JP6487949B2 - 局所用コルチコステロイド組成物 - Google Patents
局所用コルチコステロイド組成物 Download PDFInfo
- Publication number
- JP6487949B2 JP6487949B2 JP2016575611A JP2016575611A JP6487949B2 JP 6487949 B2 JP6487949 B2 JP 6487949B2 JP 2016575611 A JP2016575611 A JP 2016575611A JP 2016575611 A JP2016575611 A JP 2016575611A JP 6487949 B2 JP6487949 B2 JP 6487949B2
- Authority
- JP
- Japan
- Prior art keywords
- composition
- skin
- betamethasone
- alcohol
- spray
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
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- 229940005605 valeric acid Drugs 0.000 description 1
- 238000009834 vaporization Methods 0.000 description 1
- 230000008016 vaporization Effects 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
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- NCYCYZXNIZJOKI-UHFFFAOYSA-N vitamin A aldehyde Natural products O=CC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C NCYCYZXNIZJOKI-UHFFFAOYSA-N 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 229920001221 xylan Polymers 0.000 description 1
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- 239000005019 zein Substances 0.000 description 1
- 229940093612 zein Drugs 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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Description
本発明の分野
局所薬物送達システムは、局所的な様々な皮膚障害の治療のためには、理想的な選択である。軟膏、クリーム、ゲル、スプレー等のような局所投与形態は、皮膚の罹患部へ活性薬剤を送達することが可能である。
本願の態様は、a)コルチコステロイド;b)少なくとも1つの脂肪族アルコール;c)少なくとも1つの医薬および/または皮膚科学的に許容な賦形剤;およびd)水を含む水性局所用スプレー組成物に関する。
a)乳化剤および油性層を得るための水非混和性物質を含む混合物を加熱し;
b)任意に、a)の油性層と抗酸化剤、防腐剤、または両方を混合し;
c)活性薬剤を浸透エンハンサーと混合し、
d)c)の物質をa)またはb)の混合物と混合し;
e)水性相を形成するためにポリマーを水に溶解し;そして
f)d)の油性層をe)の水性層と混合してエマルジョンを形成する
ことを含む、水性局所用スプレー組成物の製造方法に関する。
本明細書中で用いられている用語「安定した」とは、局所用組成物中の活性薬剤の物理的安定性および/または化学的安定性に言及し、薬品分析値および/または不純物含有量における変化は、25℃および相対湿度(RH)60%、または30℃およびRH65%、または40℃およびRH75%、3、6、12、18、または24ヶ月の継続時間における組成物の貯蔵安定性試験の間に、約10%よりも低い。
a)油性相を得るために、乳化剤および水非混和性物質を含む混合物を加熱し;
b)必要に応じて、抗酸化剤、防腐剤または両方を、a)の油相とともに混合し;
c)浸透エンハンサーとともに活性薬剤を混合し;
d)a)またはb)の混合物とともにc)の材料を混合し;
e)水性相を形成させるために水にポリマーを溶解し;そして
f)e)の水性相とともにd)の油性相と混合し、エマルジョンを形成する
ことを含む局所用スプレー組成物の製造方法に関する。
前記システムへの組成物の導入は、システムの圧をさらに増加させることができ、それは弁を備えた作動装置内へ前記袋またはバッグから組成物を投薬でき、組成物は、スプレーの形態で作動により放出される。
他の乳化剤は、ラウリル硫酸ナトリウム、セチルトリアルキルアンモニウムブロミド、ポリオキシエチレンソルビタン脂肪酸エステル、またはこれらの任意の混合物を含む。
アニオン性乳化剤の非限定的な例は、アルキルがエチオネートである、アルキルおよびアルキルエーテルスルフェートおよびその塩、アルキルおよびアルキルエーテルホスフェートおよびその塩、アルキルメチルタウレート、および脂肪酸の石鹸(例えば、アルカリ金属塩およびナトリウムまたはカリウム塩)を含む。
抗酸化剤、特に脂溶性抗酸化剤は、酸素ラジカルを中和するために細胞膜内に吸収されることができ、従って、膜を保護できる。本願の組成物の適切な抗酸化剤は、限定されることなく、アスコルビン酸(ビタミンC)、グルタチオン、リポ酸、尿酸、カロチン、α-トコフェロール(ビタミンE)、ユビキノール、ブチル化ヒドロキシアニソール、ブチル化ヒドロキシトルエン、ナトリウムベンゾエート、プロピルガレート(PG、E310)および第3級ブチルヒドロキノンを含む。
抗酸化剤の量は、組成物の全重量の約0.01〜約20%であり得る。
の式を用いて計算される。
コルチコステロイド;およびそれを必要とする患者の皮膚の患部上に、該組成物のスプレーを直接送達することを含む局所用スプレー組成物を有する装置を提供する工程を含み、ここで前記装置は、ストローク当たりのスプレー組成物約65mg〜約210mgを送達し、ここで、装置内の組成物が空になるためにスプレーは、約230〜約270ストロークを数える。
a)活性薬剤および1以上の適切な賦形剤を含む組成物を調製し;および
b)投薬装置内に前記の組成物の所望の量を充填することを含む。
a)油性相を得るために乳化剤および溶媒を含む混合物を加熱し;
b)任意に、a)の油性相中に抗酸化剤および/または防腐剤を混ぜ;
c)コルチコステロイドと浸透エンハンサーとを混ぜ;
d)c)の材料と、a)またはb)の材料とを混ぜ、
e)水性相にポリマーを溶解させ;
f)連続的に混合しながらd)の油性相と、e)の水性相とをゆっくり混ぜ;そして
g)f)の混合物をホモジナイズして、その後冷却する
を含む。
E-異性体の形成が、温度の上昇によって増加することが見出された。
i. 薬物溶液の調製:絶えず撹拌しながらベタメタゾンジプロピオネートおよびブチル化ヒドロキシトルエンを、オレイルアルコールに溶解した;
ii. 油相の調製:ソルビタンモノステアレート、ポリオキシ20 セトステアリルエーテル、セトステアリルアルコールおよび鉱油をステンレス鋼容器内で70±2℃迄加熱した。プロピルパラベンを油相に添加した;
iii. 工程1で調製した薬物溶液を、撹拌下に油相にゆっくり加えた。ステンレス鋼容器の温度は70±2℃以下。
iv. 水相の調製:水およびメチルパラベンをホモジナイズし、調製した水相に若干のヒドロキシエチルセルロースを加えた;
v.油相および水相をホモジナイズした。ホモジナイズを、2400rpmで10分間継続した;そして
vi.次いで、前記の容器を、ウォータージャケットを用い、250rpm度撹拌下に、30℃±2℃で冷却し、室温に冷却した。
様々な保管点における試験を表1に示すが、そこでの値は、標識薬物含有量の百分率である。
実施例1〜16の組成物の局所吸収および浸透試験
本願の局所用スプレー組成物は、皮膚の異なる層への薬物の浸透および鉛直拡散セル(フランツ型(Franz-type))を用いる有限投与方法(finete dosing method)による受容体相への浸透について評価した。
この調査において、ヒトの死体皮膚を用いた。採皮したヒト死体皮膚細胞は、約350〜450μmの平均厚みを有する。提供者の組織は、拡散セルの間で均等に分割した。
実施例1〜16の局所用スプレー組成物を、鉛直拡散セル(フランツ型)を用いて評価した。皮膚試料を、個々の拡散セルに取り付けた。各位置のセルは、拡散面積0.503cm2(直径8mm)を有していた。個々のセル各々は、静的フランツ-セル型である。受容体室は、ゲンタマイシンサルフェート0.01%を追加した4%BSA水溶液3.0mlで満たされ、激しく継続的に混合した。温度を32±0.2℃に設定した。投与前に、セルを1時間32℃でインキュベートした。インキュベーション時間の終わりに、レセプター液から試料をt=0の試料として獲得した。予め32℃でインキュベートしたレセプター液の新鮮なバッチを、HTSセルのレセプター室内へ導入した。前記の組成物を、セル当たり約2.5mgのレベルで投与し、それは5mg/cm2に等しく、それらを、容積式ピペットを用いて投与した。投与容量を各組成物の密度を計算することにより計算した。試料を、0時間、1時間、2時間、6時間、10時間、12時間または24時間の間隔で収集し、分析前に、フリーザーにおいて貯蔵した。皮膚浸透試験を、0、2、6、10、12または24時間で獲得した試料により分析し、そしてフルマスバランス試験を24時間後に実施した。
