WO2002000197 METHOD OF MAKING PARTICLES FOR USE IN A PHARMACEUTICAL COMPOSITION

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Publication Number WO/2002/000197

Publication Date 03.01.2002

International Application No. PCT/GB2001/002860

International Filing Date 27.06.2001

Chapter 2 Demand Filed 12.01.2002

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Applicants

VECTURA LIMITED [GB]/[GB] (AllExceptUS)
STANIFORTH, John, Nicholas [GB]/[GB] (UsOnly)
MORTON, David, Alexander, Vodden [GB]/[GB] (UsOnly)
MUSA, Rosella [IT]/[IT] (UsOnly)

Inventors

STANIFORTH, John, Nicholas
MORTON, David, Alexander, Vodden
MUSA, Rosella

Agents

JUMP, Timothy

Priority Data

00113608.4	27.06.2000	EP
0029263.1	30.11.2000	GB
PCT/GB01/01732	17.04.2001	GB

Publication Language English (en)

Filing Language English (EN)

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Title

(EN) METHOD OF MAKING PARTICLES FOR USE IN A PHARMACEUTICAL COMPOSITION

(FR) PROCEDE PERMETTANT DE PRODUIRE DES PARTICULES DESTINEES A ETRE UTILISEES DANS UNE COMPOSITION PHARMACEUTIQUE

Abstract

(EN) A method for making composite excipient particles for use in a pharmaceutical composition comprises a milling step in which particles of an excipient material are milled in the presence of an additive material. The product particles are of small size and the milling requires relatively low input of time and energy. The composite particles are suitable for use in inhalable pharmaceutical compositions.

(FR) La présente invention concerne un procédé permettant de produire des particules composites servant d'excipients destinées à être utilisées dans une composition pharmaceutique, comprenant une étape de broyage durant laquelle des particules d'une substance servant d'excipient sont broyées en la présence d'une substance d'addition. Les particules obtenues sont de petite taille, et le broyage requière relativement peu de temps et d'énergie. Les particules composites peuvent être utilisées dans des compositions pharmaceutiques à inhaler.

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
14	Particulate form, e.g. powders

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
16	Amides, e.g. hydroxamic acids
165	having aromatic rings, e.g. colchicine, atenolol, progabide
167	having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
56	Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
57	substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane, progesterone
573	substituted in position 21, e.g. cortisone, dexamethasone, prednisone

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
56	Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
58	containing heterocyclic rings, e.g. aldosterone, danazol, stanozolol, pancuronium, digitogenin

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
14	Particulate form, e.g. powders

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1. WO2002000197 - METHOD OF MAKING PARTICLES FOR USE IN A PHARMACEUTICAL COMPOSITION

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
P	SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
11	Drugs for disorders of the respiratory system
06	Antiasthmatics

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
0012	Galenical forms characterised by the site of application
007	Pulmonary tract; Aromatherapy
0073	Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy;
0075	for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
14	Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
141	Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
145	with organic compounds

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
14	Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16	Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605	Excipients; Inactive ingredients
1617	Organic compounds, e.g. phospholipids, fats

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
14	Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16	Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605	Excipients; Inactive ingredients
1617	Organic compounds, e.g. phospholipids, fats
1623	Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules