JPS6092214A - Composition for filling soft capsule - Google Patents
Composition for filling soft capsuleInfo
- Publication number
- JPS6092214A JPS6092214A JP20042783A JP20042783A JPS6092214A JP S6092214 A JPS6092214 A JP S6092214A JP 20042783 A JP20042783 A JP 20042783A JP 20042783 A JP20042783 A JP 20042783A JP S6092214 A JPS6092214 A JP S6092214A
- Authority
- JP
- Japan
- Prior art keywords
- acetaminophen
- composition
- filling
- macrogol
- dispersing
- 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
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
【発明の詳細な説明】
本発明は軟カプセル充填用組成物、更に詳細には、アセ
トアミノフェン又はアセトアミノフェン配合薬剤の軟カ
プセル充填用組成物に関する。DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a composition for filling soft capsules, and more particularly to a composition for filling soft capsules of acetaminophen or acetaminophen-containing drugs.
アセトアミノフェンは発熱を伴う感冒、炎症性扶患の解
熱剤として、また頭痛、生理痛、筋肉痛尋の鎮痛剤とし
て、単独あるいは他の医薬品と併用して使用されている
。Acetaminophen is used alone or in combination with other medicines as an antipyretic for colds accompanied by fever and inflammatory disorders, and as an analgesic for headaches, menstrual pain, and muscle pain.
しかしながら、アセトアミノフェンは斯かる目的で使用
する場合、通常１回の服用量が１５０〜３００１ｑと多
く、シかも一般に使用されている軟カプセル用基剤に溶
解し難いため、これを従来一般に使用されている油脂又
は液状脂肪酸類等の基剤に分散させて流動性のある軟カ
プセル用充填剤を得ようとすると、アセトアミノフェン
ｌ′Ｎ量部に対し基剤を１．５〜２．５１ｊＬ量部使用
しなけれはガらないが、斯くするとカプセルが大型とな
るかあるいは１囲に服用するカプセル数が多くなり、服
用に困難をきたすことを免れ彦かった。However, when acetaminophen is used for such purposes, the amount per dose is usually large (150 to 3001q), and it is difficult to dissolve in the commonly used soft capsule base, so it has not been commonly used in the past. When attempting to obtain a fluid filler for soft capsules by dispersing it in a base such as oil or fat or liquid fatty acids, the proportion of the base to 1 part of acetaminophen N is 1.5 to 2. Although it would not work unless 51jL was used, doing so would result in larger capsules or a larger number of capsules to be taken in one circumference, which would prevent difficulty in taking the drug.
一方、総合感冒剤、解熱剤及び鎮痛剤に使用される他の
成分は、その配合量が少ないかあるいは尚該基剤に溶解
するため、アセトアミノフェンを配合しない場合は軟カ
プセル化が容易である。しかし、アセトアミノフェンは
解熱鎮痛剤として極めて優れているため、上記薬剤に好
んで配合されるが、一方ではこれが尚該薬剤を軟カプセ
ル化する際の隘路となっており、その結果、アセトアミ
ノフェン配合薬剤の軟カプセル製剤は提供されていない
。On the other hand, other ingredients used in general cold remedies, antipyretics, and analgesics are easily encapsulated in soft capsules if acetaminophen is not included, because the amount of these ingredients is small or they are still soluble in the base. . However, since acetaminophen is extremely excellent as an antipyretic and analgesic, it is preferred to be added to the above drugs, but on the other hand, this is still a bottleneck in encapsulating the drug into soft capsules, and as a result, acetaminophen Soft capsule formulations of fen-containing drugs are not available.
本発明者は、斯かる難点を解決すべく鋭意研究の結果、
充填用基剤として特定の水溶性基剤を用いれば、少量で
もアセトアミノフェンを均一に分散でき、充填に適した
流動性を有する軟カプセル充填用組成物が得られること
を見出し本発明を完成した。As a result of intensive research to solve such difficulties, the present inventor has found that
The present invention was completed by discovering that by using a specific water-soluble base as a filling base, acetaminophen can be uniformly dispersed even in small amounts, and a soft capsule filling composition having fluidity suitable for filling can be obtained. did.
すなわち、本発明はアセトアミノフェン又はアセトアミ
ノフェン配合薬剤をマクロゴール又は（及び）７″ロビ
レングリコールに分散せしめた軟力１セル充填用組成物
を提供するものである。That is, the present invention provides a soft one-cell filling composition in which acetaminophen or an acetaminophen-containing drug is dispersed in macrogol or/and 7'' robylene glycol.
