Abrégé

The invention relates to an aqueous solution comprising burlulipase, characterized in that the solution contains calcium ions. The invention further relates in particular to corresponding medicaments. Such medicaments suitable for treating exocrine pancreatic insufficiency. This medicament is in particular suitable for treating patients having cystic fibrosis and in pediatrics. A further aspect of the invention relates to solutions and medicaments packaged in containers as recited above, wherein these are containers which are produced by means of the blow-fill-seal process, and to methods for producing such packaged solutions and medicaments.

Classes IPC  ?

• A61K 9/08 - Solutions
• A61K 47/02 - Composés inorganiques
• A61K 38/46 - Hydrolases (3)

Abrégé

The invention relates to an orodispersible tablet that is characterized in that said orodispersible tablet comprises burlulipase. The invention further relates to liquid pharmaceutical compositions that contain solutions of such orodispersible tablets in water or other beverages. The invention relates to drugs that contain or consist of such orodispersible tablets or solutions. In particular, the invention relates to such drugs that are suitable for treating digestive problems, in particular exocrine pancreatic insufficiency. In particular, said drugs are suitable for treating exocrine pancreatic insufficiency in patients having mucoviscidosis and for treating exocrine pancreatic insufficiency of patients in pediatrics.

Classes IPC  ?

• A61K 9/20 - Pilules, pastilles ou comprimés
• A61K 38/16 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés
• A61K 9/10 - DispersionsÉmulsions
• A61K 9/107 - Émulsions
• A61K 47/46 - Ingrédients de constitution indéterminée ou leurs produits de réaction, p. ex. peau, os, lait, fibre de coton, coquille d’œuf, fiel de bœuf ou extraits de plante
• A61P 1/18 - Médicaments pour le traitement des troubles du tractus alimentaire ou de l'appareil digestif des troubles pancréatiques, p. ex. enzymes pancréatiques

Abrégé

The invention relates to a pharmaceutical composition comprising pancreatin which has a coating containing at least one lipase. Preferably, the least one lipase is burlulipase. The invention also relates to medicaments comprising one such pharmaceutical composition. The invention also relates to a method for producing said type of pharmaceutical composition.

Classes IPC  ?

• A61K 9/20 - Pilules, pastilles ou comprimés
• A61K 38/16 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés
• A61K 38/46 - Hydrolases (3)
• C12N 9/94 - Pancréatine
• A61P 1/18 - Médicaments pour le traitement des troubles du tractus alimentaire ou de l'appareil digestif des troubles pancréatiques, p. ex. enzymes pancréatiques

Abrégé

The invention relates to a pharmaceutical composition in combination with a tube feed intended for artificial feeding in the treatment of digestive disorders in artificial feeding, where the pharmaceutical composition comprises or consists of at least one digestive enzyme, preferably a lipase, more preferably a bacterial lipase, very preferably burlulipase (INN) in fluid administration form, with the pharmaceutical composition and the tube feed being formulated for administration simultaneously but separately from one another. The pharmaceutical composition can therefore be administered simultaneously and continuously during administration of the tube feed, but separately from it. As a result, the digestive performance of a patient being artificially fed can successfully be boosted significantly.

Classes IPC  ?

• A61K 38/46 - Hydrolases (3)
• A61K 38/16 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés
• A23L 33/195 - Protéines de micro-organismes
• A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier

Abrégé

The invention relates to a pharmaceutical preparation for treating pancreas insufficiency, comprising a liquid application form of enzymes.

Classes IPC  ?

• A61K 38/46 - Hydrolases (3)
• A61P 1/18 - Médicaments pour le traitement des troubles du tractus alimentaire ou de l'appareil digestif des troubles pancréatiques, p. ex. enzymes pancréatiques

Abrégé

The invention relates to a method for reducing the viral and microbial load of biological extracts containing solids. According to the invention, the method comprises the steps: (a) preparing the biological extract containing solids, comprising at least one biologically active substance, selected from enzymes, proteins, and peptides, or a mixture of such active substances; and (b) exposing the extract prepared in step (a) to a high-pressure treatment, wherein the biological activity of the biological extract containing solids after the high-pressure treatment is at least 50% of the biological activity of the biological extract containing solids prior to the high-pressure treatment, and the viral infectiousness of the biological extract containing solids after the high-pressure treatment has been reduced by a factor of greater than 1 log10 relative to the viral infectiousness of the biological extract containing solids prior to the high-pressure treatment.

Classes IPC  ?

• A61L 2/00 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet
• C07K 14/435 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
• C12N 9/94 - Pancréatine

Abrégé

The invention relates to a method for reducing the viral and microbial load of biological extracts containing solids. It is provided that the method comprises the steps: (a) preparing the biological extract containing solids, comprising at least one biologically-active active ingredient, selected from enzymes, proteins, and peptides, or a mixture of such active ingredients; and (b) subjecting the extract prepared in step (a) to a high-pressure treatment; wherein the biological activity of the biological extract containing solids after the high-pressure treatment corresponds to at least 50 % of the biological activity of the biological extract containing solids before the high-pressure treatment.

Classes IPC  ?

• A61L 2/00 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet
• C07K 14/435 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
• C12N 9/94 - Pancréatine

Abrégé

The invention relates to a method for reducing the number of viruses and microorganisms in biological extracts containing solids. The method involves the following steps: (a) preparing a biological extract that contains solids and is in the form of a suspension, composed of a liquid phase and of solid particles dispersed in the latter, wherein the extract in step (a) comprises a mixture of enzymes, proteins and peptides, some of which mixture can be dissolved in the liquid phase while the rest can be bound to the solid particles, or is in the form of powdery solid; and (b) irradiating the biological extract prepared in step (a), wherein the radiation used for said irradiation is chosen from the group including ultraviolet radiation, X-radiation, ß-radiation and &ggr;-radiation; and the enzymatic activity of the solids-containing biological extract after the irradiation is at least 50% of the enzymatic activity of the solids-containing biological extract before the irradiation.

Classes IPC  ?

• A61L 2/00 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet
• C07K 14/435 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains