JP2014517100A5 - - Google Patents
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- JP2014517100A5 JP2014517100A5 JP2014509313A JP2014509313A JP2014517100A5 JP 2014517100 A5 JP2014517100 A5 JP 2014517100A5 JP 2014509313 A JP2014509313 A JP 2014509313A JP 2014509313 A JP2014509313 A JP 2014509313A JP 2014517100 A5 JP2014517100 A5 JP 2014517100A5
- Authority
- JP
- Japan
- Prior art keywords
- talc
- free composition
- free
- tack
- coating
- 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.)
- Granted
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- 239000000203 mixture Substances 0.000 claims description 37
- 239000011248 coating agent Substances 0.000 claims description 16
- 238000000576 coating method Methods 0.000 claims description 16
- 239000002671 adjuvant Substances 0.000 claims description 12
- 230000000240 adjuvant Effects 0.000 claims description 12
- 239000007909 solid dosage form Substances 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 239000007787 solid Substances 0.000 claims description 8
- 238000009472 formulation Methods 0.000 claims description 6
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 4
- 230000035699 permeability Effects 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 4
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 3
- 230000005540 biological transmission Effects 0.000 claims description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 3
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 3
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 3
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2R,3R,4S,5R,6S)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2S,3R,4S,5R,6R)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2R,3R,4S,5R,6R)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- VUKAUDKDFVSVFT-UHFFFAOYSA-N 2-[6-[4,5-bis(2-hydroxypropoxy)-2-(2-hydroxypropoxymethyl)-6-methoxyoxan-3-yl]oxy-4,5-dimethoxy-2-(methoxymethyl)oxan-3-yl]oxy-6-(hydroxymethyl)-5-methoxyoxane-3,4-diol Chemical compound COC1C(OC)C(OC2C(C(O)C(OC)C(CO)O2)O)C(COC)OC1OC1C(COCC(C)O)OC(OC)C(OCC(C)O)C1OCC(C)O VUKAUDKDFVSVFT-UHFFFAOYSA-N 0.000 claims description 2
- 239000005913 Maltodextrin Substances 0.000 claims description 2
- 229920002774 Maltodextrin Polymers 0.000 claims description 2
- 239000004480 active ingredient Substances 0.000 claims description 2
- 239000002270 dispersing agent Substances 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- 229940035034 maltodextrin Drugs 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- 239000004014 plasticizer Substances 0.000 claims description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 239000002313 adhesive film Substances 0.000 claims 1
- 239000000454 talc Substances 0.000 claims 1
- 229910052623 talc Inorganic materials 0.000 claims 1
- 229950008882 Polysorbate Drugs 0.000 description 2
- 229920000136 polysorbate Polymers 0.000 description 2
- 235000015872 dietary supplement Nutrition 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
Description
実施例により示されるように、タルクフリー組成物は、固形剤形上に不粘着性被膜又はコーティングを形成することができ、この被膜又はコーティングは、予想外に、最大で５．０×１０−７ｇ／Ｐａ・ｈ・ｍの平均水蒸気透過率；５００％／ｍｍ超の規格化された被膜明澄度；及び１３％以下の被膜曇り度；及び、幾つかの実施形態において、１３％／ｍｍ未満の規格化された被膜曇り度を含む有利な組み合わせ又は特性を有する。被覆された錠剤は、本発明の不粘着性被膜の実施形態を含むコーティングを有し、医薬、栄養補助食品及び獣医学用の被覆された錠剤用途で使用するのに好適な被膜厚さを有するものである。
