカイン ベンジルペニシリン]、プロピシリン、スルバクタム、スルベニシリン、スルタミシリン、タゾバクタム、テモシリン、チカルシリン、
アクロソキサシン[ロソキサシン]、アラトロフロキサシン、バロフロキサシン、シノキサシン、シプロフロキサシン、クリナフロキサシン、ダノフロキサシン、ジフロキサシン、エノキサシン、エンロフロキサシン、フレロキサシン、フルメキン、ガチフロキサシン ゲミフロキサシン、グレパフロキサシン、レバフロキサシン、ロメフロキサシン、マルボフロキサシン、モキシフロキサシン、ナジフロキサシン、ナリジキシ酸、ノルフロキサシン、オフロキサシン、オルビフロキサシン、オキソリン酸、ペフロキサシン、ピペミド酸、ピロミド酸、プルリフロキサシン、ルフロキサシン、サラフロキサシン、スパルフロキサシン、テマフロキサシン、トスフロキサシン、トロバフロキサシン、
バキロプリム、ブロジモプリム、カルシウム スルフォロキサート、コ-テトロキサジン、コ-トリファモール、コ-トリマジン、コ-トリマキサゾール、フォルモスルファチアゾールメフェニド、オルメトプリム、フタリルスファチアソール、シクシニルスフルファチアゾール、スルファベンザミド、スルファクロジン、スルファクリソイジン、スルファジクラミド、スルファドキシン、スルファメラジン、スルファメチルチアゾール、スルファメトピラジン、スルファメトロール、スルファモノメトキシン、スルファキノキサリン、スルファスクシンアミド、スルファトロキサゾール、スルファセタミド、スルファクロルピリダジン、スルファジアジン、スルファジアジン シルバー、スルファジメトキシン、スルファジミジン、スルファフラゾール、スルファグアジジン、スルファメチゾール、スルファメトキサゾール、スルファメトキシピリダジン、スルファムオキソール、スルファニラミド、スルファピリジン、スルフィソミジン、スルファチアゾール、スルファカルバミド、テトロキソプリム、トリメトプリム、
クロルテトラサイクリン、デメクロサイクリン、ドキシサイクリン、リメサイクリン、メクロサイクリン、メタサイクリン、ミノサイクリン、オキシテトラサイクリン、ロリテラサイクリン、テトラサイクリン、
アセジアスロホン、アルサニル酸、アビラマイシン、バシトラシン、バムベルマイシン、カルボドックス、フラルタドン、フサフンギン、フシジン酸、グラミジジン、ハルキノール、メテナミン、リネゾリド、マガイニンス、マンデル酸、ムピロシン、ニフロキサジン、ニフルトイノール、ニフルジド、ニシン、ニトロフラントイン、ニトロフラゾン、ニトロキソリン、ノボビオシン、ポリミシンB、スペクチノマイシン、スルファマゾン、タウロリジン、テリスロマイシン、テリジドン、セノイック酸(Thenoic acid)、チオストレプトン、チアムリン、トロソペクトマイシン、チロスリシン、バルネムリン、キシボルノール、
アルベンダゾール、ジエチルカルバマジン、イベルメクチン、レバミゾール、メベンダゾール、ニクロサミド、オキサムニキン、ピペラジン、プラジクアンテル、ピランテル、チアベンダゾール。
シンコナアルカロイドおよびメフロキン4-メタノールキノリン誘導体。クロロキン、ヒドロキシクロロキンおよびアモジアキンのような4-アミノキノリン類。プリマキンおよびタフェノキンのような8-アミノキノリン類。プログアニルおよびクロルプログアニルのようなビグアナイド類。ピリメタミンのようなジアミノピリミジン類。ジクロロベンジリデン ルメファントリン。アトバキノンのようなヒドロキシナフトキノン類。ハロフェントリンのような9-フェナンスレンメタノール類。アルテミシニンおよびその誘導体のようなセスキテルペン類。スルホンアミド類 スルファドキシンおよびスルファメトピラジン。ドキシサイクリンおよびテトラサイクリンのようなテトラサイクリン類。リンコサミド、クリンダマイシン。ダプソンのようなスルホン類。
メグルミンアンチモネートおよびナトリウムスチボグルコネートを含むアンチモン化合物、ペンタミジンを含む芳香族ジアミン類、5価の化合物 アセタルソールおよびトリパルアミド、ならびに3価であるメラルソプロールを含むヒ素剤、ジロキサニドを含むジクロロアセタミド類、ジアイオドヒドロキシキノリンを含むハロゲン化ヒドロキシキノリン類、フラゾリドン、ニフラテルおよびニフルチモックスを含むニトロフラン類、ならびにメトロニダゾール、ニモラゾール、オルニダゾール、セクニダゾールおよびチニダゾールを含む5-ニトロイミダゾール類。アトバキオン、ベンズニダゾール、デヒドロエメチン、エフロルニシン、メパクリンおよびスラミンを含む他の薬物。
抗喘息薬グループ
抗ムスカリン剤およびβアゴニスト
例えば、イプラトロピウムブロミドおよびオキシトロピウムブロミドのような4級アンモニウム化合物、サルメテロール、アルブテロール、ビトルテロール、イソエタリン、メタプロテレノール、ピルブテロール、テルブタリン、イソプロテレノール、エフェドリン、エフェドリン サルブタモール。
ベクロメタゾン ジプロピオネート、ブデソニド ツルブハレル、フルニソリド、フルチコゾン、トリアムシノロン アセトニド。
ロイコトリエン阻害剤およびアンタゴニスト
ザフィルルカスト、モンテルカスト。
ナトリウム クロモグリケートおよびネドクロミル ナトリウム。
キサンチン類
テオフィリンおよびその誘導体。
抗真菌剤
フルシトシン、グリセオフルビン、ケトコナゾール、ミコナゾール。
本発明の医薬組成物は、少なくとも
1) 粒状物質として一以上の活性物質。純粋な物質(結晶または非晶質、粉末の形態)としてか、コーティングによりカプセル化されるか、マトリックス中に閉じ込められるか、またはイオン交換樹脂に結合されるかのいずれかで、
2) 一以上の膨張化/ゲル化物質、および任意に、
3) 甘味剤
4) 芳香剤
5) 着色剤
をブレンドすることにより製造され得る。
この方法は、新規な投与形態として得られる粉末/粒状物質が、いかなる剪断力も用いないで、所望の時間以内に、プリン様の塊に変換されることに寄与する。この特徴は、例えば、スプーン上または撹拌もしくは機械的混合中に撹拌子上に、活性物質がロスされることの危険性がないので、非常に少量の活性物質に対しても、この新規な投与形態を用いることが可能であることで、非常に有利である。発明者の知る限りでは、この点で、これは、錠剤またはカプセル剤形に匹する、最初の半液体代替物である。
