JP5792074B2 - 経皮薬剤の試験方法と装置 - Google Patents
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D29/00—Filters with filtering elements stationary during filtration, e.g. pressure or suction filters, not covered by groups B01D24/00 - B01D27/00; Filtering elements therefor
- B01D29/44—Edge filtering elements, i.e. using contiguous impervious surfaces
- B01D29/48—Edge filtering elements, i.e. using contiguous impervious surfaces of spirally or helically wound bodies
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
Description
− 薬剤投与形態の開発と薬剤組成の最適化。
− 多種成分の経皮投与薬剤を製造する段階における、設定された目標の監視(例え
ば、制御の変更、製造技術または製剤組成の改変のため)。
− 工程内制御および放出制御。
− 生物学的同等性の研究。
1.1 反極性を持つ液体間での分配
1.2 開放タンク方式
1.3 ゲル拡散方式(寒天、ゼラチン)
2.1 装置による分類
2.1.1. セル内平衡拡散方式
2.1.2. 流下式セル方式
2.2 膜のタイプによる分類
2.2.1 天然の膜
2.2.1.1 人体皮膚からの膜
2.2.2. 合成膜
ブロック型の日本製オムロンE5CSV-R1 T-500 温度制御器を使用する。
調剤のサンプルを塗布する。サンプルの塗布量は、膜の面積に対して約0.001〜0.1g/cm2である。
トロキセルチン5%ゲルの膜浸透試験
試験用調剤は、有効成分として5%トロキセルチンを含んでいる。この試験では、塩化ナトリウム0.9重量%の溶液を、受容体相として用いる。受容体相の流速は、1mm/分である。この試験で使用した膜は、幅10cm、長さ10cmのセロファンである。セルの温度は、34度Cである。セルは、昼間の自然光に曝されている。1回目の試験(I)では、人工的な空気流を起こしていない。2回目の試験(II )での、空気流の線速度は、2メートル/秒である。有効成分の濃度は、波長349 nmの紫外線分光分析法によってオンラインで測定する。
セロファン膜および人体皮膚膜使用時のpiroxicam含有クリームの膜浸透比較試験
試験用調剤は有効成分として1%piroxicam を含有する。この試験において、受容体相は0.9重量%の塩化ナトリウム溶液を含有する。受容体相の流速は0.3 m/分である。
一回目の試験(I)ではセロファン膜を使用、二回目の試験(II)では人体皮膚膜を使用した。セルの温度を34度Cに保った。試験時の間、セルは天然太陽光に露光させた。人工的には空気流をつくらなかった。
2 膜浸透システム
3 試料分析システム(又は、検体濃度オンライン分析システム)
4 ブロック式又はマイクロプロセッサー制御システム
A 空気温度制御システム
A1 可変速度換気扇
A2 気温センサー
A3 加熱ユニット(又は、加熱エレメント)
C セル温度制御システム
C1 膜浸透セル、セルボディ
C2 温度センサー
C3 加熱ユニット(又は、対流式ラジエーター)
C4 液体温度自動調節器
E1 溶離液タンク
E2 液体クロマトグラフィ用ポンプ
L 光強度制御システム
L1 発光ダイオード
L2 光センサー
S1 紫外/可視波長域蛍光-分光分析器
Claims (8)
- 経皮投与を目的とする美容用又は医薬用製剤の試験装置であって、膜を介して前記製剤の有効成分を浸透させるための受容体相を脱ガス処理し、供給するシステムと、開放式試料コンパートメントを備える膜浸透セルを有する膜浸透システムと、前記膜に接触した受容体相から試料を採取し、分析するシステムと、制御システムと、前記膜浸透セルの開放式試料コンパートメントの表面における、1つ又はそれ以上の数の環境要因を調整及び制御するのに適した手段とを含み、前記膜浸透セルの開放式試料コンパートメントにおける、調整可能かつ制御可能な環境変量は、光の強度、光の波長、空気の流速、気温及び湿度から選択されることを特徴とする装置。
- 前記膜浸透セルは、前記受容体相の供給及び排出のための入口及び出口と、セル体と、前記膜と、前記セル体に前記膜を固定する手段と、温度制御可能なジャケットと、断熱材とを有することを特徴とする請求項1に記載の装置。
- 前記膜浸透セルの容積と膜側の断面積が、高い精度で定められていることを特徴とする請求項2に記載の装置。
- 経皮投与を目的とする美容用又は治療薬用製剤の試験方法であって、請求項1〜3のいずれか1項に記載の装置の膜浸透セルの表面に装着した膜に試料を移し、該試料を予め選択及び制御された環境要因に曝し、同時に一定温度で流速制御された受容体相をセル体経由で供給し、排出液中に含まれる試験試料の薬学的有効成分又は特徴的組成分の濃度を測定する工程を有することを特徴とする方法。
- 1項目又はそれ以上の項目の環境要因を、温度、光の強度、光の波長、空気の流速、気温及び湿度の中から選び、前記膜浸透セル開放表面及び前記膜浸透セルの付近にて制御することを特徴とする請求項4に記載の方法。
- 前記受容体相として、水、塩水、リンゲル液、リン酸緩衝生理食塩水、界面活性剤水溶液、又はたんぱく質の水溶液を使用する請求項4又は5に記載の方法。
- 前記たんぱく質の水溶液は、人体血清アルブミンの水溶液であることを特徴とする請求項6に記載の方法。
- 試験を恒温状態で行う、請求項4〜7のいずれか1項に記載の方法。
Applications Claiming Priority (3)
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HUP0900073 | 2009-02-06 | ||
HU0900073A HUP0900073A2 (en) | 2009-02-06 | 2009-02-06 | Process and equipment for inquiry medical product on dermal surface |
PCT/HU2010/000017 WO2010089619A1 (en) | 2009-02-06 | 2010-02-08 | Method and apparatus for testing transdermal medicaments |
Publications (2)
Publication Number | Publication Date |
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JP2012517589A JP2012517589A (ja) | 2012-08-02 |
JP5792074B2 true JP5792074B2 (ja) | 2015-10-07 |
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JP2011548790A Expired - Fee Related JP5792074B2 (ja) | 2009-02-06 | 2010-02-08 | 経皮薬剤の試験方法と装置 |
Country Status (10)
Country | Link |
---|---|
US (1) | US20120167671A1 (ja) |
EP (1) | EP2394168B1 (ja) |
JP (1) | JP5792074B2 (ja) |
KR (1) | KR20110115596A (ja) |
CN (1) | CN102369439B (ja) |
BR (1) | BRPI1005437A2 (ja) |
CA (1) | CA2751635A1 (ja) |
HU (2) | HUP0900073A2 (ja) |
WO (1) | WO2010089619A1 (ja) |
ZA (1) | ZA201105957B (ja) |
