US3634582A - Pharmaceutical compositions - Google Patents

Pharmaceutical compositions Download PDF

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Publication number
US3634582A
US3634582A US748937A US3634582DA US3634582A US 3634582 A US3634582 A US 3634582A US 748937 A US748937 A US 748937A US 3634582D A US3634582D A US 3634582DA US 3634582 A US3634582 A US 3634582A
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United States
Prior art keywords
microns
particle size
range
medicament
composition
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US748937A
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English (en)
Inventor
Philip Saxton Hartley
Stephen Raymond Gunning
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Fisons Pharmaceuticals Ltd
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Fisons Pharmaceuticals Ltd
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US case filed in New Jersey District Court litigation Critical https://portal.unifiedpatents.com/litigation/New%20Jersey%20District%20Court/case/2%3A18-cv-12663 Source: District Court Jurisdiction: New Jersey District Court "Unified Patents Litigation Data" by Unified Patents is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fisons Pharmaceuticals Ltd filed Critical Fisons Pharmaceuticals Ltd
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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents

Definitions

  • the new compositions comprise a powdered medicament of a particle size inthe range of 0.01 to microns and a solid pharmaceutically acceptable water soluble carrier of a particle size of 30 to 80 microns.
  • the present invention relates to improved pharmaceutical compositions for oral inhalation.
  • the invention is concerned with pharmaceutical compositions which are to be dispersed into an air stream by a fluidisation technique which uses the inspiratory action of the inhaler as the principal source of energy.
  • the fiuidisation technique is that achieved when powder within a container is subjected to simultaneous rotation and vibration.
  • Such fluidisation is achieved in the dispenser described in French Pat. No. 1,471,722.
  • An example of such a form of device is one which comprises a hollow elongate housing having at both ends thereof one or more passageways adapted to permit the passage of air and having one end thereof adapted for insertion into the mouth and a propeller-like device rotatably mounted in the said housing on a rigid shaft mounted in said housing and co-axial with the longitudinal axis of the housing; said propeller-like device having, on the part thereof furthest from the end of the housing adapted for insertion into the mouth, mounting means adapted to receive a container, such as a gelatine or like capsule for the medicament to be inhaled.
  • a container such as a gelatine or like capsule for the medicament to be inhaled.
  • Medicaments for administration by inhalation should be of a controlled particle size in order to achieve maximum penetration into the lungs; a suitable particle size range being 0.01 to 10, usually 1-10 microns.
  • powders in this particle size range are not readily fluidised by the above technique because of cohesive forces between the individual particles.
  • such particles may be rendered readily fluidisable and thus suitable for inhalation using such fiuidising techniques by mixing the finely divided medicament or pharmaceutically active material with a coarser carrier medium whose particles have sizes falling within a given range.
  • a pharmaceutical powder composition for inhalation which comprises a mixture of a solid finely divided medicament having an effective particle size in the rage of 0.01 to 10 microns and a solid pharmaceutically acceptable Water soluble carrier having an effective particle size in the range of from 30 to microns.
  • the composition is substantially free of particles in the effective size range 11 to 29 mircrons.
  • the sample to be analysed is dispersed in an electrolyte into which dips a glass tube.
  • the glass tube has a hole through the wall thereof with electrodes mounted on either side of the hole in the tube wall.
  • the tube is immersed sufficiently for the hole and electrodes to be submerged in the liquid.
  • the suspension is made to flow through the hole in the glass tube and as each particle passes through the orifice it displaces its own volume of electrolyte, thus changing the resistance across the hole.
  • This change in resistance is converted into a voltage pulse with an amplitude proportional to the particle volume.
  • the pulses are fed to an electronic counter with an adjustable threshold level such that all pulses above the threshold are counted.
  • the composition may contain any of a Wide variety of medicaments suitable for administration by inhalation, e.g. medicaments intended for allevation of disorders of the bronchial tract of medicaments administered for systemic action.
  • medicaments which may be employed in the composition of the invention are antianaphylactic agents such as sodium chromoglycate, sympathomimetic amines such as isoprenaline or ephedrine, antibiotics such as tetracycline, steroids, enzymes, vitamins, antihistamines and mucolytics such as N-acetyl cysteine.
  • the composition may contain more than one medicament in finely divided form.
  • a composition may contain, for example, a mixture of sodium chromoglycate and isoprenaline sulphate.
  • the medicament should be in finely divided form having an effective particle size in the range 0.01-l0, preferably 1-10 microns, and suitably at least 50% by weight of the finely divided medicament is in the effective particle size range 26 microns.