i) 本質的にジェランガムの溶解性より実質的に低い溶解性を有する、一以上の賦形剤および/または活性成分を含まない、ジェランガムを含む第一のブレンドを顆粒化すること、
ii) ジェランガムの溶解性より実質的に低い溶解性を有する、一以上の賦形剤および/または活性成分を、顆粒化された第一のブレンドに加えること
を含む。
図1は、(A)スプーンに付着する「剥離」フィルムで覆われた乾燥組成物を有するスプーン、(B)においてフィルムが除去され、(C)水が加えられ、(D)そこでゲル化が起こり、(E)これが逆さに傾けられたときスプーンを滑り落ちない物質の膨張が起こることを示す。
図3は、水の摂取後でかつ実施例19による製剤の摂取前に、インビボで超音波測定により記録された胃を示す。
図5は、実施例19による製剤および図4に示されたものの完全な分散を示す。
図7は、物質の完全な崩壊を示す、pH4.8での溶剤中での図6と同様の溶解を示す。
図9は、異なるpH値で、パラセタモールの速い溶解速度をもたらす、実施例24による製剤の溶解を示す。同様の効果が、擬胃液中でも得られる。
以下の実施例のいくつかは、活性成分が加えられる異なった組成物を示すために、活性成分を用いないで作られ用いられた(すなわち、それらは媒体である)。これらの製剤のいくつかは、消費者試験用として用いられた。ここで用いられるように、パーブレット(Parvulet)の用語は、本発明による、あらゆる製剤を表わし、本製品の商標である。
99.9% 無水アルコール、De danske spritfabrikker、医薬クレード
エアロジル(Aerosil)、Unikem、医薬グレード
カラメル臭、Frutarom
セフィキシム アキセチル、Stragen Nordic
チョコレート臭、Kiranto food
コーティングされたフマル酸第1鉄、医薬グレード
ゲラン(Gellan)、ケルコゲルLT100、CpKelco ApS、医薬グレード
ゲラン、ケルコゲルF、CpKelco ApS、医薬グレード
グリセロール、Uniqema、医薬グレード
コーティングされたイブプロフェン、Nycomed DK、医薬グレード
インスタントシュガー(Instant sugar)、Danisco Oy、医薬グレード
インスリン インスタント(Inulin instant)、Fibruline
イスパギュラエ ハンスク(Ispaghulae Husks)、ヴィ-シブリン(Vi-siblin)、Pfizer
トウモロコシデンプン ウルトラスプレッセ(Ultrasprese) HV、National Starch & Chemical
中鎖トリグルセリドEP (Labrafac cc), Gattefosse SAS, 医薬グレード
PVP (プラストドン(plastdone)(登録商標) K-25、ISP (スイス) AG
コーティングされたピリドキシン、Ferrosan、医薬グレード
クエン酸ナトリウム、Unikem、医薬グレード
炭酸水素ナトリウム、Unikem、医薬グレード
ナトリウムデンプングリコレート、Explotab、JRS Pharma
イチゴ臭、Kiranto food
トゥッティ・フルッティ臭、Frutarom
バニラ臭、Keranto food A/S
キサンタンガム、Keltrol CpKelco ApS, 医薬グレード
キシリトール、Danisco Sweeteners LtD
エウドラギット(Eudragite) EPO、Rohm
ラウリルサルフェート、Sigma
アルタルク(Altalc) 500V、Luzenac America
エウドラギット(Eudragite) NE30D、Rohm
均質でわずかに粘着性の比較的小さな粒子が存在するまで、手練りが行なわれた。好適な装置は、Zanchetta Roto P100 - 100リッター容量またはMTI混合機のような高剪断(High Shear)混合機を含む。
落下試験器具は、2.5および5 ml液体に対する表示を有する、Nomeco (DBIプラスチックタイプ 115022)から入手した医薬用プラスチックスプーンであり、図1の、例えば図Eを参照。
試験スプーン中に、試験物質0.5 g〜0.7 gを正確に秤量する。水道水3 ml〜5 mlを加える。1/2分待って、スプーンを回転し、もし試験物質が落下(剥落)しなければ、その物質は試験をパスした。
装置
ブルックフィールド粘度計 モデルLVF、Serie 56779
スピンドルNo. #4 直径3.2 mm、長さ33.96 mm
500 mlビーカー 低フォーム(low form)(内径約90 mm)
温度計
速度:6 rpm
スピンドル: 粘度計スピンドルが、試験試料容器中の中心に置かれる。スピンドルは、シャフトの狭い部分の中点まで、適当に浸される。
ビーカー500 ml中に、試験物質22〜88 gを正確に秤量し、水道水500 mlを加える。物質全てが分散/溶解するまで混合し、約5分後に、粘度と温度を測定する。
製剤に水道水を加え、液体全てを吸収するとき(目視で確認)、試験を開始できる。その製剤の味を見て、10が最も快適な味である、1〜10の味覚にテンク付けする。
コーティングされたセフキシム単位用量250mgを含む、本発明による組成物
活性物質としてセフキシムを含む、図1に示されたような形状を有する組成物を次のようにして製造した。
エクスプロタブ(Explotab) 46.31 0.97
インスタント糖 46.32 0.97
エアロジル 0.53 0.011
バニラ臭 4.64 0.096
グリセロール 2.35(結合剤) 0.048
ブレンド1 60 2.1
コーティングされたセフキシム 40 1.4
この実施例において、エクスプロタブは、グリセロールと一緒に顆粒化されるゲル化剤として用いられる。
上記の投与形態に、水道水4 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたセフキシム単位用量250mgを含む、本発明による組成物
活性物質としてセフキシムを含む、図1に示されたような形状を有する組成物を次のようにして製造した(重量%として与えられる)。
エクスプロタブ(Explotab) 46.31 0.87
インスタント糖 46.32 0.87
エアロジル 0.53 0.094
バニラ臭 4.64 0.086
グリセロール 2.35 0.043
ブレンド1 53.6 1.87
コーティングされたセフキシム 35.7 1.25
ヴィ-シブリン 10.7 0.38
上記の投与形態に、水道水4 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたセフキシム単位用量250mgを含む、本発明による組成物
活性物質としてセフキシムを含む、図1に示されたような形状を有する組成物を次のようにして製造した(重量%として与えられる)。
ケルコゲルLT100 23.11 0.52
キシリトール 69.12 1.55
エアロジル 0.53 0.011
バニラ臭 54 0.112
グリセロール 2.35
ブレンド1 64.3 2.25
コーティングされたセフキシム 35.7 1.24
上記の投与形態に、水道水4 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたピリドキシン単位用量150mgを含む、本発明による組成物
活性物質としてコーティングされたピリドキシンを含む、図1に示されたような形状を有する組成物を次のようにして製造した。
ケルコゲルLT100 501 0.938
キシリトール 47.52 0.89
バニラ臭 2.53 0.047
ブレンド1 75 1.875
コーティングされたピリドキシン 25 0.625
ブレンド2 71.41 2.50
ケルコゲルF 14.32 0.5
水 14.33 0.5
ブレンド3からの成分(2〜3(結合化溶液))を1/2 分混合し、そのブレンドに、成分1を加え、約1/2 分(粉末量に依存)混合し、顆粒を形成する。
上記の投与形態に、水道水3 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたフマル酸第1鉄単位用量150mgを含む、本発明による組成物
活性物質としてコーティングされたフマル酸第1鉄を含む、図1に示されたような形状を有する組成物を次のようにして製造した。
ケルコゲルLT100 501 0.938
キシリトール 47.52 0.89
バニラ臭 2.53 0.047
ブレンド1 75 1.875
フマル酸第1鉄 25 0.625
ブレンド2 71.41 2.50
ケルコゲルF 14.32 0.5
水 14.33 0.5
ブレンド3からの成分(2〜3)を1/2 分混合し、そのブレンドに成分1を加え、約1/2 分(粉末量に依存)混合する。
上記の投与形態に、水道水3 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたイブプロフェン単位用量125mgを含む、本発明による組成物
活性物質としてコーティングされたイブプロフェンを含む、図1に示されたような形状を有する組成物を次のようにして製造した。
ケルコゲルLT100 52.61 0.87
キシリトール 47.42 0.79
ブレンド1 64.1 1.66
イブプロフェン 20.9 0.54
バニラ臭 15 0.39
ブレンド2 74.21 2.59
ケルコゲルF 12.92 0.45
水 12.93 0.45
ブレンド3からの成分(2〜3)を1/2 分混合し、そのブレンドに成分1を加え、約1/2 分(粉末量に依存)混合する。
上記の投与形態に、水道水3 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたイブプロフェン単位用量125mgを含む、本発明による組成物
活性物質としてコーティングされたイブプロフェンを含む、図1に示されたような形状を有する組成物を次のようにして製造した。
ケルコゲルLT100 52.61 0.95
キシリトール 47.42 0.86
ブレンド1 69.7 1.81
コーティングされたイブプロフェン 22.7 0.58
トゥッティフルッティ臭 7.6 0.20
ブレンド2 74.21 2.59
ケルコゲルF 12.92 0.45
水 12.93 0.45
ブレンド3からの成分(2〜3)を1/2 分混合し、そのブレンドに成分1を加え、約1/2 分(粉末量に依存)混合する。
上記の投与形態に、水道水3 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたイブプロフェン単位用量125mgを含む、本発明による組成物
活性物質としてコーティングされたイブプロフェンを含む、図1に示されたような形状を有する組成物を次のようにして製造した。
ケルコゲルLT100 52.61
キシリトール 47.42
ブレンド1 71 1.83
コーティングされたイブプロフェン 23.2 0.6
カラメル臭 5.8 0.15
ブレンド2 74.21 2.59
ケルコゲルF 12.92 0.45
水 12.93 0.45
ブレンド3からの成分(2〜3)を1/2 分混合し、そのブレンドに成分1を加え、約1/2 分(粉末量に依存)混合する。
上記の投与形態に、水道水3 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。秒当たりのg用量に対するg水吸収で測定される、秒当たりの用量に対する平均水吸収速度は、0.1739 g/g/秒の水吸収速度に相当する3 g/.575 g/30秒である。
コーティングされたフマル酸第1鉄単位用量125mgを含む、本発明による組成物
活性物質としてコーティングされたフマル酸第1鉄を含む、図1に示されたような形状を有する組成物を次のようにして製造した。
ケルコゲルLT100 50.61 0.91
キシリトール 47.42 0.83
ブレンド1 67.2 1.74
コーティングされたフマル酸第1鉄 25.9 0.56
チョコレート臭 10.9 0.29
ブレンド2 74.21 2.59
ケルコゲルF 12.92 0.45
水 12.93 0.45
ブレンド3からの成分(2〜3)を1/2 分混合し、そのブレンドに成分1を加え、約1/2 分(粉末量に依存)混合する。
上記の投与形態に、水道水3 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
本発明によるプラセボ組成物
