EP1587501A1 - Einfache tablettierung unter verwendung von gelatine - Google Patents

Einfache tablettierung unter verwendung von gelatine

Info

Publication number
EP1587501A1
EP1587501A1 EP03707641A EP03707641A EP1587501A1 EP 1587501 A1 EP1587501 A1 EP 1587501A1 EP 03707641 A EP03707641 A EP 03707641A EP 03707641 A EP03707641 A EP 03707641A EP 1587501 A1 EP1587501 A1 EP 1587501A1
Authority
EP
European Patent Office
Prior art keywords
tablet
gelatin
powder
disintegrator
diluent
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.)
Withdrawn
Application number
EP03707641A
Other languages
English (en)
French (fr)
Other versions
EP1587501A4 (de
Inventor
Minh Nguyen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP1587501A1 publication Critical patent/EP1587501A1/de
Publication of EP1587501A4 publication Critical patent/EP1587501A4/de
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2063—Proteins, e.g. gelatin

Definitions

  • This invention relates to tablet preparations.
  • a tablet basically contains: (1) diluent, (2) binder, (3) disintegrator, and (4) lubricant.
  • Diluent is a substance or a mixture of substances added to a tablet to increase the bulk in order to make the tablet a practical size for compression.
  • Binder is a substance or a mixture of substances added to a tablet to impart a cohesiveness to the tablet formulation which insures the tablet remaining intact after compression.
  • Disintegrator is a substance or a mixture of substances added to a tablet to facilitate its breakup or disintegration after administration.
  • Lubricant is a substance or a mixture of substances added to a tablet to improve the flowability and to prevent adhesion of the tablet material to the surface of the dies and punches, reduce interparticle friction, and facilitate the ejection of the tablets from the die cavity.
  • wet-granulation method is the most widely used method. Its popularity is due to the greater probability that the granulation will meet all the physical requirements for the compression of good tablets. Its chief disadvantages are the number of separate steps involved and the time and labor necessary to carry out the procedure.
  • the steps involved in the wet-granulation method are: (1) weighing, (2) mixing, (3) granulation, (4) screening the damp mass after granulation, (5) drying (6) dry screening (7) lubrication, and (8) compression.
  • Dry-granulation method is generally used when tablet ingredients are sensitive to moisture or are unable to withstand elevated temperatures during drying. This method eliminates a number of steps but still includes (1) weighing, (2) mixing, (3) dry granulation, (4) dry screening, (5) lubrication, and (6) compression. However, this method requires that the tablet ingredients must have sufficient inherent binding or cohesive properties for dry granulation.
  • Direct compression consists of compressing tablets directly from ingredients without wet or dry granulation. This method comprises only three steps: (1) weighing, (2) mixing, and (3) compression.
  • the active ingredients must possess inherent binding and cohesive properties, and/or (2) the diluents and/or binders must be capable of imparting the compressible characteristics.
  • the ingredients must be subjected to preprocessing step such as wet granulation, dry granulation, or other granulation processes such as spheronization, spray drying, and crystallization.
  • the present invention discloses a new method of tablet preparation which is very simple and cost effective.
  • the method of the present invention consists of compressing tablets directly from powdered materials without modifying the physical nature of the materials using gelatin. All ingredients used in this method do not have to undergo preprocessing step such as wet granulation, dry granulation, or other granulation processes such as spheronization, spray drying, and crystallization.
  • aqueous solution of gelatin has often been used in wet granulation. However, its dry form, powder or granules, has never been directly used in tablet compression .
  • the method of tablet preparation in this invention comprises only three simple steps: (1) weighing, (2) mixing, and (3) compression.
  • Gelatin used in this invention can be powder or granules and in concentrations from 0.1% to 99.9% of the tablet weight.
  • STEP 1- WEIGHING Active ingredient(s), gelatin, and other ingredient(s) are accurately weighed.
  • STEP 2- MIXING Active ingredient(s), gelatin, and other ingredient(s) are added, one item at a time, into a suitable blender and mix for an appropriate length of time.
  • STEP 3- COMPRESSION The mixture from STEP 2 is compressed into tablets.
  • the following examples of method of preparing tablets using gelatin at different concentrations are given. It is understood that these examples are considered as illustrative only and are not to be construed as limitations on the present invention.
  • EXAMPLFi I Gelatin is used as diluent, binder, and disintegrator
  • Vitamin B 12 powder (active ingredient) 0.006 mg/tablet
  • methenamine naturally possesses cohesive property which makes compression without binders possible. However, if gelatin is absent, the disintegration would take longer than 30 minutes.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
EP03707641A 2003-01-03 2003-01-03 Einfache tablettierung unter verwendung von gelatine Withdrawn EP1587501A4 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2003/002945 WO2004062647A1 (en) 2003-01-03 2003-01-03 Simple tablet compression using gelatin

Publications (2)

Publication Number Publication Date
EP1587501A1 true EP1587501A1 (de) 2005-10-26
EP1587501A4 EP1587501A4 (de) 2007-04-11

Family

ID=32710277

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03707641A Withdrawn EP1587501A4 (de) 2003-01-03 2003-01-03 Einfache tablettierung unter verwendung von gelatine

Country Status (4)

Country Link
EP (1) EP1587501A4 (de)
AU (1) AU2003208918A1 (de)
CA (1) CA2477221A1 (de)
WO (1) WO2004062647A1 (de)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4140192A1 (de) * 1991-12-05 1993-06-09 Alfatec-Pharma Gmbh, 6900 Heidelberg, De Sol-gesteuerte thermokolloidmatrix auf gelatinebasis fuer perorale retardformen
US5958455A (en) * 1996-02-09 1999-09-28 Quadrant Holdings Cambridge Ltd Oral solid dosage forms, methods of making same and compositions thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ302926A (en) * 1995-02-28 1998-10-28 Hoechst Marion Roussel Inc Composition for use as antihistamines comprising piperidinoalkanol derivatives and inert ingredients

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4140192A1 (de) * 1991-12-05 1993-06-09 Alfatec-Pharma Gmbh, 6900 Heidelberg, De Sol-gesteuerte thermokolloidmatrix auf gelatinebasis fuer perorale retardformen
US5958455A (en) * 1996-02-09 1999-09-28 Quadrant Holdings Cambridge Ltd Oral solid dosage forms, methods of making same and compositions thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2004062647A1 *

Also Published As

Publication number Publication date
WO2004062647A1 (en) 2004-07-29
AU2003208918A1 (en) 2004-08-10
EP1587501A4 (de) 2007-04-11
CA2477221A1 (en) 2004-07-29

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