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WO2001010415A1 - A binder for pharmaceutical compositions - Google Patents

A binder for pharmaceutical compositions Download PDF

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Publication number
WO2001010415A1
WO2001010415A1 PCT/IL2000/000412 IL0000412W WO0110415A1 WO 2001010415 A1 WO2001010415 A1 WO 2001010415A1 IL 0000412 W IL0000412 W IL 0000412W WO 0110415 A1 WO0110415 A1 WO 0110415A1
Authority
WO
WIPO (PCT)
Prior art keywords
active ingredient
preparation
echinacea
binder
pharmaceutical composition
Prior art date
Application number
PCT/IL2000/000412
Other languages
French (fr)
Other versions
WO2001010415B1 (en
Inventor
Sigal First
Rina Yamin
Original Assignee
Cts Chemical Industries Ltd.
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 Cts Chemical Industries Ltd. filed Critical Cts Chemical Industries Ltd.
Priority to CA002378987A priority Critical patent/CA2378987C/en
Priority to EP00944197A priority patent/EP1200069A1/en
Priority to AU58428/00A priority patent/AU5842800A/en
Publication of WO2001010415A1 publication Critical patent/WO2001010415A1/en
Publication of WO2001010415B1 publication Critical patent/WO2001010415B1/en

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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1664—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts

Definitions

  • the present invention is generally in the field of pharmaceutics and concerns a pharmaceutical composition comprising an active ingredient and a binder holding together the constituents of the composition.
  • compositions typically consist of at least one active ingredient and several excipients.
  • the excipients may be disintegrants, which assist in releasing the active ingredient under the desired conditions, lubricants, which improve ejection from machine tooling, glidents, which improve flow, binders, which bind together different ingredients of the composition, etc.
  • Binders are of special importance in solid dosage forms, like tablets, pellets, microgranules, and sachets, where they are essential for holding together several different solid ingredients.
  • binders that are in wide use include, for example: starch, starch derivatives, polyvimlpyrolidone (PVP), alginate derivatives, and glucose.
  • PVP polyvimlpyrolidone
  • Echinacea is well known as a food additive, and as such is known to be safe for consumption. It was also proposed as a pharmaceutically active ingredient, and the British Herbal Pharmacopeia (1996) defines it as an immunostimulant. Derwent Abstract No. 012237708 describes a drug that comprises paracetamol, caffeine, Echinacea and several other ingredients for use as an analgesic. Derwent Abstract No. 012234518 describes a cold treatment agent that comprises Echinacea and antipyretic and anti-inflammatory agent. GENERAL DESCRIPTION OF THE INVENTION
  • Echinacea powder or extract of Echinacea is used as a binder in solid pharmaceutiacal compositions, e.g. compositions in the form of tablets, pellets, capsules, microgranules, powders, etc.
  • Echinacea powder or extract (hereiafter Echinacea preparation) may be obtained from Echinacea leafes, roots, or whole plants.
  • Echinacea species that preparations thereof are suitable to serve as binders according to the present invention are those known as Echinacea purpurea, Echinacea angustifolia, Echinacea pallida, Echinacea paradoxa, Echinacea tennesseensis, Echinacea sanguinea, Echinacea simulata and Echinacea atrotubens.
  • Echinacea preparations are Echinacea angustifoliae herba et radix, Echinacea pallidae herba, Echinacea pallidae radix, Echinacea purpureae herba, and Echinacea purpureae redix.
  • the present invention provides, by a first of its aspects, a pharmaceutical composition comprising particulate matter containing at least one pharmaceutically active ingredient and a binder, characterized in that said binder comprises a binding-effective amount o ⁇ Echinacea preparation.
  • binding-effective amount should be understood to denote an amount of Echinacea preparation effective in binding or assisting in binding together components of the composition.
  • the binder may consist of Echinacea preparation or may be a mixture of Echinacea preparation and other ingredients, with the Echinacea preparation having a role in binding the compositions' component together.
  • the property of being included in a binding-effective amount is manifested in that when the Echinacea preparation is removed, the composition's other components will not bind to one another at sufficient strength to hold the composition's components together.
  • the Echinacea preparation will constitute at least about 20% of the binding component of the composition, preferably at least about 40%, and particularly preferably at least about 60% and desirably above 80% of the binding component of the composition.
  • the pharmaceutical composition is typically formed into a dosage form such as a tablet or a capsule.
  • the formed pharmaceutical composition e.g. in the form of small pellets, powder, and the like, may be incorporated into a capsule or a sachet.
  • the active ingredient may be an analgesic, an antipyretic agent, an anti-inflarnmatory agent, a vitamin, an expectorant, an antibiotic, etc.
  • analgesic an antipyretic agent
  • an anti-inflarnmatory agent a vitamin, an expectorant, an antibiotic, etc.
  • the pharmaceutical compositions of the invention may be used for essentially all types of different active ingredients, which are compatible with the
  • Echinacea preparation Furthermore, the pharmaceutical composition of the invention is intended for oral administration and thus the active ingredient should be adapted for such form of administration, namely, should be orally bioavailable.
  • active ingredients are paracetamol, carbocysteine, dextrometho han, loratadine and vitamin C.
  • the invention also provides, by another of its aspects, a process for forming a pharmaceutical composition, comprising: (a) preparing a mixture comprising at least one active ingredient and an excipient;
  • the present invention provides a method of administering Echinacea preparation and a pharmaceutically active ingredient to an individual, comprising: (a) preparing a mixture comprising said active ingredient, an excipient and the Echinacea preparation;
  • the invention even further provides use of an excipient of Echinacea preparation and an active ingredient to yield a pharmaceutical composition wherein said preparation binds together components of the composition.
  • Fig. 1 shows the size distribution of the particles obtained in example 1.
  • Fig. 2 shows the size distribution of the particles obtained in example 2.
  • Echinacea preparation was Echinacea purpurea E, supplied by Pharmabeta AG, Switzerland and in examples 2, 3, and 4 the Echinacea preparption was Echinacea Plante Extrait Sec supplied by Martin Bower, France.
  • Example 1 Preparation of Paracetamol tablets with Echinacea as a single binder.
  • Example 2 Preparation of carbocystein capsules with Echinacea as a single binder.
  • the Echinacea solution was added to the mixture of the powders and manually stirred to granulation.
  • the dry granulate was ground on a 1 mm net and mixed with 7 g Avicel and 1 g magnesium stearate to give the final blend.
  • the final blend was filled inside hard gelatin capsules of capsule size no. 0, 375 mg active ingredient per capsule.
  • the particle size distribution of the final blend is shown in Figure 2.
  • Example 3 Application of dextromethorphan on pellets, using Echinacea as a binder.
  • Echinacea 8 g of Echinacea were dissolved in 300 ml of purified water, and 4 g of PEG 4000 were added to the solution.
  • 40 g of dextromethorphan HBr were added to the solution to give a dispersion. The dispersion was applied to Neutral pellets No. 20 during heating. 40 g of dextromethyorphan HBr were suspended in tge a/m solution and sprayed on neutral sugar sphere (pellets size 20) using Glatt-Wurster equipment. Coated pelletswere filled inside hard gelatin capsules.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Botany (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Pharmaceutical compositions, which contain a binder that comprises a binding-effective amount of Echinacea preparation are described.

Description

A BINDER FOR PHARMACEUTICAL COMPOSITIONS
FIELD OF THE INVENTION
The present invention is generally in the field of pharmaceutics and concerns a pharmaceutical composition comprising an active ingredient and a binder holding together the constituents of the composition.
BACKGROUND OF THE INVENTION AND PRIOR ART
Pharmaceutical compositions typically consist of at least one active ingredient and several excipients. The excipients may be disintegrants, which assist in releasing the active ingredient under the desired conditions, lubricants, which improve ejection from machine tooling, glidents, which improve flow, binders, which bind together different ingredients of the composition, etc.
Binders are of special importance in solid dosage forms, like tablets, pellets, microgranules, and sachets, where they are essential for holding together several different solid ingredients.
Pharmaceutically acceptable binders that are in wide use include, for example: starch, starch derivatives, polyvimlpyrolidone (PVP), alginate derivatives, and glucose.
Echinacea is well known as a food additive, and as such is known to be safe for consumption. It was also proposed as a pharmaceutically active ingredient, and the British Herbal Pharmacopeia (1996) defines it as an immunostimulant. Derwent Abstract No. 012237708 describes a drug that comprises paracetamol, caffeine, Echinacea and several other ingredients for use as an analgesic. Derwent Abstract No. 012234518 describes a cold treatment agent that comprises Echinacea and antipyretic and anti-inflammatory agent. GENERAL DESCRIPTION OF THE INVENTION
In accordance with the invention powder or extract of Echinacea is used as a binder in solid pharmaceutiacal compositions, e.g. compositions in the form of tablets, pellets, capsules, microgranules, powders, etc. Echinacea powder or extract (hereiafter Echinacea preparation) may be obtained from Echinacea leafes, roots, or whole plants. Examples of Echinacea species that preparations thereof are suitable to serve as binders according to the present invention are those known as Echinacea purpurea, Echinacea angustifolia, Echinacea pallida, Echinacea paradoxa, Echinacea tennesseensis, Echinacea sanguinea, Echinacea simulata and Echinacea atrotubens.
Examples of Echinacea preparations are Echinacea angustifoliae herba et radix, Echinacea pallidae herba, Echinacea pallidae radix, Echinacea purpureae herba, and Echinacea purpureae redix.
Thus, the present invention provides, by a first of its aspects, a pharmaceutical composition comprising particulate matter containing at least one pharmaceutically active ingredient and a binder, characterized in that said binder comprises a binding-effective amount oϊEchinacea preparation.
The term "binding-effective amount" should be understood to denote an amount of Echinacea preparation effective in binding or assisting in binding together components of the composition. The binder may consist of Echinacea preparation or may be a mixture of Echinacea preparation and other ingredients, with the Echinacea preparation having a role in binding the compositions' component together. The property of being included in a binding-effective amount is manifested in that when the Echinacea preparation is removed, the composition's other components will not bind to one another at sufficient strength to hold the composition's components together. In the presence of a binding-effective amount oϊEchinacea preparation, there is a measurable improvement of physical properties such as hardness (in tablets) and of flowability (in powders) in comparison to the same tablets or powders in the absence of binding-effective amount of Echinacea preparation. Typically, the Echinacea preparation will constitute at least about 20% of the binding component of the composition, preferably at least about 40%, and particularly preferably at least about 60% and desirably above 80% of the binding component of the composition.
The pharmaceutical composition is typically formed into a dosage form such as a tablet or a capsule. At times, the formed pharmaceutical composition, e.g. in the form of small pellets, powder, and the like, may be incorporated into a capsule or a sachet.
The active ingredient may be an analgesic, an antipyretic agent, an anti-inflarnmatory agent, a vitamin, an expectorant, an antibiotic, etc. These types of active ingredients are but an example and the invention is not limited thereto. On the contrary, the pharmaceutical compositions of the invention may be used for essentially all types of different active ingredients, which are compatible with the
