JP3774975B2 - Gel-like sustained release composition - Google Patents
Gel-like sustained release composition Download PDFInfo
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- JP3774975B2 JP3774975B2 JP04089897A JP4089897A JP3774975B2 JP 3774975 B2 JP3774975 B2 JP 3774975B2 JP 04089897 A JP04089897 A JP 04089897A JP 4089897 A JP4089897 A JP 4089897A JP 3774975 B2 JP3774975 B2 JP 3774975B2
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- gel
- sustained release
- release composition
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Description
【0001】
【発明の属する技術分野】
本発明は徐放性組成物に関するものである。さらに詳しくは、ゲル状を呈するため、水なしでも容易に服用でき、薬物の溶出を制御することによって、薬理効果を持続できるという作用を有する徐放性組成物に関するものである。
【0002】
【従来の技術】
従来、徐放性製剤をつくるには、薬物を含有する球形造粒した核粒子にフィルムコーティングを施し、その被膜厚を変えることによって薬剤の溶出時間を制御する方法が用いられていた。また、最近では、皮膜厚を変えることなく、被膜物質そのものに徐放性機能をもたせたり、球形造粒の時点で薬剤と放出制御物質のマトリックス構造を形成させる方法などが用いられている。こうして得られた薬剤はそのままの形態で顆粒剤や散剤として、あるいはカプセル中に封入されたり、錠剤中に包含され得るように成形されて徐放性製剤として提供されている。
【0003】
しかし、これらは通常複雑な製造工程を経るため多くの時間と手間を要し、更に、固形物であるため飲み難く、特に嚥下能力の低い老人や小児にとっては服用が困難な場合があった。また、服用時に水や温湯を必要とすることから、何時でも何処でも服用できるという性質のものではなかった。
【0004】
ここで、服用性に着目した製剤として特開昭56−97220号公報に、水溶性の薬物をカンテンやゼラチンでゲル化したものなどが記載されているが、これらは単に服用性を改良したものであって、薬物の溶出制御を目的としたものではなかった。また、カンテンでは離水し易いためゲルの安定性を確保し難く、ゼラチンでは薬物の溶出を制御することができないので徐放性を有する医薬品の基剤としては適当でなかった。
【0005】
更に、徐放性を有するゲル状組成物としては、特開平6−256221号公報に、アルギン酸、塩基性多糖類及び複合酸性ムコ多糖類からなるものが記載されているが、アルギン酸をカルシウムイオンで固化して製するゲルは、アルギン酸とカルシウムイオンの反応が速く、所望の形に成形したり、均質なゲルを得ることが困難であった。
【0006】
なお、食品や医薬品で使用実績があり、安全性の確認されているゲルとして、カラギーナンあるいはジェランガムを有機酸カルシウムで固化させて製するゲルが知られているが、これらは離水し易いためゲルの安定性に問題があり、同じくキサンタンガム及びローカストビーンガムからなるゲルでは、離水はしないものの薬物の溶出が極めて遅いという欠点があった。
【0007】
【発明が解決しようとする課題】
本発明の目的は、服用性に優れ、成形容易であり、かつ、薬物の溶出を制御できる徐放性組成物を提供することにある。
【0008】
【課題を解決するための手段】
本発明者らは、種々検討を重ねた結果、数種のゲル基剤を組み合わせ、これに内服可能な医薬品成分を配合し、ゲル状に成形したものが、かかる課題を解決することを見出し、本発明を完成するに至った。
【0009】
すなわち、本発明は、(A)経口投与可能な医薬品成分、(B)カラギーナン及びジェランガムからなる群より選ばれる1種又は2種、(C)キサンタンガム及びローカストビーンガムからなるゲル化剤、並びに(D)有機酸カルシウムを配合したことを特徴とするゲル状徐放性組成物である。
【0010】
【発明の実施の形態】
本発明において経口投与可能な医薬品成分とは、経口投与により効果を発現する医薬品であり、特に水に対する溶解度が5μg/ml(37℃)以上のものが好ましい。具体的にはアセトアミノフェン、塩酸ロペラミド、ピコスルファートナトリウム、イブプロフェン、塩酸ブロムヘキシン、テオフィリン、マレイン酸クロルフェニラミン、インドメタシン、ビタミン類、生薬エキス、シメチジン、塩酸ラニチジン、クラリスロマイシンなどが挙げられる。
【0011】
本発明に用いられるカラギーナン及びジェランガムからなる群より選ばれる1種又は2種は、製剤全体の0.01〜20重量部、好ましくは0.5〜10重量部配合する。また、キサンタンガムおよびローカストビーンガムは、それぞれ0.01〜20重量部、好ましくは0.2〜10重量部であり、キサンタンガムとローカストビーンガムの重量比が1:1〜1:2の範囲内にある。
【0012】
本発明における有機酸カルシウム塩として好ましいものは、乳酸カルシウム、グルコン酸カルシウムなどを挙げることができる。有機酸カルシウムの配合量は製剤全体の0.01〜10重量部、好ましくは0.2〜10重量部である。
【0013】
本発明には添加物として、医薬品として受容可能な甘味剤、矯味剤、香料、乳化剤、安定化剤、充填剤、防腐剤などを配合することができる。例えば、ショ糖、果糖などの糖類、キシリトール、ソルビトールなどの糖アルコール、ステビオシド、ソーマチンなどの甘味料、クエン酸、ココア末などの矯味剤、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンソルビタン脂肪酸エステルなどの界面活性剤、メチルパラベン、エチルパラベン、プロピルパラベン、ブチルパラベンなどの防腐剤、EDTAナトリウム(エチレンジアミン四酢酸二ナトリウム)、エリソルビン酸、BHT(ジブチルヒドロキシトルエン)などの安定化剤、二酸化ケイ素、例えばエロジール200(商品名)などの充填剤などが挙げられる。またこれら添加物以外にも、必要に応じて、通常の医薬品に配合が許される添加物を使用できる。
【0014】
本発明に係るゲル状徐放性組成物は、水にカラギーナン及びジェランガムからなる群より選ばれる1種又は2種とローカストビーンガムを溶解させてなる溶液と経口投与可能な医薬品成分、キサンタンガム及び有機酸カルシウム等を溶解させてなる溶液とを加温して混合させた後、経口容易な大きさ及び形状となるように適当な容器中に充填して冷却固化することにより得ることができる。
【0015】
【発明の効果】
本発明に係るゲルは、数種のゲル基剤を組み合わせることで、それぞれのゲル基剤に固有の欠点を相殺し、離水や溶出性の問題を解決したものであり、比較的融点が高いため保存性に優れるとともに、その製造工程において比較的緩慢に固化するため、服用性あるいは携行性等を考慮した所望の形に成形することができるという特徴を有する。
【0016】
そして、このゲルに経口投与可能な医薬品成分を配合することにより、水なしでも容易に服用することができる医薬品の提供が可能となった。
【0017】
また、このゲルは酸性域において収縮するという性質を有するため、これに医薬品成分を配合した本発明に係るゲル状組成物は、胃の中で収縮することによって内包する薬物を放出し、薬理効果を持続するという徐放効果を発揮することができる。
【0018】
更に、単独のゲル基剤を用いた場合と異なり、ゲル基剤の配合比を変えることで薬物の放出パターンを自在に制御することができるため、薬物の性質や期待される薬理効果に応じた医薬品の提供も可能となった。
【0019】
すなわち、本発明により、服用性に優れ、成形容易であり、かつ、徐放効果を有する医薬品の提供が可能となった。
【0020】
【実施例】
以下、本発明の実施例を記載する。
【0021】
実施例1
クエン酸ナトリウム0.4gを水32.28gに溶解させ、これにカラギーナン1g、ローカストビーンガム0.3gを加えて60℃以上に加温、溶解させてA液とした。
【0022】
キサンタンガム0.3g、塩酸ロペラミド0.1g、クエン酸0.1g、プロピルパラベン0.02g、乳酸カルシウム0.5gをキシリット25gと共に混合し、この粉体混合物を水40gに加え、室温で30分間以上撹拌した後、60℃以上に加温してB液とした。
【0023】
A液とB液を60℃以上の温度を保ったまま、気泡を抜くため減圧下に混合した。これを直径13mm、深さ12mmの円柱形状の容器に高さ10mmとなるように充填し、30℃以下に冷却成形固化して目的のゲル状徐放性組成物を得た。
【0024】
実施例2
表1に記載した成分について実施例1と同様の方法でゲルを調製した。
【0025】
実施例3
表1に記載した成分について実施例1と同様の方法でゲルを調製した。
【0026】
実施例4
表1に記載した成分について実施例1と同様の方法でゲルを調製した。
【0027】
比較例1
ゼラチン5g、塩酸ロペラミド0.1gを予め65〜70℃に加温したグリセリン/水混合溶液(75:19.9)に温度を一定に保ちながら溶解させ、実施例1と同様の容器に充填した。充填後直ちに5℃に冷却し、目的とするゲルを得た。