本発明に関連する発明の実施態様の一部を以下に示す。
［態様１］
不粘着性であること、最大で５．０×１０ −７ グラム／パスカル・時・メートルの平均水透過率を有すること、及び最大で５．０×１０ −７ グラム／パスカル・時・メートルの平均水蒸気透過率を有する不粘着性被膜を形成する能力を有することにより特徴付けられるタルクフリー組成物。
［態様２］
さらに、被膜厚さ１ミリメートル当たり少なくとも５００％の規格化された被膜明澄度を有することにより特徴付けられる、上記態様１に記載のタルクフリー組成物。
［態様３］
さらに、最大で１３％の被膜曇り度を有することにより特徴付けられる、上記態様１又は２に記載のタルクフリー組成物。
［態様４］
低粘度ポリビニルアルコール及び粘着性低減有機アジュバントから実質的になり、前記組成物中の低粘度ポリビニルアルコールと粘着性低減有機アジュバントの質量／質量比が６０：４０以上から９５：５以下である、上記態様１〜３のいずれか一つに記載のタルクフリー組成物。
［態様５］
粘着性低減有機アジュバントが、カルボキシメチルセルロース、ポリ（エチレングリコール）、ヒドロキシプロピルメチルセルロース、マルトデキストリン、メチルセルロース、もしくはポリビニルピロリドン、又はそれらの組み合わせである、上記態様４に記載のタルクフリー組成物。
［態様６］
粘着性低減有機アジュバントがカルボキシメチルセルロースである、上記態様５に記載のタルクフリー組成物。
［態様７］
さらに、非相殺量の少なくとも１種の第２の有機アジュバントから実質的になり、当該第２の有機アジュバントが可塑剤、界面活性剤又は除去可能な分散剤である、上記態様１〜６のいずれか一つに記載のタルクフリー組成物。
［態様８］
第２の有機アジュバントが、ポリ（エチレングリコール）、ポリソルベート、水、又は、ポリ（エチレングリコール）とポリソルベートと必要に応じて水との組み合わせである、上記態様７に記載のタルクフリー組成物。
［態様９］
被覆された固形剤形の製造方法であって、被覆に有効な量の上記態様１〜８のいずれか一つに記載のタルクフリー組成物を、有効成分を含む固形の保健衛生製剤に接触させることを含み、当該接触が、固形の保健衛生製剤を被覆して、固形の保健衛生製剤と被覆機能的に接触するタルクフリー組成物を含む不粘着性被膜を含む被覆された固形剤形をもたらすように行われる、被覆された固形剤形の製造方法。
［態様１０］
上記態様１〜８のいずれか一つに記載のタルクフリー組成物を含む製品。
［態様１１］
タルクフリー組成物を含む不粘着性被膜を含む被覆された固形剤形を含み、不粘着性被膜は固形の保健衛生製剤と被覆機能的に接触しており、かつ、最大で５．０×１０ −７ グラム／パスカル・時・メートルの平均水透過率を有する、上記態様１０に記載の製品。
［態様１２］
上記態様１〜８のいずれか一つに記載のタルクフリー組成物を含む不粘着性被膜。
As demonstrated by the examples, the talc-free composition can form a tack-free coating or coating on the solid dosage form, which unexpectedly is up to 5.0 × 10 − An average water vapor transmission rate of 7 g / Pa · h · m; a normalized film clarity greater than 500% / mm; and a film haze of 13% or less; and in some embodiments, 13% / It has advantageous combinations or properties including a normalized film haze of less than mm. The coated tablet has a coating that includes the non-stick coating embodiment of the present invention and has a coating thickness suitable for use in coated tablet applications for pharmaceutical, dietary supplement and veterinary medicine Is.
Some of the embodiments of the invention related to the present invention are shown below.
[Aspect 1]
It is non-tacky at most have an average water permeability of 5.0 × 10 -7 g / Pascal at-meters, and a maximum of 5.0 × 10 -7 g / Pascal at-meters A talc-free composition characterized by having the ability to form a tack-free coating having an average water vapor transmission rate.
[Aspect 2]
The talc-free composition according to aspect 1, further characterized by having a normalized film clarity of at least 500% per millimeter of film thickness.
[Aspect 3]
The talc-free composition according to embodiment 1 or 2, further characterized by having a film haze of at most 13%.
[Aspect 4]
The low-viscosity polyvinyl alcohol and the tackiness-reducing organic adjuvant are substantially composed of the low-viscosity polyvinyl alcohol and the tackiness-reducing organic adjuvant in the composition, wherein the mass / mass ratio is 60:40 or more and 95: 5 or less. The talc-free composition according to any one of Embodiments 1 to 3.
[Aspect 5]
The talc-free composition according to aspect 4, wherein the tackiness-reducing organic adjuvant is carboxymethylcellulose, poly (ethylene glycol), hydroxypropylmethylcellulose, maltodextrin, methylcellulose, or polyvinylpyrrolidone, or a combination thereof.
