Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof
AssigneeCyDex Pharmaceuticals, Inc.
InventorsJames D. Pipkin, Gerold L. Mosher, Douglas B. Hecker
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Abstract
A particulate SAE-CD composition is provided. The SAE-CD composition has an advantageous combination of physical properties not found in known solid forms of SAECD. In particular, the SAE-CD composition possesses an advantageous physicochemical and morphological property profile such that it can be tailored to particular uses. The SAE-CD composition of the invention has improved flow and dissolution performance as compared to known compositions of SAE-CD.
Claims20
A pharmaceutical composition comprising a sulfoalkyl ether cyclodextrin composition and an active agent, wherein the sulfoalkyl ether cyclodextrin composition comprises:
- (a) sulfoalkyl ether cyclodextrin;
- and
- (b) no more than about 20% by weight moisture;
- and wherein the sulfoalkyl ether cyclodextrin composition has a bulk density of about 0.38 g/cm3 to about 0.66 g/cm3 and
- a tapped density of about 0.49 g/cm3 to about 0.75 g/cm3, wherein the tapped density of the sulfoalkyl ether cyclodextrin composition is higher than the bulk density;
- and
- a gravitational-flow minimum orifice diameter of about 3 mm to about 12 mm;
- and wherein the sulfoalkyl ether cyclodextrin composition comprises agglomerated particles;
- and
- wherein the active agent is an antibiotic agent, an antihistamine agent, a decongestant, an anti-inflammatory agent, an antiparasitic agent, an antiviral agent, a local anesthetic, an antifungal agent, an antibacterial agent, an amoebicidal agent, a trichomonocidal agent, an analgesic agent, an anti-arthritic agent, an anti-asthmatic agent, an anticoagulant agent, an anticonvulsant agent, an antidepressant agent, an antidiabetic agent, an antineoplastic agent, an anti-psychotic agent, a neuroleptic agent, an antihypertensive agent, a hypnotic agent, a sedative agent, an anxiolytic energizer agent, an anti-Parkinson's disease agent, an anti-Alzheimer's disease agent, a muscle relaxant agent, an antimalarial agent, a hormonal agent, a contraceptive agent, a sympathomimetic agent, a hypoglycemic agent, an anti-hyperglyceridemia agent, an anti-dyslipidemia agent, a cholesterol reducing agent, a bile acid absorption inhibitor, an antilipemic agent, an ophthalmic agent, an electrolytic agent, a diagnostic agent, a prokinetic agent, a gastric acid secretion inhibitor agent, an anti-ulcerant agent, an anti-flatulent agent, an anti-incontinence agent, a cardiovascular agent, a corticosteroid, a B2 adrenoreceptor agonist, a dopamine D2 receptor agonist, an anticholinergic agent, an IL-5 inhibitor, an antisense modulators of IL-5, milrinone lactate, tryptase inhibitor, tachykinin receptor antagonist, leukotriene receptor antagonist, 5-lypoxygenase inhibitor, anti-IgE antibody, protease inhibitor or any combinations thereof.
A pharmaceutical composition comprising a sulfoalkyl ether cyclodextrin composition and an active agent, wherein the sulfoalkyl ether cyclodextrin composition comprises:
- (a) sulfoalkyl ether cyclodextrin;
- (b) no more than about 20% by weight moisture;
- and wherein the sulfoalkyl ether cyclodextrin composition has a bulk density of about 0.38 g/cm3 to about 0.66 g/cm3 and
- a tapped density of about 0.49 g/cm3 to about 0.75 g/cm3, wherein the tapped density of the sulfoalkyl ether cyclodextrin composition is higher than the bulk density;
- and
- a gravitational-flow minimum orifice diameter of about 3 mm to about 12 mm;
- and wherein the sulfoalkyl ether cyclodextrin composition comprises agglomerated particles;
- and
- wherein the active agent is pentamidine isethiouate, albuterol sulfate, metaproterenol sulfate, flunisolide, cromolyn sodium, sodium cromoglycate, ergotamine tartrate, levalbuterol, terbutaline, reproterol, salbutamol, salmeterol, formoterol, fenoterol, clenbuterol, bambuterol, tulobuterol, broxaterol, epinephrine, isoprenaline hexoprenaline, or a combination thereof.
Dependencies are inferred from the claim text.