KR950031044A - Soft tablet composed of the outer shell and inner core and its manufacturing method - Google Patents

Soft tablet composed of the outer shell and inner core and its manufacturing method Download PDF

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Publication number
KR950031044A
KR950031044A KR1019940014912A KR19940014912A KR950031044A KR 950031044 A KR950031044 A KR 950031044A KR 1019940014912 A KR1019940014912 A KR 1019940014912A KR 19940014912 A KR19940014912 A KR 19940014912A KR 950031044 A KR950031044 A KR 950031044A
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KR
South Korea
Prior art keywords
soft
solution
inner core
drug
tablet according
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KR1019940014912A
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Korean (ko)
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KR0132535B1 (en
Inventor
이동원
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이용원
주식회사 새한제약
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Publication of KR950031044A publication Critical patent/KR950031044A/en
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Publication of KR0132535B1 publication Critical patent/KR0132535B1/en

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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2873—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

본 발명은 연질정제 및 그의 제조방법에 관한 것이다. 특히 본 발명은 기준의 통상적인 경구투여용 제형의 단점을 해소시키면서 경구투여의 잇점을 최대로 살려 복용이 용이하고 투약 순응도가 우수할 뿐 아니라 제형으로 부터의 약물의 휘발이나 인습성을 방지한 연질정제 및 그의 제조방법에 관한 것이다. 본 발명에 따른 연질정제는 활성약물을 함유하는 내부코어를 젤라틴을 주성분으로 하는 연질 외피용액과 함께 압출성형시키거나, 피복시킴으로써 제조된다.The present invention relates to a soft tablet and a method for producing the same. In particular, the present invention is easy to take advantage of the advantages of oral administration while eliminating the disadvantages of the standard oral dosage form of the standard, easy to take, excellent in compliance with the dosage as well as soft to prevent the volatilization of the drug from the formulation A tablet and a method for producing the same. The soft tablet according to the present invention is prepared by extruding or coating the inner core containing the active drug with a soft skin solution containing gelatin as a main component.

Description

외피와 내부코어로 구성된 연질정제 및 그의 제조방법Soft tablet composed of the outer shell and inner core and its manufacturing method

본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음Since this is an open matter, no full text was included.

Claims (13)