  • the medicament is one of high specific activity, it may be desirable to dilute the medicament with an inert diluent of similar particle size.
  • Such a composition should, of course, also contain a coarser carrier having an effective particle size in the range 30-80 microns.
  • the solid diluent or carrier in the composition will generally be a non-toxic material chemically inert to the medicament but may, if so desired, comprise larger sized particles of the medicament.
  • the carrier has an effective particle size in the range 30-80 microns preferably 30-70, especially 30-60 microns.
  • water-soluble solid diluents or carriers which may be used in the composition of the invention include dextran, mannitol and, preferably, lactose.
  • a particularly preferred diluent or carrier is crystalline lactose.
  • the composition be substantially free from particles having an effective size in the range 11 to 29 microns.
  • substantially free is used herein and in the claims to denote that the composition contains less than 10%, preferably less than by weight thereof of particles having effective sizes in the range 11 to 29 microns.
  • the ratio of medicament or other finely divided material to carrier may vary depending upon the materials used. The optimum ratio will depend upon the nature of the medicament and carrier and the method by which the composition is to be applied. We have found that the use of from -75% by weight of finely divided material to 90-25% by weight of carrier, preferably from 20 to 60% by weight of finely divided materials, e.g. about 35 to 50% by weight of medicament to 65 to 50% by weight of carrier, provides satisfactory results.
  • the finely divided medicament or other material may be prepared by direct milling down to the desired particle size range.
  • the particulate carrier may be prepared by grinding the carrier and subsequently separating out the desired fraction by conventional methods, e.g. by air classification and sieving.
  • the surface characteristics of individual particles of both the medicament and carrier may be modified by such conventional techniques as crystallisation, spray drying and precipitation.
  • compositions may be prepared from the fine and coarse ingredients by mixing the ingredients together in a mixer, such as a planetary or other stirred mixer.
  • the invention thus also provides a method for preparing a composition of the invention which comprises mixing together the finely divided material and the coarse carrier, after comminution and classification of the ingredients if this is necessary.
  • the surfaces of the particles of medicament and/or diluent and/or carrier may be coated with a pharmaceutically acceptable material, such as stearic acid, or polymers such as polyvinyl pyrrolidone. This coating procedure may serve incidentally to give a sustained release action to the medicament.
  • the composition may contain other ingredients, such as colouring matter or' flavouring agents such as saccharin, which are normally present in inhalant compositions. It is, however, preferred to use the minimum of such other ingredients and that, when present, they should have effective particle sizes in the range 3080 microns.
  • compositions according to the invention will generally be put up in gelatine, plastic or other capsules.
  • a dosage unit comprising a gelatine or like capsule containing a pharmaceutical composition comprising a mixture of a solid finely divided medicament having an effective particle size in the range of from 0.01 to 10 microns and a solid pharmaceutically acceptable water soluble carrier having an affective particle size in the range of from 30 to 80 microns.
  • composition contained in the capsule will, of course, to some extent depend on the specific activity of the medicament and the desired dosage. However, where possible the capsule suitably contains from 10 to 100 mg. of the composition and for medicaments of high specific activity it may be desirabie to dilute the medicament with an inert diluent of similar particle size as described above.
  • EXAMPLE 1 Commercially available ground crystalline lactose having an effective particle size of from 1 to 100 microns (less than 30% by weight greater than 60 microns, not more than 30% by weight less than 30 microns) was passed through an air classifier, set to remove material having an effective particle size of less than 30 microns. T he product from the air classifier contained less than 4% by weight of material of less than 32 microns effective size. This product was then sieved through a sieve having a mesh aperture of 63 microns to produce a lactose product which contained less than 10% by weight of particles with an effective size less than 32 microns and less than 20% by weight with an efiective particle size in excess of 62 microns as determined on an Alpine air jet sieve.
  • the medicament or other material such as lactose which was intended to form the finely divided material was passed through a fluid energy mill in an air stream until the product contained at least 50% by weight of particles in the effective size range 2-6 microns as determined on a Coulter counter.
  • compositions containing the desired proportions of the coarse and fine materials were mixed together in a planetary mixer and the mixture then passed through a 30 mesh sieve to remove or break up agglomerated particles.
  • compositions were then put up in gelatine capsules containing about 40 mg. of the composition (capsule approximately /3 full) and the ease of emptying of the composition from the capsule determined.
  • the ease of emptying was assessed by mounting a pierced capsule in the capsule holder of the powder insufflator of French patent specification No. 1,471,722.