比較例2
表1に記載した成分について比較例1と同様の方法でゲルを調整した。
【0028】
【表1】
【0029】
試験例
実施例1乃至4、比較例1及び2の薬物の溶出性を日本薬局方第13改正記載の溶出試験法(パドル法)に従って評価した。尚、溶出液には同じく日本薬局方に定める第1及び2液を用い、パドルの回転速度は50rpmを採用した。
【0030】
塩酸ロペラミドの定量には高速液体クロマトグラフィー法(使用機器:日立L7000)を用いた。具体的には、所要時間毎に採取した溶出液中の塩酸ロペラミドの濃度を高速液体クロマトグラフィー(HPLC)を用いて、以下の条件に従い定量した。
【0031】
(1)カラム ;ODS−80Ts(東ソー(株))、φ4×150mm
(2)カラム温度;50℃
(3)移動相 ;メタノール(600):水(400):アセトニトリル (50):1−ペンタンスルホン酸ナトリウム(1):リン酸(1)(括弧内の数字は、1−ペンタンスルホン酸ナトリウムについては重量比、それ以外については体積比を表す)
(4)流速 ;1ml/min
(5)試料注入量;10μg
(6)検出 ;UV(210nm)
結果を図1及び2に示す。
【図面の簡単な説明】
【図1】日本薬局方第1及び2液における実施例2で調製したゲルからの塩酸ロペラミドの溶出を示すグラフである。
【図2】酸性条件(日本薬局方第1液)下において実施例1乃至4、比較例1及び2で調製したゲルからの塩酸ロペラミドの溶出を示すグラフである。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a sustained release composition. More particularly, the present invention relates to a sustained-release composition having an action that it can be easily taken without water and can maintain a pharmacological effect by controlling the elution of the drug because it exhibits a gel-like shape.
[0002]
[Prior art]
Conventionally, in order to produce a sustained-release preparation, a method of controlling the elution time of a drug by coating a spherical granulated core particle containing a drug with a film coating and changing its film thickness has been used. Recently, a method of giving a sustained release function to the coating substance itself without changing the coating thickness, or forming a matrix structure of a drug and a release controlling substance at the time of spherical granulation has been used. The drug thus obtained is provided as a sustained-release preparation in the form as it is, as a granule or powder, or encapsulated in a capsule or contained in a tablet.
[0003]
However, these usually require a lot of time and labor since they undergo complicated manufacturing processes, and are difficult to take because they are solid, and may be difficult to take, especially for elderly people and children with low swallowing ability. Also, since water and hot water are required when taking, it was not of a nature that can be taken anywhere anytime.