Echinacea preparation. Furthermore, the pharmaceutical composition of the invention is intended for oral administration and thus the active ingredient should be adapted for such form of administration, namely, should be orally bioavailable.
Specific examples of active ingredients are paracetamol, carbocysteine, dextrometho han, loratadine and vitamin C.
The invention also provides, by another of its aspects, a process for forming a pharmaceutical composition, comprising: (a) preparing a mixture comprising at least one active ingredient and an excipient;
(b) adding a binder to said mixture; and
(c) processing said mixture to yield an administration form, in which form said binder binds together ingredients of the composition; said process being characterized in that said binder comprises a binding- effective amount oϊEchinacea preparation and said processing comprises applying conditions in which said preparation binds together ingredients of the composition. By a still further aspect, the present invention provides a method of administering Echinacea preparation and a pharmaceutically active ingredient to an individual, comprising: (a) preparing a mixture comprising said active ingredient, an excipient and the Echinacea preparation;
(b) processing the mixture to obtain an administration form, said processing being under conditions such that said preparation bind together all the ingredients in the administration form;
(c) administering said administration form to the individual.
The invention even further provides use of an excipient of Echinacea preparation and an active ingredient to yield a pharmaceutical composition wherein said preparation binds together components of the composition. The invention will now be illustrated in the following non-limiting examples.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 shows the size distribution of the particles obtained in example 1. Fig. 2 shows the size distribution of the particles obtained in example 2.
EXAMPLES
In the following example 1 the Echinacea preparation was Echinacea purpurea E, supplied by Pharmabeta AG, Switzerland and in examples 2, 3, and 4 the Echinacea preparption was Echinacea Plante Extrait Sec supplied by Martin Bower, France.
Example 1: Preparation of Paracetamol tablets with Echinacea as a single binder.
11.6 g of Echinacea were dissolved in 60 ml of purified water and the solution was poured drop-wise on 215 g of paracetamol and mixed with it manually. The mixture was dried in 45°C (LOD=1.0%). The resulting dry granulate was ground in a 1 mm net. 1 g magnesium stearate and 9.0 g of Primojel were added. The mixture was moistured with a little water and dried (LOD=2.8%). The dried mixture was then pressed to give round tablets of 13 mm diameter, each containing 500 mg of paracetamol. The hardness of the tablets was 44±5 N. The size distribution of the resulting particles is shown in Figure 1.
Example 2: Preparation of carbocystein capsules with Echinacea as a single binder.
5 g oϊEchinacea preparation were dissolved in 30 ml water.
187.5 g of carbocystein were mixed with 4 g of Avicel.
The Echinacea solution was added to the mixture of the powders and manually stirred to granulation. The granulate was dried at 40°C (LOD=0.7%). The dry granulate was ground on a 1 mm net and mixed with 7 g Avicel and 1 g magnesium stearate to give the final blend. The final blend was filled inside hard gelatin capsules of capsule size no. 0, 375 mg active ingredient per capsule. The particle size distribution of the final blend is shown in Figure 2.
Example 3: Application of dextromethorphan on pellets, using Echinacea as a binder.
8 g of Echinacea were dissolved in 300 ml of purified water, and 4 g of PEG 4000 were added to the solution. 40 g of dextromethorphan HBr were added to the solution to give a dispersion. The dispersion was applied to Neutral pellets No. 20 during heating. 40 g of dextromethyorphan HBr were suspended in tge a/m solution and sprayed on neutral sugar sphere (pellets size 20) using Glatt-Wurster equipment. Coated pelletswere filled inside hard gelatin capsules.
Example 4: Preparation of Loratadine tablets by direct compression with
E Wrchhiinn narcøean
10 g of Loratadine were mixed with 25 g of Echinacea. The mixture was sieved on a 50 mesh sieve. 163 g of Lactose DC were added and mixed. 2 g of magnesium stearate were added and mixed to give the final mixture. The final mixture was pressed in a die to give tablets that contained 100 mg and 200 mg active ingredient. The 100 mg tablets had hardness of 99±1 N and the 200 mg tablets had hardness of 85±1 N.