ベタメタゾン 17-プロピオネート、ベタメタゾン 21-プロピオネートおよびベタメタゾン主成分は、親薬物ベタメタゾンジプロピオネートの代謝物である。
ベタメタゾンジプロピオネートスプレーの刺激パッチテスト試験
i. ベタメタゾンジプロピオネートスプレー(実施例6)、
ii.賦形剤スプレー(実施例6の活性薬物なし)、
iii.賦形剤ローション(イソプロピルアルコール、ヒドロキシプロピルセルロース、リン酸一ナトリウム一水和物、プロピレングリコール、リン酸、水酸化ナトリウムおよび水、すなわち、0.05%増加されたジプロレンローション)、
iv.0.2%ラウリル硫酸ナトリウム(SLS)、および
v. 0.9%生理食塩水。
賦形剤ローション部位および0.2%SLS部位において、ベタメタゾンジプロピオネートスプレー部位、賦形剤スプレー部位および0.9%無菌生理食塩水部位よりも顕著なさらに強い刺激が観察された。賦形剤ローション部位および0.2%SLS部位の間の刺激において顕著な差はなく、ベタメタゾンジプロピオネートスプレー部位、賦形剤スプレー部位および0.9%無菌生理食塩水部位の間の刺激において顕著な差はなかった。21日間の半密封下の連続暴露を伴う、この試験における使用の強調された条件下、ベタメタゾンジプロピオネートスプレー(実施例6)およびその賦形剤スプレー(実施例6の活性薬物なし)は、有意な刺激差の証拠を何ら生じなかった。比較すると、賦形剤ローション部位および軽度の刺激で知られている0.2%SLS部位との間に有意差はなかったので、賦形剤ローション(0.05%増加されたジプロリンローション)は、軽度の刺激を生じた。
実施例6の組成物のスプレー特性
Claims (20)
- a)コルチコステロイドであるベタメタゾン化合物;b)オレイルアルコールを含む皮膚浸透エンハンサー;c)少なくとも1つの医薬的および/または皮膚科学的に許容な賦形剤;ならびにd)水を含むが、プロピレングリコールを含まず、実質的に非発泡性の水性局所用スプレー組成物であって、
i)該組成物が皮膚デポー剤組成物であるか、
ii)該組成物におけるエノールアルデヒド不純物が、25℃で少なくとも6ヶ月期間約1%よりも低いか、または
iii)該組成物が、皮膚層に適用量の約0.1%〜約20%のベタメタゾン化合物の保持を提供する
水性局所用スプレー組成物。 - 前記組成物が、どんなフィルム層も形成しない、請求項1に記載の組成物。
- 前記皮膚浸透エンハンサーが、リノレイルアルコール、リノレニルアルコール、ベヘニルアルコール、セトステアリルアルコール、2−ヘプチル−1−ウンデカノール、1,17−ヘプタデカンジオール、エライジルアルコール、カプリルアルコール、ラウリルアルコール、ステアリルアルコールおよびそれらの混合物からなる群から選択される1以上の脂肪アルコールをさらに含み;ここで脂肪アルコールが、全組成物の約0.01重量%〜約15重量%の量で存在する、請求項1に記載の組成物。
- 前記ベタメタゾン化合物が、ベタメタゾンベンゾエート、ベタメタゾンジプロピオネート、ベタメタゾンナトリウムホスフェート、ベタメタゾンバレレートおよびそれらの組み合わせからなる群から選択され、前記ベタメタゾン化合物が、製品の約0.025重量%〜約0.1重量%に相当する量で存在する、請求項1に記載の組成物。
- 前記医薬的および/または皮膚科学的に許容な賦形剤が:
カチオン性界面活性剤、アニオン性界面活性剤、双極性イオン性界面活性剤および両性界面活性剤ならびにそれらの組み合わせからなる群から選択される乳化剤;
ポリオキシ20 セトステアリルエーテルを含む乳化剤;または
カルボマー、ポリエチレングリコール、アクリレートポリマー、メタクリレートポリマー、ポリビニルピロリドン、ブチルメタクリレートおよびメチルメタクリレートに基づくコポリマー、ビニルアセテート、ポリビニルアセテート、セルロース、ガム、アルギネート、セルロースアセテートフタレート、セルロースアセテートブチレート、ヒドロキシプロピルメチルセルロースフタレートおよびそれらの組み合わせからなる群から選択されるポリマー
である、請求項1に記載の組成物。 - 1以上の抗酸化剤、防腐剤、湿潤剤または可塑剤またはセトステアリルアルコールをさらに含む、請求項1に記載の組成物。
- 前記組成物が、患者の皮膚に対して実質的に非刺激性であり;ここで前記組成物が、40℃で少なくとも約6ヶ月の期間または25℃で少なくとも約24ヶ月の期間安定であり、ここで前記組成物が実質的に高圧ガスを含まない、請求項1に記載の組成物。
- 前記ベタメタゾン化合物が、ベタメタゾンジプロピオネートである、請求項1に記載の組成物。
- 前記組成物におけるエノールアルデヒド不純物が、25℃で少なくとも12ヶ月期間約1%よりも低く;前記組成物におけるエノールアルデヒド不純物が、25℃で少なくとも18ヶ月期間約1%よりも低く;前記組成物におけるエノールアルデヒド不純物が、25℃で少なくとも24ヶ月期間約1%よりも低く;または2〜8℃で貯蔵した場合に、少なくとも約12ヶ月の期間前記組成物が、エノールアルデヒド不純物を実質的に含まない、請求項1に記載の組成物。
- 前記組成物が、皮膚層において適用量の約0.1%〜約10%のベタメタゾン化合物の保持を提供するか;または前記組成物が、適用量の約10%より低いベタメタゾン化合物の全身暴露を提供する、請求項1に記載の組成物。
- 前記組成物が、皮膚デポー組成物である、請求項1に記載の組成物。
- 前記組成物が、水性エマルジョンであるか、または水中油型エマルジョンである、請求項1に記載の組成物。
- 前記組成物が、約35mm〜約60mmの第1軸、約35mm〜約55mmの第2軸を有する、広い角度の完全な円錐状のスプレーパターンのスプレー特性を提供する装置で提供される、アトピー性皮膚炎、脂漏性皮膚炎、湿疹および乾癬の治療に有益な請求項1に記載の組成物。
- 前記装置が、約1〜約1.5である第1および第2軸の間の比率を提供するか、または作動当たりの組成物約65mg〜約210mgを送達する、請求項13に記載の組成物。
- 前記スプレーパターンが、投与距離が患者の皮膚から装置まで約20mm〜約60mmであり、かつスプレー角度が患者の皮膚に対して約50〜70度である場合に得られ、ここで、前記装置は、機械的に作動され得る取り付けられたスプレーポンプクロージャーを備えたボトルである、請求項13に記載の組成物。
- 前記組成物が、密閉フィルムを形成せずに皮膚にデポーを形成し;ここで前記組成物が水性エマルジョンであるか;または前記組成物が約10〜約15,000センチポアズの粘度を有する、請求項13に記載の組成物。
- 前記組成物が:a)ベタメタゾン化合物;b)オレイルアルコール;c)少なくとも1つの医薬的および/または皮膚科学的に許容な賦形剤;ならびにd)水;を含む水性局所用スプレー組成物である、請求項13に記載の組成物。
- a)油性相を得るために乳化剤および水非混和性物質を含む混合物を加熱し;
b)コルチコステロイドであるベタメタゾン化合物を、オレイルアルコールを含む皮膚浸透エンハンサーと混ぜ;
c)b)の材料をa)の混合物と混ぜ;
d)水性相を形成するためにポリマーを水に溶解させ;
e)エマルジョンを形成するためにc)の油性相をd)の水性相と混ぜる;
工程を含む、請求項1に記載の組成物の製造方法。 - 前記ポリマーがヒドロキシエチルセルロースであり、そして前記皮膚浸透エンハンサーがオレイルアルコールである、請求項18に記載の製造方法。
- 工程a)の前記加熱が70±2℃に至るまでであり;前記工程e)が2400rpmで10分間のホモジナイズを含む、請求項18に記載の製造方法。
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KR20190055153A (ko) | 2016-09-21 | 2019-05-22 | 아벡신 에이에스 | 약학 조성물 |
US10543177B2 (en) | 2017-04-11 | 2020-01-28 | Kevin Mrohs | Composition and method for treating skin conditions |
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WO2021080527A1 (en) * | 2019-10-24 | 2021-04-29 | Pharmacti̇ve İlaç Sanayi̇ Ve Ti̇caret A.Ş. | Topical pharmaceutical compositions containing difluocortolone and isoconazole |
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US11382863B2 (en) * | 2020-03-04 | 2022-07-12 | Somerset Therapeutics Llc | Injectable suspension comprising an insoluble corticosteroid and a soluble corticosteroid |
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