[0004]
Here, JP-A-56-97220 describes preparations focusing on the ingestion, such as those obtained by gelling water-soluble drugs with agar or gelatin. However, it was not intended for drug elution control. In addition, Kanten is easy to release water, so that it is difficult to ensure the stability of the gel, and gelatin cannot control the elution of the drug.
[0005]
Furthermore, as a gel composition having sustained release properties, JP-A-6-256221 discloses a composition comprising alginic acid, a basic polysaccharide and a complex acidic mucopolysaccharide. The gel produced by solidification has a fast reaction between alginic acid and calcium ions, and it has been difficult to form a desired shape or obtain a homogeneous gel.
[0006]
As gels that have been used in foods and pharmaceuticals and have been confirmed to be safe, gels made by solidifying carrageenan or gellan gum with organic acid calcium are known. There was a problem in stability, and the gel consisting of xanthan gum and locust bean gum had the disadvantage that the dissolution of the drug was extremely slow although it was not separated.
[0007]
[Problems to be solved by the invention]
An object of the present invention is to provide a sustained-release composition that is excellent in dosage, easy to mold, and can control drug elution.
[0008]
[Means for Solving the Problems]
As a result of various investigations, the present inventors have found that a combination of several gel bases, a medicinal component that can be used internally, and a gel-like composition solve this problem, The present invention has been completed.
[0009]
That is, the present invention includes (A) an orally administrable pharmaceutical ingredient, (B) one or two selected from the group consisting of carrageenan and gellan gum, (C) a gelling agent composed of xanthan gum and locust bean gum, and ( D) A gel-like sustained-release composition characterized by containing calcium organic acid.
[0010]
DETAILED DESCRIPTION OF THE INVENTION
The pharmaceutical ingredient that can be administered orally in the present invention is a pharmaceutical that exhibits an effect by oral administration, and particularly preferably has a solubility in water of 5 μg / ml (37 ° C.) or more. Specific examples include acetaminophen, loperamide hydrochloride, picosulfate sodium, ibuprofen, bromhexine hydrochloride, theophylline, chlorpheniramine maleate, indomethacin, vitamins, herbal extracts, cimetidine, ranitidine hydrochloride, clarithromycin and the like.
[0011]
1 type or 2 types chosen from the group which consists of carrageenan and gellan gum used for this invention mix | blend 0.01-20 weight part of the whole preparation, Preferably 0.5-10 weight part is mix | blended. Xanthan gum and locust bean gum are each 0.01 to 20 parts by weight, preferably 0.2 to 10 parts by weight, and the weight ratio of xanthan gum and locust bean gum is within the range of 1: 1 to 1: 2. is there.
[0012]
Preferred examples of the organic acid calcium salt in the present invention include calcium lactate and calcium gluconate. The compounding quantity of organic acid calcium is 0.01-10 weight part of the whole preparation, Preferably it is 0.2-10 weight part.
[0013]
In the present invention, sweeteners, flavoring agents, fragrances, emulsifiers, stabilizers, fillers, preservatives and the like that are acceptable as pharmaceuticals can be added as additives. For example, sugars such as sucrose and fructose, sugar alcohols such as xylitol and sorbitol, sweeteners such as stevioside and thaumatin, flavoring agents such as citric acid and cocoa powder, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid ester, etc. Surfactants such as methylparaben, ethylparaben, propylparaben, butylparaben, etc., stabilizers such as sodium EDTA (disodium ethylenediaminetetraacetate), erythorbic acid, BHT (dibutylhydroxytoluene), silicon dioxide such as ethyl 200 (trade name) and the like. In addition to these additives, additives that can be blended into ordinary pharmaceuticals can be used as necessary.
[0014]
The gel-like sustained-release composition according to the present invention comprises a solution obtained by dissolving locust bean gum and one or two selected from the group consisting of carrageenan and gellan gum in water, an orally administrable pharmaceutical ingredient, xanthan gum and organic It can be obtained by heating and mixing a solution in which calcium acid or the like is dissolved, and then filling in a suitable container so that it can be easily sized and shaped and cooled and solidified.
