JP6937072B2 - 口腔内崩壊錠の評価方法及び口腔内崩壊錠の評価装置 - Google Patents
口腔内崩壊錠の評価方法及び口腔内崩壊錠の評価装置 Download PDFInfo
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- 239000006191 orally-disintegrating tablet Substances 0.000 title claims description 266
- 238000011156 evaluation Methods 0.000 title claims description 53
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 135
- 238000010521 absorption reaction Methods 0.000 claims description 132
- 239000012085 test solution Substances 0.000 claims description 48
- 238000004458 analytical method Methods 0.000 claims description 44
- 238000000034 method Methods 0.000 claims description 27
- 238000012360 testing method Methods 0.000 claims description 25
- 239000007788 liquid Substances 0.000 claims description 23
- 238000009472 formulation Methods 0.000 claims description 20
- 239000000203 mixture Substances 0.000 claims description 20
- 238000005259 measurement Methods 0.000 claims description 17
- 239000012466 permeate Substances 0.000 claims description 10
- 239000003826 tablet Substances 0.000 claims description 8
- 238000003860 storage Methods 0.000 description 16
- 210000000214 mouth Anatomy 0.000 description 10
- 238000010586 diagram Methods 0.000 description 3
- 229940088679 drug related substance Drugs 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000008186 active pharmaceutical agent Substances 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 210000003296 saliva Anatomy 0.000 description 2
- 239000000120 Artificial Saliva Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 230000008676 import Effects 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
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- G01N15/08—Investigating permeability, pore-volume, or surface area of porous materials
- G01N15/082—Investigating permeability by forcing a fluid through a sample
- G01N15/0826—Investigating permeability by forcing a fluid through a sample and measuring fluid flow rate, i.e. permeation rate or pressure change
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- 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
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- G01N5/00—Analysing materials by weighing, e.g. weighing small particles separated from a gas or liquid
- G01N5/02—Analysing materials by weighing, e.g. weighing small particles separated from a gas or liquid by absorbing or adsorbing components of a material and determining change of weight of the adsorbent, e.g. determining moisture content
- G01N5/025—Analysing materials by weighing, e.g. weighing small particles separated from a gas or liquid by absorbing or adsorbing components of a material and determining change of weight of the adsorbent, e.g. determining moisture content for determining moisture content