図1に示されたような形状の組成物を、次のようにして製造した。
ケルコゲルLT100 22.51 0.675
キシリトール 67.52 2.025
ウルトラスペルセ(Ultrasperse)HV 10.03 0.3
ブレンド1 94.0 3.0
イチゴ臭 6.0 0.2
ブレンド2 91.41 3.20
クエン酸ナトリウム 1.22 0.042
水 8.43 0.294
ブレンド3からの成分(2〜3)を1/2 分混合し、そのブレンドに成分1を加え、約1/2 分(粉末量に依存)混合する。
上記の投与形態に、水道水3.5 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
本発明によるプラセボ組成物
図1に示されたような形状の組成物を、次のようにして製造した。
ケルコゲルLT100 251 0.65
キシリトール 752 1.94
ブレンド1 80.3 2.59
イヌリン 13.1 0.42
カラメル臭 6.6 0.21
ブレンド2 92 3.22
水 8 0.28
ブレンド3を1/2 分(粉末量に依存)混合する。
上記の投与形態に、水道水3.5 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
本発明によるプラセボ組成物
図1に示されたような形状の組成物を、次のようにして製造した。
ケルコゲルLT100 501 1.2
キシリトール 502 1.2
ブレンド1 80 2.4
ケルトロール(Keltrol) 20 0.6
ブレンド2 71.41 3.0
カラメル臭 14.32 0.5
水 14.33 0.5
ブレンド3からの成分(2〜3)を1/2 分(粉末量に依存)混合し、そのブレンドに、成分1を加え、約1/2 分(粉末量に依存)混合する。
上記の投与形態に、水道水3 mlを加える。約1/2 分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたセフキシム単位用量120 mgを含む、本発明による組成物
活性物質としてセフキシムを含む、図1に示されたような形状を有する百分率での組成物を次のようにして製造した。
クエン酸ナトリウム 251 0.157
デム(Dem.)水 752 0.470
ブレンド1 98.041 1.74
ケトロール 1.962 0.013
ブレンド2 60 0.642
マイクロカプセル化セフキシム 40 0.42
ケルコゲルLT100 501 0.98
キシリトール 502 0.98
ブレンド4 56.1 1.96
ブレンド3 30.3 1.06
ケトロール 9.1 0.32
リンゴ果実 4.5 0.16
ブレンド4からの成分を、乳鉢中、スクレーパまたはカードを用いて、全てがブレンドされるまで混合する。
上記の投与形態に、水道水(15〜20℃の温度)4 mlを加える。約15秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたセフキシム単位用量120 mgを含む、本発明による組成物
活性物質としてセフキシムを含む、図1に示されたような形状を有する百分率での組成物を次のようにして製造した。
ケルコゲルLT100 40 1.195
キシリトール 40 1.196
ケトロール 20 0.60
酒石酸ナトリウム 251 1.74
デム(Dem.)水 733 0.372
ケトロール 22 0.011
ブレンド1 85.4 2.99
ブレンド2 14.6 0.51
上記の投与形態に、水道水(15〜20℃の温度)4 mlを加える。約15秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
500 mlのビーカー中に、正確に秤量した試験化合物43.75 gを移し、水道水500 mlで分散/溶解する。
粘度を60500 cpsまで測定する。
コーティングされたパラセタモール単位用量50 mgを含む、本発明による組成物
活性物質としてパラセタモールを含む、図1に示されたような形状を有する百分率での組成物を次のようにして製造した。
酒石酸ナトリウム 25
デム(Dem.)水 75
ケルコゲルLT100 50
キシリトール 50
ブレンド2 75
ケトロール 12.5
リンゴ果実 12.5
ブレンド3 74.22
ブレンド1 12.13
マイクロカプセル化パラセタモール 13.65(純粋なパラセタモール61%)
ブレンド4からの成分を、乳鉢中、スクレーパまたはカードを用いて、均質のブレンドが得られるまで混合する。
上記の投与形態に、水道水(15〜20℃の温度)4 mlを加える。約15秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたパラセタモール単位用量50 mgを含む、本発明による組成物
活性物質としてパラセタモールを含む、図1に示されたような形状を有する百分率での組成物を次のようにして製造した。
酒石酸ナトリウム 25
デム(Dem.)水 75
ブレンド1 50
クエン酸ナトリウム 11
PEG200 39
ケルコゲルLT100 42.86
キシリトール 42.86
ケトロール 14.28
ブレンド2 80.50
ブレンド3 19.50
ブレンド4 91.00
マイクロカプセル化パラセタモール 10.00(純粋なパラセタモール61%)
PVP(コリドン(kollidon)25k) 9.52
99.9% エタノール 85.72
グリセロール 4.76
ブレンド5を820 mg /用量に分ける。その用量を、調製された医療用スプーン中に計り分け、ストッパーで、顆粒をスプーンに軽く押し付けることにより、スプーンの底に、高さ約1〜3 mmの薄層を形成する。水を室温で蒸発する。
上記の投与形態に、水道水(15〜20℃の温度)4 mlを加える。約15秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたパラセタモール単位用量200 mgを含む、本発明による組成物
活性成分としてパラセタモールを含む、図1に示されたような形状を有する、百分率での組成物を次のようにして製造した。
ゲランガム(ケルコゲルLT100) 50.00
キシリトール 50.00
ブレンド1 37.5