[0015]
【The invention's effect】
The gel according to the present invention is a combination of several types of gel bases, which offsets the disadvantages inherent in each gel base and solves the problem of water separation and elution, and has a relatively high melting point. In addition to being excellent in storability, it is solidified relatively slowly in the production process, and thus has a feature that it can be formed into a desired shape in consideration of the ingestibility or portability.
[0016]
Then, by incorporating a medicinal component that can be administered orally into this gel, it has become possible to provide a medicinal product that can be easily taken without water.
[0017]
In addition, since this gel has the property of contracting in the acidic region, the gel composition according to the present invention, in which a pharmaceutical ingredient is blended with it, releases the drug contained by contracting in the stomach and has a pharmacological effect. The sustained release effect of sustaining can be exhibited.
[0018]
Furthermore, unlike the case where a single gel base is used, the release pattern of the drug can be freely controlled by changing the blending ratio of the gel base, so that it corresponds to the nature of the drug and the expected pharmacological effect. The provision of pharmaceuticals has become possible.
[0019]
That is, according to the present invention, it has become possible to provide a medicinal product that is excellent in dosage, easy to mold, and has a sustained release effect.
[0020]
【Example】
Examples of the present invention will be described below.
[0021]
Example 1
0.4 g of sodium citrate was dissolved in 32.28 g of water, 1 g of carrageenan and 0.3 g of locust bean gum were added thereto, and the mixture was heated to 60 ° C. or higher to dissolve it to prepare a solution A.
[0022]
Xanthan gum 0.3g, loperamide hydrochloride 0.1g, citric acid 0.1g, propylparaben 0.02g, calcium lactate 0.5g was mixed with 25g xylit, this powder mixture was added to water 40g, and at room temperature for 30 minutes or more After stirring, the mixture was heated to 60 ° C. or higher to obtain a liquid B.
[0023]
Liquid A and Liquid B were mixed under reduced pressure to remove bubbles while maintaining a temperature of 60 ° C. or higher. This was filled into a cylindrical container having a diameter of 13 mm and a depth of 12 mm so as to have a height of 10 mm, and cooled and solidified to 30 ° C. or lower to obtain a desired gel-like sustained release composition.
[0024]
Example 2
Gels were prepared in the same manner as in Example 1 for the components listed in Table 1.
[0025]
Example 3
Gels were prepared in the same manner as in Example 1 for the components listed in Table 1.
[0026]
Example 4
Gels were prepared in the same manner as in Example 1 for the components listed in Table 1.
[0027]
Comparative Example 1
5 g of gelatin and 0.1 g of loperamide hydrochloride were dissolved in a glycerin / water mixed solution (75: 19.9) previously heated to 65 to 70 ° C. while keeping the temperature constant, and filled in the same container as in Example 1. . Immediately after filling, it was cooled to 5 ° C. to obtain the intended gel.
Comparative Example 2
Gels were prepared in the same manner as in Comparative Example 1 for the components listed in Table 1.
[0028]
[Table 1]
[0029]
Test Examples The dissolution properties of the drugs of Examples 1 to 4 and Comparative Examples 1 and 2 were evaluated according to the dissolution test method (paddle method) described in the Japanese Pharmacopoeia 13th revision. In addition, the 1st and 2nd liquid similarly defined in Japanese Pharmacopoeia was used for the eluate, and the rotational speed of the paddle was 50 rpm.
[0030]
For the determination of loperamide hydrochloride, a high performance liquid chromatography method (device used: Hitachi L7000) was used. Specifically, the concentration of loperamide hydrochloride in the eluate collected every required time was quantified using high performance liquid chromatography (HPLC) according to the following conditions.
[0031]
(1) Column: ODS-80Ts (Tosoh Corporation), φ4 × 150 mm
(2) Column temperature: 50 ° C
(3) Mobile phase: Methanol (600): Water (400): Acetonitrile (50): Sodium 1-pentanesulfonate (1): Phosphoric acid (1) (The numbers in parentheses are for 1-pentanesulfonate sodium. Is the weight ratio, otherwise it represents the volume ratio)
(4) Flow rate: 1 ml / min
(5) Sample injection amount: 10 μg
(6) Detection: UV (210 nm)
The results are shown in FIGS.