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GB201314252D0 (en) * | 2013-08-08 | 2013-09-25 | Smiths Detection Watford Ltd | Apparatus and method |
WO2016081810A1 (en) | 2014-11-21 | 2016-05-26 | Absorption Systems Group, Llc | System for the concomitant assessment of drug dissolution, absorption and permeation and methods of using the same |
CN109187894B (zh) * | 2018-08-30 | 2021-08-24 | 日照市中医医院 | 一种西药成分检验装置 |
US11668723B2 (en) | 2019-07-09 | 2023-06-06 | Logan Instruments Corporation | Automated dissolution/permeation testing system |
CN114868019A (zh) * | 2019-11-15 | 2022-08-05 | 纳米制药有限公司 | 用于口服吸入药物产品的体外释放测试(ivrt)装置 |
DE102020130492A1 (de) * | 2020-11-18 | 2022-05-19 | Lts Lohmann Therapie-Systeme Ag. | Temperiersystem für eine Diffusionszelle, Diffusionszelle, Diffusionszellensystem, sowie Verfahren zur Temperierung in einer Diffusionszelle |
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EP0242326A3 (de) * | 1986-04-15 | 1990-04-18 | Pharmatronic AG | Einrichtung zur Untersuchung der Diffusion einer Substanz und Verfahren zum Betrieb der Einrichtung |
US4740309A (en) * | 1986-08-29 | 1988-04-26 | Iprx, Inc. | Methods and apparatus for determining the rate of movement of a study substance through a membrane |
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US5547351A (en) * | 1994-03-01 | 1996-08-20 | The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services | Low pressure low volume liquid pump |
US5659130A (en) * | 1996-04-03 | 1997-08-19 | Industrual Technology Research Institute | Simple device for testing chemical permeation |
AU1623099A (en) * | 1997-12-22 | 1999-07-12 | Alza Corporation | Rate controlling membranes for controlled drug delivery devices |
US6360588B1 (en) * | 1998-10-27 | 2002-03-26 | Edward Allan Ross | Materials and methods for the analysis of substances passing through a membrane |
DE29911790U1 (de) * | 1999-07-07 | 1999-09-30 | Novosis Pharma Ag | Permeationszelle zur in-vitro-Bestimmung der Hautpermeation von pharmazeutischen Wirkstoffen |
WO2003076927A1 (en) * | 2002-03-05 | 2003-09-18 | North Carolina State University | Method and apparatus for determining a molecular descriptor of absorption for a candidate compound |
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CA2520439A1 (en) * | 2003-03-28 | 2004-10-07 | Alza Corporation | Static diffusion cell for diffusion sampling systems |
PT1670433E (pt) * | 2003-10-10 | 2012-02-08 | Ferring Bv | Fórmula farmacológica transdérmica para a minimização de resíduos na pele |
JP2007064718A (ja) * | 2005-08-30 | 2007-03-15 | Sumitomo Chemical Co Ltd | 可視光皮膚刺激誘発能力の検定方法、及びその利用 |
WO2008093412A1 (ja) * | 2007-01-31 | 2008-08-07 | Cosmed Pharmaceutical Co., Ltd. | 経皮吸収製剤の拡散測定装置 |
US8322193B2 (en) * | 2009-11-23 | 2012-12-04 | Logan Instruments Corp. | Transdermal diffusion cell testing arrangements and methods |
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- 2010-02-08 JP JP2011548790A patent/JP5792074B2/ja not_active Expired - Fee Related
- 2010-02-08 EP EP10707661.4A patent/EP2394168B1/en active Active
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KR20110115596A (ko) | 2011-10-21 |
BRPI1005437A2 (pt) | 2017-04-25 |
HUE033300T2 (en) | 2017-11-28 |
EP2394168A1 (en) | 2011-12-14 |
US20120167671A1 (en) | 2012-07-05 |
JP2012517589A (ja) | 2012-08-02 |
CN102369439B (zh) | 2014-12-17 |
HUP0900073A2 (en) | 2010-11-29 |
EP2394168B1 (en) | 2017-04-05 |
HU0900073D0 (en) | 2009-03-30 |
ZA201105957B (en) | 2012-10-31 |
CN102369439A (zh) | 2012-03-07 |
CA2751635A1 (en) | 2010-08-12 |
WO2010089619A1 (en) | 2010-08-12 |
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