マイクロカプセル化パラセタモール 52(純粋なパラセタモール61%)
グリセリン 10.5
ポビドン(コリドン25k) 9.52
99.9% エタノール 85.72
グリセロール 4.76
調製されたスプーン:スプーンの窪んだ側を、ブレンド4で2回スプレーする。エタノールを45℃で1時間、オーブン中で蒸発する。
上記の投与形態に、水道水(15〜20℃の温度)4 mlを加える。約15秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
物質および方法
擬胃液: 1Lに対して; 0.1H HCl
溶解システムは、Disslabバージョン1.1を用いる、オンラインシステムモデルSOTAX AT7およびUV検出機モデルPEラムダ2よりなる。
溶解曲線は、温度37℃、速度120rpm、280nmおよび1時間以上で108の因子(factor)を用いて得られた。
図2は、擬胃液中のパラセタモール単位用量の溶解度プロファイルを示す。5分後に、パラセタモールの少なくとも96%が放出される。
点−線を有する曲線が、本投与形態に用いられた純粋なコーティングされたパラセタモールであり、5分後に、パラセタモールの少なくとも96%が放出される。
純粋なコーティングされたパラセタモールと本パラセタモール単位用量とを比較して、放出プロファイルに差は見られない。
コーティングされたパラセタモール単位用量250 mgを含む、本発明による組成物
活性物質としてパラセタモールを含む、図1に示されたような形状を有する、百分率での組成物を次のようにして製造した。
クエン酸ナトリウム 25
脱イオン水 75
ゲランガム(ケルコゲルLT100) 50.00
キシリトール 50.00
ブレンド1 42.7
ブレンド2 9.8
マイクロカプセル化パラセタモール 38.7 (純粋なパラセタモール61%)
炭酸水素ナトリウム 2.9
イチゴ臭 5.8
ブレンド2:ブレンドからの成分を、乳鉢中、乳棒を用いて、必要なら削り取り、均質なブレンドまで混合する。
ブレンド3:ブレンドからの成分を、乳鉢中、乳棒を用いて、必要なら削り取り、均質なブレンドまで混合する。
ポビドン(コリドン25k) 9.52
99.9% エタノール 85.72
グリセロール 4.76
調製されたスプーン:スプーンの窪んだ側を、ブレンド4で2回スプレーする。エタノールを45℃で1時間、オーブン中で蒸発する。
上記の投与形態に、水道水(15〜20℃の温度)4 mlを加える。約15秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
本発明によるプラセボ組成物
図1に示された形状を有する組成物を、次のようにして製造した(重量%として与えられる)。
クエン酸ナトリウム 25
脱イオン水 75
ケルコゲルLT100 50
キシリトール 50
ブレンド1 11.2
ブレンド2 80
炭酸水素ナトリウム 3
イチゴ臭/バナナ臭 5.8
ブレンド2:ブレンドからの成分を、乳鉢中、乳棒を用いて、必要なら削り取り、均質なブレンドまで混合する。
ブレンド3:ブレンドからの成分を、乳鉢中、乳棒を用いて、必要なら削り取り、均質なブレンドまで混合する。
上記の投与形態に、水道水3 mlを加える。約1/2分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
上記のプラセボ製剤のインビボでの性質が、8〜12時間絶食した被験者で、水250 mLの摂取前および製造された本投与形態の摂取5分後に測定された。超音波撮像が、操作の間ずっと、座位で行なわれた。
図4は、摂取された財形が、超音波画像で「白く」表示されることを示す。
本発明による使用のためのプラセボ組成物
図1に示された形状を有する組成物を、次のようにして製造した(重量%として与えられる)。
ケルコゲルLT100 50
キシリトール 50
ブレンド1 92.4
ポビドン(コリドン25k) 0.5
イチゴ臭/バナナ/バニラ臭 7.1
ブレンド1 93.8
99.9% エタノール 6.2
ブレンド2:ブレンド2からの成分を、乳鉢中、乳棒を用いて、必要なら削り取り、均質なブレンドまで混合する。
ブレンド3:ブレンド3からの成分を、乳鉢中、乳棒を用いて、必要なら削り取り、均質なブレンドまで混合する。
ポビドン(コリドン25k) 9.52
99.9% エタノール 85.72
グリセロール 4.76
調製されたスプーン:スプーンの窪んだ側を、ブレンド4で2回スプレーする。エタノールをオーブン中、1時間、45℃で蒸発する。
上記の投与形態に、水道水3 mlを加える。約1/2分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
本発明による使用のためのプラセボ組成物
図1に示された形状を有する組成物を、次のようにして製造した(重量%として与えられる)。
ケルコゲルLT100 50
キシリトール 50
ブレンド1 83.3
中鎖トリグリセリドEP
(Labrafac cc) 5.6
ポビドン(コリドン25k) 5.6
バニラ臭 5.6
ブレンド2:ブレンド1を中鎖トリグリセリドEP(Labrafac cc)と、乳鉢中、乳棒を用いて、必要なら削り取り、均質なブレンドまで混合し、そして、均質なブレンドにポビドン(コリドン25k)を添加混合し、その混合物に、バニラ臭を加え、均質な塊(mass)にブレンドする。
ポビドン(コリドン25k) 9.52
99.9% エタノール 85.72
グリセロール 4.76
調製されたスプーン:スプーンの窪んだ側を、ブレンド3で2回スプレーする。エタノールをオーブン中、1時間、45℃で蒸発する。
上記の投与形態に、水道水3 mlを加える。約1/2分後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
予備水和を有するか、または有しない口腔での直接使用のための口腔衛生組成物
図1に示されたような形状を有する、百分率での組成物を次のようにして製造した。
キシリトール 86.6
グリセロール 13.4
ケルコゲルLT100 46.4
本発明によるプラセボ組成物
図1に示されたような形状を有する組成物を、次のようにして製造した。
ケルコゲルLT100 50 18.78
キシリトール 50 18.78
バニラ臭 92.2 2.25
PVP K25 7.8 0.19
ブレンド1 88.89 37.56
ブレンド2 5.78 2.44
グリセロール 5.33 2.25
PVP K25 9.5 4.00
グリセロール 4.8 2.00
99.9%エタノール 85.7 36.01
ブレンド2:バニラ臭を乳鉢中ですりつぶし、PVP K25を撹拌下に徐々に加え、均質なブレンドを形成する。
医療用スプーン:医療用スプーンの窪んだ側を、ブレンド4(約60 mg)で2回スプレーし、30分間、45℃でオーブン中に置く。
上記の投与形態に、水道水5 mlを加える。約30秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
パラセタモール250 mgを含む、本発明による組成物
図1に示されたような形状を有する組成物を、次のようにして製造した。
ケルコゲルLT100 50 18.78
キシリトール 50 18.78
バニラ臭 92.2 2.25
PVP K25 7.8 0.19
ブレンド1 42.8 6.24
ブレンド2 2.76 0.402
グリセロール 3.42 0.499
パラセタモール 40.6 5.92
グリセロール 10.5 1.53
PVP K25 9.5 4.00
グリセロール 4.8 2.00
99.9%エタノール 85.7 36.01
ブレンド2:バニラ臭を乳鉢中ですりつぶし、PVP K25を混合下に徐々に加え、均質なブレンドを形成する。
医療用スプーン:医療用スプーンの窪んだ側を、ブレンド4(約60 mg)で2回スプレーし、30分間、45℃でオーブン中に置く。
上記の投与形態に、水道水5 mlを加える。約30秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
コーティングされたパラセタモール415 mg(パラセタモール250 mgに相当)を含む、本発明による組成物
図1に示されたような形状を有する組成物を、次のようにして製造した。
ケルコゲルLT100 50 18.78
キシリトール 50 18.78
バニラ臭 92.2 2.25
PVP K25 7.8 0.19
ブレンド1 33.2 10.5
ブレンド2 2.15 0.678
グリセロール 2.66 0.840
コーティングされたパラセタモール 57.1 18.06
グリセロール 4.81 1.52
PVP K25 9.5 4.00
グリセロール 4.8 2.00
99.9%エタノール 85.7 36.01
ブレンド2:バニラ臭を乳鉢ですりつぶし、混合下に、PVP K25を徐々に加え、均質なブレンドを形成する。
医療用スプーン:医療用スプーンの窪んだ側を、ブレンド4(約60 mg)で2回スプレーし、30分間、45℃でオーブン中に置く。
上記の投与形態に、水道水5 mlを加える。約30秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
溶解のために、上記のようにして調製されたスプーンが、柄の除去後および窪んだ底の外側にくっ付けられた重りを伴い、溶解溶剤中に置かれた。これにより、スプーンは、溶剤900 mlを含む、50 rpmで回転するパドルが設置された各溶解容器の底に置かれた。
0.1 N HCl〜pH 1(試験溶剤1):容器5および6
5000 mlのブルーキャップフラスコに純水1000 mlを加える。
5000 mlのブルーキャップフラスコに37 重量% HCl 25.5 mlを注意深く加える。
3000 mlになるまで純水を加える。
その溶液のpHを測定する。
5000 mlのブルーキャップフラスコに、0.2 M KH2PO4 溶液(QCF026により調製)、750 mlを加える。
エリキシル水、2250 mlを加える。
その溶液のpHを測定する。試料の添加後、pHは4.8に変化した。
容器1〜6中に脱気した溶解溶剤、895 gを入れる。
容器1および2:ホスフェート緩衝液、pH 6.8
容器3および4:ホスフェート溶液、pH 4.5
容器5および6:0.1N HCl
標準容器に、希釈緩衝液200 mlを入れる。
スプーンユニットの外側の底におもりをつける。
試験ユニットに水道水(室温)4 mlを加える。
結果は、試験物質からのパラセタモールの速い溶解速度を示す。しかしながら、低pHでは、pH4.5および6.8に比較して、その放出は相対的により遅い。ゲル状ガムは、一度ゲル化すると溶解しないので、全ての溶解容器は、多量の非溶解物質を含むことに注意が必要である。溶剤のpHの違いに加えて、イオン組成における違いが、薬物放出に影響を及ぼし得る可能性があるので、それに注意すべきである。さらに、薬物放出は、pH 1および4.5で約91〜94 % ならびにpH 6.8で85〜87 % であることが注目される。この試験はn=2で行なわれたので、これが有意であるかどうかは決定することはできず、それはパラセタモールの特定のコーティング物に関するということは可能である。
同じような結果が、次の溶剤で得られた。
・ 25 Lのプラスチック容器に純水5000 mlを加える。
・ そのプラスチック容器に37重量% HCl、70 mlを注意深く加える。
・ NaCl 42.07 g ± 0.1 gを秤量し、それをそのプラスチック容器に加える。
・ その塩を溶解し、10000 mlになるまで純水を加える。
・ その溶液のpHを測定する。
コーティングされたイブプロフェン200 mgを含む、本発明による組成物
図1に示されたような形状を有する組成物を、次のようにして製造した。
ケルコゲルLT100 50 18.72
キシリトール 50 18.76
バニラ臭 92.2 2.24
PVP K25 7.8 0.19
ブレンド1 50.7 5.67
ブレンド2 3.29 0.33
グリセロール 6.00 0.60
コーティングされたイブプロフェン 40.0 4.00
PVP K25 9.5 4.00
グリセロール 4.8 2.00
99.9%エタノール 85.7 36.01
ブレンド2:バニラ臭を乳鉢中ですりつぶし、PVP K25を混合下に徐々に加え、均質なブレンドを形成する。
医療用スプーン:医療用スプーンの窪んだ側を、ブレンド4(約60 mg)で2回スプレーし、30分間、45℃でオーブン中に置く。