Claims

CLAIMS:
1. A pharmaceutical composition comprising particulate matter containing a pharmaceutically active ingredient and a binder, characterized in that said binder comprises a binding-effective amount oϊEchinacea preparation.
2. A pharmaceutical composition according to Claim 1, wherein said binder holds said particulate matter to yield a dosage form of the active ingredient.
3. A pharmaceutical composition according to Claim 2, wherein said dosage form is in the form of a tablet.
4. A pharmaceutical composition according to Claim 2, comprising pellets; each of which comprising said active ingredient and said binder.
5. A capsule containing a pharmaceutical composition according to any of Claims 1, 2 or 4.
6. A pharmaceutical composition according to any one of Claims 1-5, wherein the active ingredient is an analgesic, an antipyretic agent, an anti- inflammatory agent, an anti histamine agent, an expectorant, an antibiotic agent, or a vitamin.
7. A pharmaceutical composition of Claim 6, wherein the active ingredient is paracetamol, carbocysteine, dextromethorphan or loratadine.
8. A process of forming a pharmaceutical composition, comprising;
(a) preparing a mixture comprising an active ingredient and an excipient; (b) adding a binder to said mixture; and
(c) processing said mixture to yield an administration form, in which form said binder binds together ingredients of the composition; said process being characterized in that said binder comprises a binding- effective amount of Echinacea preparation and said processing comprises applying conditions in which said preparation binds together ingredients of the composition.
9. A method of administering Echinacea preparation and a pharmaceutically active ingredient to an individual, comprising:
(a) preparing a mixture comprising said active ingredient, an excipient and the Echinacea preparation; (b) processing the mixture to obtain an administration form, said processing being under conditions such that said preparation binds together ingredients in the administration form;
(c) administering said administration form to the individual.
10. A method of administering Echinacea preparation and a pharmaceutically active ingredient to an individual, comprising:
(a) providing an administration form comprising the active ingredient, an excipient and the Echinacea preparation, and wherein said preparation binds together ingredients in said administration form; (b) administering said administration form to the individual.
11. Use of an excipient oϊ Echinacea preparation and an active ingredient to yield a pharmaceutical composition wherein said preparation binds together components of the composition.
PCT/IL2000/000412 1999-08-09 2000-07-13 A binder for pharmaceutical compositions WO2001010415A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA002378987A CA2378987C (en) 1999-08-09 2000-07-13 A binder for pharmaceutical compositions
EP00944197A EP1200069A1 (en) 1999-08-09 2000-07-13 A binder for pharmaceutical compositions
AU58428/00A AU5842800A (en) 1999-08-09 2000-07-13 A binder for pharmaceutical compositions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL131317A IL131317A (en) 1999-08-09 1999-08-09 Binder for pharmaceutical compositions
IL131317 1999-08-09

Publications (2)

Publication Number Publication Date
WO2001010415A1 true WO2001010415A1 (en) 2001-02-15
WO2001010415B1 WO2001010415B1 (en) 2001-08-16

Family

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Application Number Title Priority Date Filing Date
PCT/IL2000/000412 WO2001010415A1 (en) 1999-08-09 2000-07-13 A binder for pharmaceutical compositions

Country Status (5)

Country Link
EP (1) EP1200069A1 (en)
AU (1) AU5842800A (en)
CA (1) CA2378987C (en)
IL (1) IL131317A (en)
WO (1) WO2001010415A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005816A1 (en) * 2000-07-17 2002-01-24 Ranbaxy Laboratories Limited A bioavailable dosage form of loratadine

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT385654B (en) * 1984-09-04 1988-05-10 Arcana Chem Pharm Process for the production of oil-containing preparations in granule form for oral administration
WO1993013754A1 (en) * 1992-01-17 1993-07-22 Alfatec-Pharma Gmbh Moulded bodies, in particular pellets, containing one or more plant extracts, and the pharmaceutical or cosmetic use of such pellets
EP0743062A1 (en) * 1995-05-17 1996-11-20 Peter Greither Effervescent preparation and production method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT385654B (en) * 1984-09-04 1988-05-10 Arcana Chem Pharm Process for the production of oil-containing preparations in granule form for oral administration
WO1993013754A1 (en) * 1992-01-17 1993-07-22 Alfatec-Pharma Gmbh Moulded bodies, in particular pellets, containing one or more plant extracts, and the pharmaceutical or cosmetic use of such pellets
EP0743062A1 (en) * 1995-05-17 1996-11-20 Peter Greither Effervescent preparation and production method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
R. YAMIN: "Citizen petition to establish safety of Echinacea extract as a GRAS pharmaceutical formulation aid - CMC section", FDA DOCKETS, 15 September 2000 (2000-09-15), XP002153814, Retrieved from the Internet <URL:http://www.fda.gov/ohrms/dockets/dailys/00/Sep00/091100/cp00001%20attachment_1.pdf> [retrieved on 20001124] *
See also references of EP1200069A1 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005816A1 (en) * 2000-07-17 2002-01-24 Ranbaxy Laboratories Limited A bioavailable dosage form of loratadine

Also Published As

Publication number Publication date
AU5842800A (en) 2001-03-05
WO2001010415B1 (en) 2001-08-16
IL131317A0 (en) 2001-01-28
EP1200069A1 (en) 2002-05-02
CA2378987A1 (en) 2001-02-15
CA2378987C (en) 2008-05-06
IL131317A (en) 2006-08-01

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