활성성분을 함유하는 내부코어 및 연질 외피로 구성됨을 특징으로 하는 연질정체.Soft body, characterized in that consisting of an inner core and a soft outer shell containing the active ingredient. 제1항에 있어서, 활성약물이 해열진통제, 소염진통제, 소화기계용 약물, 호흡기계용 약물, 비타민제, 호르몬제, 멀미약, 구취제거제, 칼슘 보급제, 변비약 또는 피로 회복제인 연질정제.The soft tablet according to claim 1, wherein the active drug is antipyretic analgesic, anti-inflammatory analgesic, digestive system drug, respiratory drug, vitamin, hormone, motion sickness medicine, bad breath remover, calcium supplement, constipation drug or fatigue recovery agent. 제2항에 있어서, 활성약물이 아세트아미노펜임을 특징으로 하는 연질정제.The soft tablet according to claim 2, wherein the active drug is acetaminophen. 제2항에 있어서, 활성약물이 돔페리돈임을 특징으로 하는 연질정제.The soft tablet according to claim 2, wherein the active drug is domperidone. 제2항에 있어서, 활성약물이 DL-페닐알라닌과 D-로이신임을 특징으로 하는 연질정제.The soft tablet according to claim 2, wherein the active drugs are DL-phenylalanine and D-leucine. 제1항에 있어서, 활성약물이 추가로 연질 외피중에도 존재하는 연질정제.The soft tablet according to claim 1, wherein the active drug is further present in the soft shell. 제6항에 있어서, 활성약물이 비휘발성 약물인 연질정제.The soft tablet according to claim 6, wherein the active drug is a nonvolatile drug. 제1항에 있어서, 외피가 젤라틴을 주성분으로 하는 용액인 연질정제The soft tablet according to claim 1, wherein the outer shell is a solution composed mainly of gelatin. a)펙틴을 당 용액과 혼합시키고, 생성된 혼합물을 물에 가하고, 계속해서 약제학적 분야에서 통상적인 시럽제를 가한 후에 가온하여 성분들을 완전히 용해시키고, 생성된 용액에 당을 추가하여 용해시킨 후에 계속해서 가온하여 농축시키고, 냉각시키고 완충용액을 가한 후에 생성된 코아 용액에 활성약물을 교반하면서 가하여 균질화시켜 내부코어 용액을 제조하고; b) ⅰ)젤라틴에 물을 가하여 침적시킨 후에 수욕중에 팽윤시키고 건조시키고, ⅱ)별도의 용기에 물, 솔비톨 시럽, 콘 시럽 및 당을 가하여 가열하에 교반하여 농축시키고, ⅲ)생성된 액을 냉각시킨 후, 여기에 상기 b-ⅰ)에서 제조된 젤라틴 액을 교반하면서 가하여 혼합시키고, ⅳ)생성된 혼합쿨에 시트르산, 물 및 과즙의 혼합물을 가하여 혼합시키고, 계속해서 물, 펙틴 및 당의 교반 및 가온된 혼합물을 가하여 혼합시켜 외피용 용액을 제조하고, c) 상기 단계 b)에서 생성된 외피용 용액을 단계 a)에서 제조된 내부코어와 함께 주형에 넣어 정제의 형태로 성형시키거나, 내부 코어를 외피용 용액으로 피복시킴을 특징으로 하여 연질정제를 제조하는 방법.a) the pectin is mixed with the sugar solution, the resulting mixture is added to water, followed by the addition of syrups customary in the pharmaceutical field, followed by warming to completely dissolve the components, and the addition of sugar to the resulting solution to continue dissolution Warming and concentrating, cooling and adding a buffer solution, and then homogenizing the active drug by stirring the resultant core solution to prepare an inner core solution; b) iv) gelatin is added to water to deposit, swelled and dried in water bath, ii) water, sorbitol syrup, corn syrup and sugar are added to a separate container, stirred and concentrated under heating, and iii) the resulting liquid is cooled. After mixing, the gelatine liquid prepared in b-iii) was added to the mixture while stirring, and iii) a mixture of citric acid, water, and juice was added to the resulting mixture, followed by mixing, followed by stirring of water, pectin and sugar and The heated mixture is added to form a shell solution, and c) the shell solution produced in step b) is placed in a mold together with the inner core prepared in step a) to form a tablet or an inner core. Method for producing a soft tablet, characterized in that the coating with a coating solution. 제9항에 있어서, 내부코어중의 활성성분과 코어용액의 중량비가 1 : 0.1-10임을 특징으로 하는 방법.10. The method according to claim 9, wherein the weight ratio of the active ingredient in the inner core to the core solution is 1: 0.1-10. 제9항에 있어서, 내부코어와 외피의 구성비가 1 : 0.5-10임을 특징으로 하는 방법.10. The method of claim 9, wherein the ratio of the inner core and the shell is 1: 0.5-10. 제9항에 있어서, 단계 a)에서 사용된 시럽제가 솔비톨 시럽 및 시럽임을 특징으로 하는 방법.10. The method of claim 9, wherein the syrup used in step a) is sorbitol syrup and syrup. 제9항에 있어서, 단계 b)-ⅳ)에서 생성된 외피 용액을 내부코어와 함께 성형시키기 전에 활성약물을 혼합시킴을 특징으로 하는 방법.10. The method according to claim 9, characterized in that the active agent is mixed before molding the shell solution produced in steps b) -iii) together with the inner core. ※ 참고사항 : 최초출원 내용에 의하여 공개되는 것임.※ Note: This is to be disclosed by the original application.
KR1019940014912A 1994-05-10 1994-06-27 Process for preparing soft tablet consisting of outer shell and inner core KR0132535B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR19940010238 1994-05-10
KR94-10238 1994-05-10

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KR950031044A true KR950031044A (en) 1995-12-18
KR0132535B1 KR0132535B1 (en) 1998-04-17

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100443722B1 (en) * 2002-09-26 2004-08-09 이용원 Hard chewing candy comprising nicotine and its preparation

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100443722B1 (en) * 2002-09-26 2004-08-09 이용원 Hard chewing candy comprising nicotine and its preparation

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KR0132535B1 (en) 1998-04-17

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