本発ＢＡＶｃおいて、アセトアミノフェンに配 ３−
合される他の医薬品としては、通常総合感冒剤、鎮痛剤
、解熱剤等に使用されるものは倒れも使用することがで
き、例えば臭化水素酸デキストロメトルファン、塩酸メ
チルエフェドリン、ヒベンズ酸チペピゾン、リン酸ゾヒ
ドロコデイン勢の鎮咳去痰剤、マレイン酸りロルフェニ
ラミン勢の抗ヒスタミン剤、ビタミンＣ１塩酸チアミン
、リボフラビン等のビタミン剤、その他無水カフェイン
、アリルイソプロピルアセチル尿素等を挙けることがで
きる。In the present BAVc, other medicines that are combined with acetaminophen include those normally used as common cold medicines, analgesics, antipyretics, etc. For example, hydrogen bromide Dextromethorphan acid, methylephedrine hydrochloride, tipepizone hibenzate, antitussive and expectorant agents based on zohydrocodeine phosphate, antihistamines based on lorpheniramine maleate, vitamins such as vitamin C1, thiamine hydrochloride, riboflavin, and other anhydrous caffeine, allyl isopropyl Examples include acetylurea.
アセトアミノフェン又はその配合薬剤は、マクロゴール
又Ｆｉ（及び）プロピレングリコール１重量部に対して
１．５重量部未満まで分散することができるが、特に０
．７〜１．４重量 ４一
部となるように分散させるのが好ましい。Acetaminophen or its combination drug can be dispersed in an amount of less than 1.5 parts by weight per 1 part by weight of macrogol or Fi (and) propylene glycol.
．． It is preferable to disperse it so that the amount is 7 to 1.4 parts by weight.
本発明の軟カプセル充填用組成物は、予め微粉としたア
セトアミノフェン又はその配合薬剤をマクロゴール又は
（及び）テロピレングリコールに分散させるか、又はア
セトアミノフェン又はその配合薬剤をマクロゴール又は
（及び）プロピレングリコール１ｕｌｌ、ｔ、ソの中で
微細化して分散させることにより製造される。斯くして
製造されたアセトアミノフェンの微粉末を含む懸濁液は
軟カプセルに充填するのに適した流動性を有する。The composition for filling soft capsules of the present invention can be prepared by dispersing acetaminophen or a compounded drug thereof into a fine powder in macrogol or (and) teropylene glycol, or by dispersing acetaminophen or a compounded drug thereof in macrogol or (and) acetaminophen or a compounded drug thereof. and) manufactured by micronizing and dispersing in 1 μl, t, or so of propylene glycol. The thus produced suspension containing fine powder of acetaminophen has fluidity suitable for filling into soft capsules.
次に実施例を挙けて本発明を説明する。Next, the present invention will be explained with reference to Examples.
実施例１
予め微粉としたアセトアミノフェンを下記第１表に示す
各種基剤中に分散させて懸濁液を調製し、その流動性を
調べた。その結果を第１表に示す。なお、流動性は、流
動性良好（○）、一応流動性有り（△）、流動性無しく
×）の３段階に評価した。Example 1 Acetaminophen, which was previously made into a fine powder, was dispersed in various bases shown in Table 1 below to prepare a suspension, and its fluidity was examined. The results are shown in Table 1. The fluidity was evaluated in three stages: good fluidity (◯), some fluidity (△), and no fluidity (×).
以下余白
第１表から明らかな如く、一般の油脂、脂肪酸類等を使
用した場合、アセトアミノフェンの配合量は基剤に対し
て０．５〜０．６重量倍で限界であるが、液状のマクロ
ゴール、プロピレングリコール及びこれらの混合物を使
用すること罠より、基剤に対して０，７〜１．４重量倍
のアセトアミノフェンを配合しても流動性のよい懸濁液
が得られる。As is clear from Table 1 below, when using general oils, fats, fatty acids, etc., the maximum amount of acetaminophen added is 0.5 to 0.6 times the weight of the base; By using macrogol, propylene glycol, and a mixture thereof, a suspension with good fluidity can be obtained even if acetaminophen is mixed in an amount of 0.7 to 1.4 times the weight of the base. .
実施例２ 下記組成の軟カプセル充填用組成物を調製した。Example 2 A composition for filling soft capsules having the following composition was prepared.
アセトアミノフェン ９０ （１（ｑ）マレイン酸りｐ
ルフェニラミン ７．５臭化水素酸デキストロメトルフ
アン ４５塩酸メチルエフエドリン ３゜
無水カフェイン ７５
ビタミンｃ １ｏ。Acetaminophen 90 (1(q) maleic acid p
Lupheniramine 7.5 Dextromethorphan hydrobromide 45 Methylphedrin hydrochloride 3° Caffeine anhydrous 75 Vitamin c 1o.
プロピレングリコール ９４２．５ １００ 実施例３ 下記組成の軟カプセル充填用組成物を調製した。Propylene glycol 942.5 100 Example 3 A composition for filling soft capsules having the following composition was prepared.
アセトアミノフェン ９００ （ｍｇ）マレイン販クロ
ルフェニラミン ７．５ヒベンズ酸チペピゾン ７５
ｄｔ−塩酸メチルエフェドリン ６０
無水カフエイン ７５
マクロゴー＃−４００１０４２，５
９−
１６０
実施例４
下記紐取の軟カプセル充填用組成物を調製した。Acetaminophen 900 (mg) Malein Chlorpheniramine 7.5 Tipepizone Hibenzate 75 dt-Methylephedrine Hydrochloride 60 Anhydrous Caffeine 75 Macrogo #-4001042,5 9-160 Example 4 Composition for filling soft capsules with the following string handle was prepared.
アセトアミノフェン ９００（■）
マレイン酸クロルフェニラミン ７．５リン酸ジヒドロ
コデイン １５
ｄｉ−塩酸メチルエフェドリン ３０
無水カフエイン ７５
塩酸チアミン ２４
リボフラビン １２
マクロゴール−３００１０９６，５
１６０
以上
１０−Acetaminophen 900 (■) Chlorpheniramine maleate 7.5 Dihydrocodeine phosphate 15 di-methylephedrine hydrochloride 30 Anhydrous caffein 75 Thiamine hydrochloride 24 Riboflavin 12 Macrogol-3001096,5 160 Above 10-
Claims (1)
薬剤をマクロゴール又は（及び）ゾロぎレンゲリコール
に分散せしめたことを特徴とする軟カプセル充填用組成
物。 ２、 アセトアミノフェン配合薬剤が総合感冑剤、鎮痛
剤又は解熱剤である特許請求の範囲第１項記載の組成物
。 ３、 マクロゴール又は（及び）プロピレングリコール
１１量部にアセトアミノフェン又はアセトアミノフェン
配合薬剤Ｏ２７〜１．４ｉｔ部を分散させたものである
特許請求の範囲第１項又は第２項記載の組成物。[Scope of Claims] 1. A composition for filling soft capsules, characterized in that acetaminophen or an acetaminophen-containing drug is dispersed in macrogol or (and) zorogylene gellicol. 2. The composition according to claim 1, wherein the drug containing acetaminophen is a general sensitizer, an analgesic, or an antipyretic. 3. The composition according to claim 1 or 2, wherein 27 to 1.4 it parts of acetaminophen or an acetaminophen-containing drug is dispersed in 11 parts of macrogol or (and) propylene glycol. thing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP20042783A JPS6092214A (en) | 1983-10-26 | 1983-10-26 | Composition for filling soft capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP20042783A JPS6092214A (en) | 1983-10-26 | 1983-10-26 | Composition for filling soft capsule |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS6092214A true JPS6092214A (en) | 1985-05-23 |
| JPH0465809B2 JPH0465809B2 (en) | 1992-10-21 |
Family
ID=16424115
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP20042783A Granted JPS6092214A (en) | 1983-10-26 | 1983-10-26 | Composition for filling soft capsule |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS6092214A (en) |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5484606A (en) * | 1994-01-24 | 1996-01-16 | The Procter & Gamble Company | Process for reducing the precipitation of difficulty soluble pharmaceutical actives |
| JP2012077072A (en) * | 2010-09-10 | 2012-04-19 | Rohto Pharmaceutical Co Ltd | Liquid pharmaceutical composition and soft capsule containing this |
| US9707184B2 (en) | 2014-07-17 | 2017-07-18 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
| US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US10195153B2 (en) | 2013-08-12 | 2019-02-05 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| US10792254B2 (en) | 2013-12-17 | 2020-10-06 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US10959958B2 (en) | 2014-10-20 | 2021-03-30 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
-
1983
- 1983-10-26 JP JP20042783A patent/JPS6092214A/en active Granted
Non-Patent Citations (5)
| Title |
|---|
| JOURNAL OF PHARMACEUTICAL SCIENCES=1974 * |
| PHARMACEUTICAL TECHNOLOGY=1977 * |
| THE JOURNAL OF CLINICAL PHARMACOLOGY=1974 * |
| THE MERCK INDEX=1976 * |
| THE THEORY AND PRACTICE OF INDUSTRIAL PHARMACY=1970 * |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5484606A (en) * | 1994-01-24 | 1996-01-16 | The Procter & Gamble Company | Process for reducing the precipitation of difficulty soluble pharmaceutical actives |
| JP2012077072A (en) * | 2010-09-10 | 2012-04-19 | Rohto Pharmaceutical Co Ltd | Liquid pharmaceutical composition and soft capsule containing this |
| US10195153B2 (en) | 2013-08-12 | 2019-02-05 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| US10639281B2 (en) | 2013-08-12 | 2020-05-05 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US10792254B2 (en) | 2013-12-17 | 2020-10-06 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US9707184B2 (en) | 2014-07-17 | 2017-07-18 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
| US10959958B2 (en) | 2014-10-20 | 2021-03-30 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0465809B2 (en) | 1992-10-21 |
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