[Aspect 6]
The talc-free composition according to aspect 5, wherein the tackiness-reducing organic adjuvant is carboxymethylcellulose.
[Aspect 7]
Furthermore, any of the above aspects 1-6, consisting essentially of a non-cancelling amount of at least one second organic adjuvant, wherein the second organic adjuvant is a plasticizer, a surfactant or a removable dispersant The talc-free composition according to any one of the above.
[Aspect 8]
The talc-free composition according to aspect 7, wherein the second organic adjuvant is poly (ethylene glycol), polysorbate, water, or a combination of poly (ethylene glycol), polysorbate, and water as necessary.
[Aspect 9]
A method for producing a coated solid dosage form, wherein the talc-free composition according to any one of the above aspects 1 to 8 in an amount effective for coating is contacted with a solid health and hygiene preparation comprising an active ingredient. Wherein the contacting results in a coated solid dosage form comprising a non-tacky coating comprising a talc-free composition that coats the solid health formulation and is functionally in contact with the solid health formulation. A process for producing a coated solid dosage form.
[Aspect 10]
A product comprising the talc-free composition according to any one of the above aspects 1 to 8.
[Aspect 11]
A coated solid dosage form comprising a tack-free coating comprising a talc-free composition, the tack-free coating being in functional contact with the solid health formulation and up to 5.0 × 10 A product according to embodiment 10 above having an average water permeability of -7 grams / pascal / hour / meter.
[Aspect 12]
A tack-free coating comprising the talc-free composition according to any one of the above aspects 1 to 8.
Claims (10)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161482264P | 2011-05-04 | 2011-05-04 | |
| US61/482,264 | 2011-05-04 | ||
| PCT/US2012/034890 WO2012151089A1 (en) | 2011-05-04 | 2012-04-25 | Talc-free polyvinyl alcohol composition |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2014517100A JP2014517100A (en) | 2014-07-17 |
| JP2014517100A5 true JP2014517100A5 (en) | 2015-06-25 |
| JP5956563B2 JP5956563B2 (en) | 2016-07-27 |
Family
ID=46124711
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014509313A Expired - Fee Related JP5956563B2 (en) | 2011-05-04 | 2012-04-25 | Talc-free polyvinyl alcohol composition |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP2705088A1 (en) |
| JP (1) | JP5956563B2 (en) |
| CN (1) | CN103517945B (en) |
| WO (1) | WO2012151089A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7119913B2 (en) * | 2018-10-31 | 2022-08-17 | 三菱ケミカル株式会社 | Film coating composition, solid formulation and method for producing solid formulation |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3672314B2 (en) * | 1994-07-12 | 2005-07-20 | バーウィンド・ファーマスーティカル・サーヴィスィーズ・インコーポレーテッド | Moisture-proof film coating composition, method and coated molded article |
| GB0226763D0 (en) * | 2002-11-15 | 2002-12-24 | Polyval Plc | Polyvinyl alcohol composition and film |
| US20070189978A1 (en) * | 2004-06-07 | 2007-08-16 | Jie Zhang | Compositions and methods for dermally treating musculoskeletal pain |
| US20080274182A1 (en) | 2007-05-03 | 2008-11-06 | Regina Helena Alida Boekema | Tablet coatings made from modified carboxymethylcellulose materials |
| US20100062062A1 (en) | 2008-09-11 | 2010-03-11 | Aethos Pharmaceuticals, Inc. | Stabilized Coating for Pharmaceutical Formulations |
| WO2010124131A1 (en) * | 2009-04-23 | 2010-10-28 | State Of Oregon Acting By And Through The State Board Of Higher Education On Behalf Of Oregaon State University | Flexible films and methods of making and using flexible films |
| CA2759985A1 (en) * | 2009-05-12 | 2010-11-18 | Bpsi Holdings, Llc | Enhanced moisture barrier immediate release film coating systems and substrates coated therewith |
-
2012
- 2012-04-25 CN CN201280021735.1A patent/CN103517945B/en not_active Expired - Fee Related
- 2012-04-25 JP JP2014509313A patent/JP5956563B2/en not_active Expired - Fee Related
- 2012-04-25 WO PCT/US2012/034890 patent/WO2012151089A1/en active Application Filing
- 2012-04-25 EP EP12721984.8A patent/EP2705088A1/en not_active Withdrawn
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