  • the insutflator was then mounted in a hole in the side wall of a chamber connected to a bellows.
  • the bellows were designed to suck air through the chamber, and hence the insufflator acting as the air inlet. thereinto, at a rate of 1 litre per second. Each suck of the bellows lasted one second.
  • the capsule was weighed prior to mounting in the insufl'lator. The bellows were then operated to give seven one second sucks and the capsule reweighed to determine the amountof powder removed from the capsule. The amount of powder removed is related to the ease of fluidisation of the powder.
  • compositions prepared and tested are set out in Table I.
  • a composition containing no coarse diluent was prepared and tested in each case.
  • Those compositions containing the coarse carrier were all found to empty from the capsulese at a satisfactory rate, in general from to of the composition, whereas in the absence of the coarse diluent the emptying rates were much lower, about 15% or less, and were unpredictable.
  • compositions of the present invention are useful inter alia as anaphylactic compositions for the treatment of disorders of the bronchial tract, e.g. asthma, specific allergic asthma, etc., as mucolytica in the treatment of colds and the like which cause the accumulation of mucus in the respiratory tract, etc., of warm-blooded animals (mammals).
  • the medicaments proper are per se known and the compositions are administered in such dosages as to afford the known eifective amounts of the medicaments for their respective purposes.
  • Coarse carrier nature of weight
  • Fine material nature of material and efiective particle size used material and efiective particle size used
  • Sodium chromoglycate (1-10 1, at least 507 w/w in the range 2-6 20 lsoprenaline sulphate 8-10 [.L, at least 50%, iv/lw in giro range 216 1)) 0.
  • icrystanme lactose 32-63 9 soprena ine su p a e On, a. eas 50 w w in e range 2- M. 0.
  • Crystalline lactose (1-10 ii, at least 50% ⁇ v /w in the range 2-6 11).
  • 10 Crystaliine lactose (32-63 It) 30 TABLE 2 Effective Percent w/w Parts by particle Parts by of material Effective particle size in weight Nature of coarse size in weight removed Nature of fine material microns used material microns used from capsule Sodium chromoglycateun 1-10, at least 50% w/w 2-6.
  • a powder composition for inhalation which consists essentially of a heterogeneous particle size readily fluidizable mixture of a solid finely divided medicament having an eifective particle size in the range 0.01 to 10 microns and a solid pharmaceutically acceptable water soluble inhalation powder carrier having an effective coarser particle size in the range -80 microns.
  • composition as claimed in claim 1 which is substantially free of particles having eifective particle sizes in the range 11-29 microns.
  • composition according to claim 1 wherein the medicament has an effective particle size in the range 1-10 microns.
  • a composition according to claim 3 wherein at least 50% by weight of the finely divided medicament has an effective particle size in the range 2-6 microns.
  • composition according to claim 1 wherein the carrier has an eiiective particle size in the range 30-70 microns.
  • composition according to claim 1 wherein the medicament is diluted with a solid pharmaceutically acceptable water soluble diluent of the same effective particle size.
  • composition according to claim 1 wherein the carrier comprises particles of medicament with an effective particle size in the range 30-80 microns.
  • composition according to claim 1 wherein the carrier material is selected from the group consisting of dextran, mannitol and lactose.
  • composition according to claim 8 wherein the lactose is a crystalline lactose.
  • composition according to claim 1 wherein the medicament is selected from the group consisting of sodium chromoglycate, isoprenaline, ephedrine, tetracycline, penicillin, salts thereof and mixtures thereof.
  • a powder composition for inhalation which consists essentially of from 10 to by Weight of a finely divided solid medicament for inhalation having an eifective particle size in the range 1 to 10 microns with at least 50% by weight of the particles in the effective size range 2 to 6 microns and from 90 to 25% by weight of a solid pharmaceutically acceptable water-soluble inhalation powder carrier having an effective coarser particle size in the range 30 to microns; said composition being substantially free from medicament and carrier particles having eifective particle sizes in the range 11 to 29 microns.
  • a composition according to claim 13 which comprises a mixture of sodium ohromoglycate having an eifective particle size in the range 0.01 to 10 microns and crystalline lactose having an effective particle size in the range 30 to 80 microns.
  • a composition according to claim 12 which cornprises from 10 to 75% by Weight of sodium chromoglycate having an effective particle size in the range 1 to 10 microns with at least 50% by weight of the particles in the effective size range 2 to 6 microns; and from to 25 by Weight of crystalline lactose having an effective particle size in the range 30 to 80 microns; said composition being substantially free from particles having efi'ective particle sizes in the range 11 to 29 microns.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Pulmonology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Otolaryngology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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US748937A 1967-08-08 1968-07-31 Pharmaceutical compositions Expired - Lifetime US3634582A (en)

