GB821790A - Method of preparing sustained release particles and the product of the method - Google Patents

Method of preparing sustained release particles and the product of the method

Info

Publication number
GB821790A
GB821790A GB30707/57A GB3070757A GB821790A GB 821790 A GB821790 A GB 821790A GB 30707/57 A GB30707/57 A GB 30707/57A GB 3070757 A GB3070757 A GB 3070757A GB 821790 A GB821790 A GB 821790A
Authority
GB
United Kingdom
Prior art keywords
melting
point
lipid material
alcohol
powder
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.)
Expired
Application number
GB30707/57A
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.)
Smith Kline and French Laboratories Ltd
Original Assignee
Smith Kline and French Laboratories 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 Smith Kline and French Laboratories Ltd filed Critical Smith Kline and French Laboratories Ltd
Publication of GB821790A publication Critical patent/GB821790A/en
Expired 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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Abstract

A sustained release pharmaceutical powder is prepared by reducing a solid medicament to a particle size of a maximum of 10 microns, mixing the thus-formed particles in a liquefied lipid material which is substantially water-insoluble and has a melting-point of above 85 DEG C., solidifying the thus-formed mixture and then reducing the solidified mixture to form a primary powder having a maximum particle size in the range of from 5 to 25 microns, mixing the thus-formed powder with a melt of a lipid material which is substantially water-insoluble, emulsifiable with water, resistant to disintegration in the gastro-intestinal tract, and has a melting-point which is lower than the melting-point of the first-mentioned lipid material, mixing the powder-lipid mixture with water to form an emulsion while maintaining the mixture at a temperature of from above the melting-point of the second-mentioned lipid material and below the melting-point of the first-mentioned lipid material, cooling the emulsion to a temperature below the melting-point of the second-mentioned lipid material to precipitate the sustained release pharmaceutical powder. The first-mentioned lipid material may be in weight 5-35% of the total weight of medicament and lipid and may be resistant to disintegration in the gastro-intestinal tract. The second-mentioned lipid material may be in weight 25-85% of the total weight of primary powder and lipid and its melting-point should preferably be at least 5 DEG C. and advantageously 15 DEG C. below the melting-point of the primary lipid. The maximum size of the coated particles is 100 microns. Surface-active agents may be added to aqueous suspensions thereof. Specified primary coating materials are acrawax, carnauba wax, montan wax, chlorowax, stearamide, lauramide, myricyl alcohol, myristyl alcohol, hydrogenated castor oil, glyceryl tri-12-hydroxy stearate and the following mixtures: hydrogenated soy bean oil and ethyl cellulose, hydrogenated lard and ethyl cellulose, beeswax and ethyl cellulose, beeswax and methyl cellulose. The primary coating may be liquefied by heating and/or by the use of an organic solvent such as carbon tetrachloride, chloroform, trichloroethane, petroleum ether, benzene, toluene, ethyl acetate, xylene, nitrobenzene, acetone, ether, carbon disulphide, methyl ethyl ketone, methyl, ethyl and isopropyl alcohol. Specified secondary coating materials are beeswax, Japan wax, stearyl alcohol, cetyl alcohol, carnaubyl alcohol, cyryl alcohol, glyceryl distearate, glyceryl monostearate, glyceryl trimyristate, hydrogenated lard. To facilitate making an emulsion with water emulsifying agents, e.g. sodium lauryl sulphate may be added.
GB30707/57A 1956-11-20 1957-10-01 Method of preparing sustained release particles and the product of the method Expired GB821790A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US821790XA 1956-11-20 1956-11-20

Publications (1)

Publication Number Publication Date
GB821790A true GB821790A (en) 1959-10-14

Family

ID=22169543

Family Applications (1)

Application Number Title Priority Date Filing Date
GB30707/57A Expired GB821790A (en) 1956-11-20 1957-10-01 Method of preparing sustained release particles and the product of the method

Country Status (1)

Country Link
GB (1) GB821790A (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2064238A2 (en) * 1969-10-10 1971-07-16 Krupp Gmbh
US4834984A (en) * 1986-06-10 1989-05-30 Euroceltique S.A. Controlled release dihydrocodeine composition
US4935247A (en) * 1987-05-08 1990-06-19 Orion-Yhtyma Oy Composition for the oral administration of pharmaceuticals
US4935242A (en) * 1984-10-05 1990-06-19 Warner-Lambert Company Novel drug delivery system for expectorants
US5008118A (en) * 1987-06-23 1991-04-16 Nippon Oil And Fats Method for producing organic agent coated with powders of coating agent

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2064238A2 (en) * 1969-10-10 1971-07-16 Krupp Gmbh
US4935242A (en) * 1984-10-05 1990-06-19 Warner-Lambert Company Novel drug delivery system for expectorants
US4834984A (en) * 1986-06-10 1989-05-30 Euroceltique S.A. Controlled release dihydrocodeine composition
US4935247A (en) * 1987-05-08 1990-06-19 Orion-Yhtyma Oy Composition for the oral administration of pharmaceuticals
US5008118A (en) * 1987-06-23 1991-04-16 Nippon Oil And Fats Method for producing organic agent coated with powders of coating agent

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