Patent classifications
A61K9/1617
COMPOSITION COMPRISING AT LEAST ONE DRY POWDER OBTAINED BY SPRAY DRYING TO INCREASE THE STABILITY OF THE FORMULATION
The present invention relates to inhalation formulations of drugs in the form of dry powder for inhalation administration deliverable as such with an inhaler and provided with high deliverability, respirability and stability. In particular, the invention relates to a pharmaceutical composition for inhalation use in powder form comprising a first powder comprising at least a powder (a1) comprising an active agent or a pharmaceutically acceptable salt thereof, in an amount greater than 1% by weight of the powder, leucine in an amount from 5 to 70% by weight of said powder, a sugar in an amount from 20 to 90% by weight of the powder;
and a second powder comprising a mixture of a first lactose which has an X50 from 35 to 75 μm, with a second lactose which has an X50 from 1.5 to 10 μm, the content of the first and second lactose in the mixture are respectively from 85% to 96% and from 4% to 15%. The ratio by weight between the first powder and the second powder is from 1/5 to 1/100, and the composition has a fine particle fraction (FPF) greater than 60% and a delivered fraction (DF) greater than 85%.
Pharmaceutical Composition Comprising Dabigatran Etexilate, And Preparation Method, Solid Preparation And Use Thereof
A pharmaceutical composition comprising dabigatran etexilate, and preparation method and use thereof, and solid preparation comprising the pharmaceutical composition; the pharmaceutical composition comprises a vitamin C layer and a dabigatran etexilate layer separated by a semipermeable film layer, and the semipermeable film layer comprises a water-soluble compound, a water-insoluble compound and an optional anti-sticking agent and/or plasticizer.
PROBIOTIC THERAPEUTIC APPLICATIONS
Aspects of the present invention are related to the use of Lactobacillus species in a composition for respiratory administration to prevent the pathogenic inflammatory sequelae of respiratory virus infections.
STABLE SOLID LIPID PARTICLE COMPOSITION FOR IMPROVED BIOAVAILABILITY OF LIPOPHILIC COMPOUNDS FOR AGE-RELATED DISEASES
The present invention provides a delivery system which improves the stability, solubility and permeability of certain types of biologically active compounds in the gut after oral consumption. The delivery system comprises carrier granule comprising an agglomeration of solid lipid particles and a biologically active compound. The biologically active compound may be used with the delivery system to treat illnesses relating to inflammation, oxidation, or protein aggregation where a therapeutic blood and tissue level is required for treating the illness.
EXTENDED RELEASE COMPOSITIONS COMPRISING TRIHEXYPHENIDYL
The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising at least one organic acid; at least one drug layer comprising trihexyphenidyl or a pharmaceutically acceptable salt thereof over the core; and a functional coat over the drug-layered core. The compositions of the disclosure provide extended release with reduced C.sub.max, a C.sub.min:C.sub.max ratio of ≥0.4, Fluctuation Index of ≤1, while providing and maintaining at least a minimum therapeutically effective plasma concentration, of the trihexyphenidyl or the pharmaceutically acceptable salt thereof for at least about 10 hours. The compositions of the disclosure improve solubility of the trihexyphenidyl or the pharmaceutically acceptable salt thereof at a pH of greater than or equal to 5, to provide and maintain at least a minimum effective concentration of the drug at such pH.
(citric) acid/maltodextrin co-agglomerate
Methods of making and resultant acidulent/carbohydrate agglomerates. The acidulent may be citric acid having particle sizes ranging from about 1 micron to 20 microns agglomerated with a soluble carbohydrate co-agglomerate to formulate the various acidulent/carbohydrate agglomerates. In certain embodiments, the carbohydrate co-agglomerate may be maltodextrin to formulate citric acid/maltodextrin agglomerates. These citric acid/maltodextrin agglomerates are shelf stable when dry, have improved flowability, compressibility, mixability; dissolve easily and quickly in water; and provide an easy ready-to-use formulation that is suitable for use in compounding various food and pharmaceutical products.
PHARMACEUTICAL COMPOSITION CONTAINING BUDESONIDE AND FORMOTEROL
The present invention relates to inhalation formulations of drugs in the form of dry powder for inhalation administration, suitable for the treatment of obstructive diseases of the airways, such as asthma and chronic obstructive pulmonary disease (COPD). In particular, the invention relates to a pharmaceutical composition for inhalation comprising a first powder comprising budesonide or a pharmaceutically acceptable salt thereof, in an amount greater than 5% by weight of said first powder, leucine in an amount from 5 to 70% by weight of said first powder, lactose in an amount from 20 to 90% by weight of said first powder; a second powder comprising formoterol or a pharmaceutically acceptable salt thereof, in an amount greater than 1% by weight of said second powder, leucine in an amount from 5 to 70% by weight of said second powder, lactose in an amount from 20 to 90% by weight of said second powder and a third powder comprising a mixture of a first lactose which has an X50 from 35 to 75 μm, with a second lactose which has an X50 from 1.5 to 10 μm, the content of said first and second lactose in said mixture being respectively from 85% to 96% and from 4% to 15%. Said composition has a fine particle fraction (FPF) greater than 60% and a delivered fraction (DF) greater than 80%.
SOLID COMPOSITIONS COMPRISING A GLP-1 AGONIST AND HISTIDINE
The invention relates to stabilised solid pharmaceutical compositions comprising a GLP-1 agonist. The invention further relates to processes for the preparation of such compositions, and their use in medicine.
LIQUISOLID PHARMACEUTICAL FORMULATION AND PROCESS FOR MANUFACTURING
The present invention relates to a liquisolid pharmaceutical formulation comprising a porous carrier and an active pharmaceutical ingredient loaded onto a surface of the porous carrier, wherein the active pharmaceutical ingredient is dispersed in propylene carbonate or a mixture of propylene carbonate and a further solvent and the dispersion of the active pharmaceutical ingredient and propylene carbonate or a mixture of propylene carbonate and a further solvent is loaded onto the external surface and the internal surface located inside the pores of the porous carrier thereby forming a liquisolid system, and to a process for manufacturing such a liquisolid pharmaceutical formulation.
SYSTEMIC FORMULATION OF A PYRIDINONE DERIVATE FOR COELIAC DISEASE
The present invention relates to a systemic formulation, in particular an oral formulation, for the prophylaxis and/or treatment of coeliac disease, i.e. for use in the prophylaxis and/or treatment of coeliac disease.