上記の投与形態に、水道水5 mlを加える。約30秒後、液体を吸収する。スプーンを回転し、2 分間、逆さまに保つ。試験物質が落ちず、試験をパスした。
ゲル化時間に関して、キシリトールと一緒に顆粒化されたゲランガムと効果的なゲル(混合物の300 mg)を得るために必要な水の量との効果的な比に関するガイドライン
キシリトールは粒状物の中への水の浸透を可能にし、ガムの速くかつ効果的な水和を保証する。用いられる結合剤は、製剤全体の7.0重量%のグリセロールである。顆粒化の方法は、実施例23のプラセボ製剤と同じである。表2に示されるように、50%/50%の混合物は、20%のキシリトールを含む混合物より加えられる水に対して感受性がより低いように、キシリトールは、ゲル化時間を減少させ、十分なゲル化を得るために必要な水の範囲を増加させる。明らかに、ゲランガムが少なければ、水は、製剤中の過剰な水の不都合な存在を避けるために、より少なく加えられるべきである。
Claims (36)
- 製剤が、
i) そのポリマー中、グルコース−ラムノース−グルコース−グルクロン酸単位の2回の繰返しごとに、4までの度合いでアシル化されたジェランガム、および
ii) ジェランガムの膨張を改善する、電解質、有機酸および浸透圧剤、およびそれらの混合物からなる群より選択される親水性剤
を含む微粒子の形態の媒体および一以上の活性物質を含む、経口投与用の微粒子の形態の製剤であって、
該製剤は、所定量の水性溶剤の添加により、剪断力または他の混合力を用いないで、5分以内に、膨張および/またはゲル化し、
ビーカー500 ml中に、試験物質22〜88 gを正確に秤量し、水道水500 mlを加えて、物質全てが分散/溶解するまで混合し、約5分後に、粘度と温度を測定する試験方法で、粘度計スピンドルが、試験サンプル容器の中心に置かれ、シャフトの狭い部分の中点まで、適当に浸された#4 LVスピンドルを有するブルックフィールド粘度計により、6rpmおよび20〜25℃で測定したときに、膨張した組成物が、少なくとも10,000 cpsの粘度を有し、
該製剤は、経口投与前に水性溶剤の添加により、半固体の形態に変化させることができる経口投与用の微粒子の形態の用時調製型製剤。 - 粘度が10,000〜99,000 cpsの範囲にある、請求項1に記載の製剤。
- アルギン酸、アルギン酸ナトリウム、アルギン酸カリウム、アルギン酸アンモニウム、アルギン酸カルシウム、プロパン-1,2-ジオール アルギネート、寒天、カラギーナン、加工ユーケマ藻類、ローカストビーンガム、グァーガム、トラガカント、アカシアゴム、キサンタンガム、カラヤガム、タラガム、コンニャク、ペクチン、メチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、エチルメチルセルロース、カルボキシメチルセルロース、カルボキシメチルセルロースナトリウム、架橋されたカルボキシメチルセルロースナトリウム、酵素的に加水分解されたカルボキシメチルセルロースを含むセルロース誘導体、ゼラチン、またはそれらの混合物を含む、親水コロイドおよびヒドロゲル化剤から選択される膨張および/またはゲル化剤をさらに含む、請求項1または2に記載の製剤。
- ジェランガムが25メッシュ〜300メッシュの平均粒径を有する、請求項1〜3のいずれか一つに記載の製剤。
- ジェランガムが、1回の繰返しにつき一つのグリセレートおよび2回の繰返しごとに一つのアセテートのアシル化の度合を有する、請求項1に記載の製剤。
- 前記の親水性剤が、親水性のビニルおよびアクリルポリマー、ポリサッカライド、PEO、PEG、PPG、ポリ(2-ヒドロキシエチルメタクリレート)、ポリ(アクリル)酸、ポリ(メタクリル)酸、PVP、PVA、PVA/PVPコポリマー、HEC、HPC、HPMC、CMC、CEC、アルギン酸ナトリウム、ポリカルボフィル、ゼラチンおよび澱粉グリコール酸ナトリウム、ならびにそれらの混合物からなる群より選択される浸透圧剤である、請求項1〜5のいずれか一つに記載の製剤。
- 前記の親水性剤が、PEO、PEG、PVP、HPMCおよびポリアクリル酸、ならびにそれらの混合物からなる群より選択される浸透圧剤である、請求項1〜6のいずれか一つに記載の製剤。
- 前記の親水性剤が、硫酸マグネシウム、塩化マグネシウム、塩化カルシウム、塩化ナトリウム、塩化リチウム、硫酸カリウム、炭酸ナトリウム、亜硫酸ナトリウム、硫酸リチウム、塩化カリウム、硫酸ナトリウム、マンニトール、キシリトール、尿素、ソルビトール、イノシトール、ラフィノース、ショ糖、グルコース、果糖、乳糖、イヌリン、インスタントシュガー、クエン酸、コハク酸、酒石酸、およびそれらの混合物よりなる群から選択される浸透圧剤である、請求項1〜7のいずれか一つに記載の製剤。
- 前記の親水性剤が、グルコース、乳糖、ショ糖、マンニトール、キシリトールおよび塩化ナトリウム、ならびにそれらの混合物よりなる群から選択される浸透圧剤である、請求項1〜8のいずれか一つに記載の製剤。
- 前記の親水性剤が、一価、二価または多価のイオン化可能な塩よりなる群から選択されるイオン化可能な物質または電解質である、請求項1〜5のいずれか一つに記載の製剤。
- 前記の塩が、種々のアルカリ金属および/またはアルカリ土類金属の硫酸塩、塩化物、ホウ酸塩、臭化物を含む無機塩、およびクエン酸塩、酢酸塩、乳酸塩を含むイオン化可能なアルカリ土類有機塩から選択される、請求項10に記載の製剤。
- 前記の塩が、硫酸カルシウム、塩化ナトリウム、硫酸カリウム、炭酸ナトリウム、塩化リチウム、リン酸三カリウム、ホウ酸ナトリウム、臭化カリウム、フッ化カリウム、重炭酸ナトリウム、塩化カルシウム、塩化マグネシウム、クエン酸ナトリウム、酢酸ナトリウム、乳酸カルシウム、硫酸マグネシウム、アルカリ金属塩化物、フッ化ナトリウム、クエン酸、コハク酸、フマル酸、リンゴ酸、マレイン酸、グルタル酸、乳酸を含む有機酸;および/または硫酸ナトリウムを含む硫酸アルカリ金属塩;二水素リン酸ナトリウム、一水素リン酸ナトリウム、リン酸水素二ナトリウム塩、およびそれらの混合物、ならびに多価金属カチオンから選択される、請求項11に記載の製剤。
- 前記の塩が、硫酸カルシウムまたは塩化ナトリウムである、請求項12に記載の製剤。
