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Particulate composition

a technology of composition and particles, applied in the field of particles composition, can solve problems such as adversely affecting the stability of medicaments

Inactive Publication Date: 2006-05-04
UNIV COLLEGE CARDIFF CONSULTANTS LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0020] The surfactant material contained in the present particulate composition can determine the surface properties of the particles. In particular, the choice of surfactant material can permit the exterior surface of the particles to be tailored to a specific application.
[0021] For example, when contained in an aerosol composition the surfactant material contained in the present particulate composition can aid dispersion of the particles throughout the liquid propellant.
[0023] The presence of the surfactant in the present particulate composition can ensure a smooth exterior surface to the particles.

Problems solved by technology

Any such residues are inevitably present in a cross-linked polymer product formed using cross-linking agent and initiator, albeit, in small amounts, and are potentially toxic in in vivo applications and capable of adversely affecting the stability of the medicament.

Method used

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  • Particulate composition
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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0109] A microemulsion composition was prepared following the above procedure from 78% w / w iso-octane, 6% w / w sodium bis (2-ethylhexyl) sulphosuccinate, and 16% w / w of an aqueous phase. The aqueous phase comprised, with respect to the aqueous phase, 0.06% w / w bromothymol blue and 17.17% w / w polyacrylic acid (molecular weight 2000), with the balance being water.

[0110] The size of the resulting particles was measured using the photon correlation spectroscopy technique described above employing the Coulter N4. The particles were found to be 232±58 nm, n=7 mean±sd.

[0111] The particles were also subjected to scanning electron microscopy employing the procedure described above. FIG. 2 is the scanning electron micrograph of the present particles. The particles appear spherical and to have a diameter of approximately 250 nm, which is in line with the data from the photon correlation spectroscopy sizing data.

example 2

[0112] Microemulsion compositions were prepared following the above procedure for three compositions comprising iso-octane, lecithin:propan-2-ol(1:3 w / w) and an aqueous phase. The relative proportions of each phase and the content of the aqueous phase are given in Table I below.

TABLE ISurfactant (% w / w)Iso-octaneLecithin:Aqueous PhaseFormulation(% w / w)Propan-2-ol (1:3)(% w / w) / compositionB254530 / salbutamol sulphate(17% w / v)C354520 / salbutamol sulphate(17% w / v)D404020 / salbutamolsulphate:lactose(70:30)(17% w / v)

[0113] The size of the resulting particles formed from each formulation was measured by photon correlation spectroscopy employing the Coulter N4 machine in the above described procedure. The results are given in Table II below.

TABLE IINanoparticle size by PCS (scattering intensity)Formulation(mean ± sd, n = 7)BPopulation 1 (50.4%): 216 ± 43 nmPopulation 2 (49.6%): 40 ± 15 nmC34 ± 17 nmD69 ± 39 nm

[0114] A scanning electron micrograph of the salbutamol sulphate nanoparticles res...

example 3

[0115] Each of the nanoparticles resulting from the ternary formulations of Example 2 was employed to produce an aerosol composition.

[0116] In each case ˜30 mg of nanoparticles were dispersed in 0.5 g n-hexane with 3 minutes sonication in a plastic vial for use in a pressurised metered dose inhaler. A Bespak BK 357 100 μl metering valve was crimped in place and hydrofluoroalkane propellant (14 g HFA-227) was added using a pressure burette. The valve was actuated through a mouthpiece with a 0.25 mm orifice.

[0117] Visual evaluation of the compositions was performed prior and subsequent to sonication and at later time points to assess formulation stability and homogeneity.

[0118] The aerosol performance of each resulting nanoparticle HEFA formulations was assessed by cascade impaction. The plates of an Andersen cascade impactor were coated with polyethylene glycol (molecular weight 300) to reduce particle bounce and re-entrainment.

[0119] In each case the pressurised metered dose inh...

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Abstract

Nanoparticles are prepared from a colloidal system comprising a continuous phase and micelles, the micelles comprising surfactant material. A microemulsion is formed by admixing the colloidal system with a solution of an active material, such as a medicament, dissolved in a solvent wherein the solution forms a disperse phase with the micelles of surfactant material. At least the dispersed phase is quenched to a solid state and the continuous phase and solvent are removed to produce the nanoparticles. The nanoparticles can be incorporated in an aerosol composition suitable for deep lung delivery by means of a metered dose inhaler.

Description

CROSS REFERENCE TO PRIOR APPLICATION [0001] This application is continuation of U.S. application Ser. No. 10 / 258,190, filed Jan. 17, 2003 which is a National Stage under 35 U.S.C. §371 of PCT International Application No. PCT / GB01 / 01752, filed Apr. 18, 2001, which claims the benefit under 35 U.S.C. § 19(e) of prior British Application No. 0009773.3, filed Apr. 19, 2000, the entire contents of which are incorporated herein by reference. The International Application was published in English on Oct. 25, 2001 as WO 01 / 78689 under PCT Article 21(2).BACKGROUND OF THE INVENTION [0002] The present invention relates to a particulate composition and to a method for preparing a particulate composition. Particularly, but not exclusively, the present invention also relates to an aerosol composition including the present particulate composition and to the use of such an aerosol composition in administering a medicament, for example, for treating a respiratory disease. [0003] There have been a nu...

Claims

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Application Information

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IPC IPC(8): A61K48/00A61K38/22A61K31/573A61K31/4745A61K9/14A61L9/04A61K9/00A61K9/107A61K9/12A61K9/51
CPCA61K9/008A61K9/1075A61K9/5123A61K9/5138A61K9/5169
Inventor DICKINSON, PAUL ALFREDKELLAWAY, IAN WALTERHOWELLS, STEPHEN WYN
Owner UNIV COLLEGE CARDIFF CONSULTANTS LTD
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