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/20—Pills, tablets, discs, rods
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
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Description
図1は、本発明の一実施形態に係る口腔内崩壊錠の評価装置100を示す模式図である。図1(a)は、口腔内崩壊錠の評価装置100のブロック構成図であり、図1(b)は、試験液供給部110及び吸水時間測定部120を示す模式図である。口腔内崩壊錠の評価装置100は、例えば、試験液供給部110と、吸水時間測定部120と、解析部130と、を備えるが、これに限定されるものではない。
上述した口腔内崩壊錠の評価装置を用いた口腔内崩壊錠の評価方法について、以下に説明する。
Claims (7)
- 前記口腔内崩壊錠とは異なる複数の任意の口腔内崩壊錠について、前記吸水時間を別途測定し、
前記吸水時間を測定した前記複数の任意の口腔内崩壊錠の質量を別途測定し、
前記式(1)により、前記複数の任意の口腔内崩壊錠の吸水速度を別途算出し、
前記複数の任意の口腔内崩壊錠と同系統の処方の口腔内崩壊錠の口腔内崩壊時間を別途測定し、
前記複数の任意の口腔内崩壊錠の吸水速度に対して、前記複数の任意の口腔内崩壊錠と同系統の処方の口腔内崩壊錠の口腔内崩壊時間の逆数をプロットし、前記複数の任意の口腔内崩壊錠の吸水速度と口腔内崩壊時間の逆数との相関曲線を得ること、
前記口腔内崩壊時間を求める口腔内崩壊錠の吸水速度を前記式(1)により算出し、
前記相関曲線から、前記口腔内崩壊時間を求める口腔内崩壊錠の吸水速度に対応する口腔内崩壊時間を得ること、及び
得られた前記口腔内崩壊時間に基づいて、前記口腔内崩壊錠の前記崩壊性を評価すること、をさらに含むことを特徴とする、請求項1に記載の口腔内崩壊錠の評価方法。 - 前記口腔内崩壊錠は、長軸と、前記長軸に交差する短軸と、を有する形状を備え、
前記試験液供給部の製剤配置面に対して、前記口腔内崩壊錠の長軸方向が略平行となるように、前記口腔内崩壊錠を前記試験液供給部の前記製剤配置面に配置し、
前記製剤配置面に接する前記口腔内崩壊錠の一端から、前記口腔内崩壊錠の短軸方向に前記一端から最も離れた前記口腔内崩壊錠の他端まで試験液が浸透する吸水時間を測定することを特徴とする、請求項1に記載の口腔内崩壊錠の評価方法。 - 前記口腔内崩壊錠の他端まで試験液が浸透したことを、前記口腔内崩壊錠の他端の色調の変化で判断することを特徴とする、請求項3に記載の口腔内崩壊錠の評価方法。
- 前記吸水時間測定部は、前記口腔内崩壊錠とは異なる複数の任意の口腔内崩壊錠について、一端から他端まで前記試験液が浸透する吸水時間を別途測定し、
前記解析部は、前記質量測定部で測定した前記複数の任意の口腔内崩壊錠の質量と、前記試験液が浸透する時間を測定した前記複数の任意の口腔内崩壊錠の前記質量測定部で測定した質量とを用いて、前記式(1)により、前記複数の任意の口腔内崩壊錠の吸水速度を別途算出し、
前記解析部は、前記複数の任意の口腔内崩壊錠と同系統の処方の口腔内崩壊錠の口腔内崩壊時間が別途入力され、
前記複数の任意の口腔内崩壊錠の吸水速度と前記複数の任意の口腔内崩壊錠と同系統の処方の口腔内崩壊錠の口腔内崩壊時間の逆数との相関曲線を提供し、
前記解析部は、口腔内崩壊時間を求める口腔内崩壊錠の吸水速度を前記式(1)により算出し、
前記相関曲線から、前記口腔内崩壊時間を求める口腔内崩壊錠の吸水速度に対応する口腔内崩壊時間を算出することを特徴とする、請求項5に記載の口腔内崩壊錠の評価装置。 - 前記吸水時間測定部は、前記口腔内崩壊錠の他端の色調を計測し、
前記解析部は、前記口腔内崩壊錠の他端の色調の変化に基づき、前記口腔内崩壊錠の他端まで試験液が浸透したことを判断することを特徴とする、請求項6に記載の口腔内崩壊錠の評価装置。
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US2575169A (en) * | 1948-09-17 | 1951-11-13 | Stromberg Carlson Co | Method of determining the rate of moisture absorption |
US3952584A (en) * | 1975-03-04 | 1976-04-27 | Lichstein Bernard M | Measurement of absorbency characteristics of absorbent structures |
US4357827A (en) * | 1980-05-12 | 1982-11-09 | Johnson & Johnson | Gravimetric absorbency tester |
JP4891713B2 (ja) * | 2006-09-07 | 2012-03-07 | エーザイ・アール・アンド・ディー・マネジメント株式会社 | 崩壊試験装置及び崩壊試験方法 |
US8176769B2 (en) * | 2008-04-01 | 2012-05-15 | Andrew Kallmes | Fluid transportation by a plurality of particulates |
JP5205291B2 (ja) * | 2009-01-15 | 2013-06-05 | 京都薬品工業株式会社 | 錠剤の崩壊試験装置及び崩壊試験方法 |
US8493441B2 (en) * | 2009-09-11 | 2013-07-23 | Thonhauser Gmbh | Absorbance measurements using portable electronic devices with built-in camera |
JP6061516B2 (ja) * | 2011-07-14 | 2017-01-18 | 協和発酵キリン株式会社 | ドンペリドン口腔内崩壊錠 |
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