[Brief description of the drawings]
FIG. 1 is a graph showing elution of loperamide hydrochloride from the gel prepared in Example 2 in the first and second liquids of the Japanese Pharmacopoeia.
FIG. 2 is a graph showing elution of loperamide hydrochloride from the gels prepared in Examples 1 to 4 and Comparative Examples 1 and 2 under acidic conditions (Japanese Pharmacopoeia First Solution).
Claims (2)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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JP04089897A JP3774975B2 (en) | 1997-02-25 | 1997-02-25 | Gel-like sustained release composition |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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JP04089897A JP3774975B2 (en) | 1997-02-25 | 1997-02-25 | Gel-like sustained release composition |
Publications (2)
Publication Number | Publication Date |
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JPH10236983A JPH10236983A (en) | 1998-09-08 |
JP3774975B2 true JP3774975B2 (en) | 2006-05-17 |
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JP04089897A Expired - Fee Related JP3774975B2 (en) | 1997-02-25 | 1997-02-25 | Gel-like sustained release composition |
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Families Citing this family (15)
Publication number | Priority date | Publication date | Assignee | Title |
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EP1027072A1 (en) * | 1997-10-31 | 2000-08-16 | Monsanto Company | Controlled release compositions comprising gellan gum gels |
WO2001002477A1 (en) * | 1999-07-06 | 2001-01-11 | The Procter & Gamble Company | Pre-formed, self-adhesive sheets suitable for topical application |
AU762291B2 (en) * | 1999-09-30 | 2003-06-19 | Penwest Pharmaceutical Co. | Sustained release matrix systems for highly soluble drugs |
JP5241978B2 (en) * | 1999-10-13 | 2013-07-17 | 帝國製薬株式会社 | Kampo jelly pharmaceutical composition |
AU2001241060A1 (en) * | 2000-03-10 | 2001-09-17 | Taisho Pharmaceutical Co. Ltd. | Gel preparations for oral administration having improved preservation properties |
JPWO2002064120A1 (en) * | 2001-02-13 | 2004-06-10 | 大正製薬株式会社 | Oral gel preparation |
JP3978357B2 (en) * | 2002-03-19 | 2007-09-19 | 小林製薬株式会社 | Aqueous gel composition and aqueous gel sheet |
JP3978356B2 (en) * | 2002-03-19 | 2007-09-19 | 小林製薬株式会社 | Aqueous gel composition and aqueous gel sheet |
JP5153045B2 (en) * | 2002-07-29 | 2013-02-27 | 帝國製薬株式会社 | Kampo jelly pharmaceutical composition |
US20060177497A1 (en) * | 2003-07-21 | 2006-08-10 | Bio Dar Ltd. | Gellan gum based oral controlled release dosage forms-a novel platform technology for gastric retention |
JP4771044B2 (en) * | 2004-09-15 | 2011-09-14 | 大正製薬株式会社 | Mucosal fluid |
JP4953673B2 (en) * | 2006-03-22 | 2012-06-13 | リンテック株式会社 | Oral administration |
WO2007117605A2 (en) * | 2006-04-06 | 2007-10-18 | Taro Pharmaceuticals North America, Inc. | Novel spill-resistant formulations comprising hydrocolloidal polymers |
JP2011068606A (en) * | 2009-09-25 | 2011-04-07 | Kumamoto Univ | Sustained-release carrier, drug using the sustained-release carrier and drug delivery system using the drug |
JP7459458B2 (en) * | 2018-06-28 | 2024-04-02 | ライオン株式会社 | Oral composition and its manufacturing method |
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1997
- 1997-02-25 JP JP04089897A patent/JP3774975B2/en not_active Expired - Fee Related
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