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GB36270/67A GB1242211A (en) 1967-08-08 1967-08-08 Pharmaceutical composition

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US3634582A true US3634582A (en) 1972-01-11

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US (1) US3634582A (enrdf_load_stackoverflow)
JP (1) JPS5643448B1 (enrdf_load_stackoverflow)
BE (1) BE718846A (enrdf_load_stackoverflow)
CA (1) CA946280A (enrdf_load_stackoverflow)
DE (2) DE1792799A1 (enrdf_load_stackoverflow)
DK (1) DK123276B (enrdf_load_stackoverflow)
FI (1) FI48973C (enrdf_load_stackoverflow)
FR (2) FR8142M (enrdf_load_stackoverflow)
GB (1) GB1242211A (enrdf_load_stackoverflow)
IE (1) IE32343B1 (enrdf_load_stackoverflow)
MY (2) MY7400330A (enrdf_load_stackoverflow)
NL (1) NL161984C (enrdf_load_stackoverflow)
NO (1) NO128307B (enrdf_load_stackoverflow)
SE (1) SE372420B (enrdf_load_stackoverflow)

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SE372420B (enrdf_load_stackoverflow) 1974-12-23
FR8142M (enrdf_load_stackoverflow) 1970-08-17
IE32343B1 (en) 1973-06-27
MY7400330A (en) 1974-12-31
IE32343L (en) 1969-02-08
JPS5643448B1 (enrdf_load_stackoverflow) 1981-10-13
MY7400329A (en) 1974-12-31
FR1605538A (enrdf_load_stackoverflow) 1979-02-23
BE718846A (enrdf_load_stackoverflow) 1969-01-31
CA946280A (en) 1974-04-30
FI48973C (fi) 1975-03-10
FI48973B (enrdf_load_stackoverflow) 1974-12-02
DK123276B (da) 1972-06-05
DE1792207B2 (de) 1977-10-13
DE1792207C3 (de) 1978-06-29
DE1792799A1 (de) 1977-08-11
NL6811060A (enrdf_load_stackoverflow) 1969-02-11
GB1242211A (en) 1971-08-11
NO128307B (enrdf_load_stackoverflow) 1973-10-29
NL161984C (nl) 1980-04-15
NL161984B (nl) 1979-11-15
DE1792207A1 (de) 1971-11-04

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