- 前記の親水性剤が、安息香酸、コハク酸、クエン酸およびアジピン酸ならびにその他の医薬的に認められた有機酸よりなる群から選択される有機酸である、請求項1〜5のいずれか一つに記載の製剤。
- 界面活性剤、着色剤、甘味剤、味マスキング剤、抗酸化剤、ポリサッカライド、糖、湿潤剤、UV吸収剤、懸濁化剤、安定化剤、可溶化剤、保存剤、加工助剤、pH調整剤、可塑剤、臭気マスキング剤、栄養剤、芳香剤、香気マスキング剤、乳化剤、増粘剤、分散剤、結晶成長抑制剤、結晶化促進剤、キレート化剤、緩衝剤、塩基および抗菌剤、ならびにそれらの混合物から選択される一以上の添加剤をさらに含む、請求項1〜14のいずれか一つに記載の製剤。
- グリセロールをさらに含む、請求項1〜15のいずれか一つに記載の製剤。
- 重炭酸ナトリウム、リン酸ナトリウム、水酸化ナトリウム、水酸化アンモニウム、スズ酸ナトリウム、トリエタノールアミン、クエン酸、塩酸、クエン酸ナトリウム、およびそれらの組合せを含む水性ゲルのpHを調整するのに適したいずれかの物質からなる群から選択されるpH調整剤を含む、請求項1〜16のいずれか一つに記載の製剤。
- pH調整剤が、0.05重量%〜5重量%を含む0.01重量%〜15重量%で存在する、請求項17に記載の製剤。
- 医薬的に許容されるアニオン性界面活性剤、カチオン性界面活性剤、両性(両親媒性/両性親和性)界面活性剤、およびポロキサマー、PEGおよびPEOを含む非イオン性界面活性剤;メチル硫酸ナトリウム、ラウリル硫酸ナトリウム、ならびに/またはジオクチルナトリウムスルホスクシネートからなる群から選択される湿潤剤を含む、請求項1〜18のいずれか一つに記載の製剤。
- 粉末ブレンドの形態にある、請求項1〜19のいずれか一つに記載の製剤。
- 顆粒、ビーズ、オブラートまたはペレットの形態にある、請求項1〜19のいずれか一つに記載の製剤。
- 顆粒状の形態にある、請求項1〜19のいずれか一つに記載の製剤。
- 活性物質が媒体との混合物中に存在する、請求項1に記載の製剤。
- 活性物質が媒体中に存在する、請求項1に記載の製剤。
- 活性物質が、コーティングおよび/またはマイクロカプセル化された形態で存在するか、またはマトリックス中に埋め込まれた、請求項1に記載の製剤。
- 試験スプーン中に試験物質0.5 g〜0.7 gを正確に秤量し、水道水3 ml〜5 mlを加え、1/2分待って、スプーンを逆さにし、もし試験物質が2分以内に落下(剥離)しなければ、その物質は試験にパスしたとする落下試験をパスする、請求項1〜25のいずれか一つに記載の製剤。
- 複数の粒子または複数のユニットの形態にある、請求項1〜26のいずれか一つに記載の製剤。
- 風味をマスキングするおよび/または制御された放出機能を有する成分を含む、請求項27に記載の製剤。
- 請求項1〜28のいずれか一つで定義されている製剤と合体した調剤ユニットを含むキット。
- 調剤ユニットがスプーンである、請求項29に記載のキット。
- 製剤が、調剤ユニットの表面に付着または接着された、請求項1〜28のいずれか一つに記載の製剤を含む調剤ユニット。
- くぼんだ表面を有する、請求項31に記載の調剤ユニット。
- スプーンの形態にある、請求項31または32に記載の調剤ユニット。
- 接着剤が、糖アルコール、糖、ポリビニルピロリドン(PVP)、ガムよりなる群から選択される、液体の形態または溶液である一以上の成分を含む、請求項31〜33のいずれか一つに記載の調剤ユニット。
- 接着剤がPVPとグリセロールとの混合物を含む、請求項31〜34のいずれか一つに記載の調剤ユニット。
- 乾燥成分をブレンドし、該混合物を任意に結合剤と顆粒化することを含む、請求項1〜28のいずれか一つに記載の製剤の製造方法。
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PCT/DK2005/000317 WO2005107713A2 (en) | 2004-05-11 | 2005-05-11 | Swellable dosage form comprising gellan gum |
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EP (2) | EP2258349B1 (ja) |
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AT (1) | ATE516019T1 (ja) |
CA (1) | CA2566793C (ja) |
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ES2517244T3 (es) | 2014-11-03 |
CA2566793C (en) | 2013-07-16 |
WO2005107713A2 (en) | 2005-11-17 |
DK1758557T3 (da) | 2011-10-24 |
EP2258349A3 (en) | 2012-04-04 |
US8383154B2 (en) | 2013-02-26 |
EP2258349B1 (en) | 2014-07-16 |
EP1758557B1 (en) | 2011-07-13 |
ATE516019T1 (de) | 2011-07-15 |
US20080299199A1 (en) | 2008-12-04 |
DK2258349T3 (da) | 2014-10-13 |
US20120039969A1 (en) | 2012-02-16 |
JP2007537169A (ja) | 2007-12-20 |
US8383155B2 (en) | 2013-02-26 |
WO2005107713A3 (en) | 2006-05-18 |
ES2370729T3 (es) | 2011-12-22 |
EP2258349A2 (en) | 2010-12-08 |
EP1758557A2 (en) | 2007-03-07 |
CA2566793A1 (en) | 2005-11-17 |
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