Abstract

Methods for screening pancrelipase for RNA virus contamination comprise removing free viral RNA from the pancrelipase, denaturing any viruses in the pancrelipase to release encapsidated RNA into the pancrelipase milieu, and detecting this released RNA. Removal of free viral RNA may comprise treating pancrelipase with RNase and DNase or precipitating the protein fraction of pancrelipase with a salt that precipitates the protein fraction while leaving nucleic acids such as RNA in solution. Pancrelipase substantially devoid of free nucleic acid is also provided.

IPC Classes  ?

• A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
• C12N 9/94 - Pancreatin

Abstract

The present disclosure provides high potency pharmaceutical compositions comprising high activity pancreatin enzymes. The invention is also directed to a process of producing HA- pancreatin enzymes and its compositions or dosage forms, and methods for their use.

IPC Classes  ?

• A61K 38/54 - Mixtures of enzymes or proenzymes covered by more than a single one of groups or

Abstract

The present invention provides high potency pharmaceutical compositions comprising high activity pancreatin enzymes. The invention is also directed to a process of producing HA- pancreatin enzymes and its compositions or dosage forms, and methods for their use.

IPC Classes  ?

• A61K 38/46 - Hydrolases (3)
• A61K 38/48 - Hydrolases (3) acting on peptide bonds (3.4)
• C12N 9/94 - Pancreatin
• A61P 1/18 - Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes

Abstract

The present invention provides a process for the preparation of a stable and homogeneous liquid composition that is suitable for enteral administration comprising a digestive enzyme product and nutrients from a nutritional formula having specific amount of nutrients. The invention further provides a method for efficiently and effectively administering a therapeutically effective dose of the stable and homogeneous liquid composition by means of an enteral tube.

IPC Classes  ?

• A61K 38/46 - Hydrolases (3)
• A61K 47/06 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
• A23L 1/29 - Modifying nutritive qualities of foods; Dietetic products ( A23L 1/09 takes precedence;dietetic salt substitutes A23L 1/22)
• A23L 1/30 - containing additives (A23L 1/308 takes precedence);;
• A61K 38/47 - Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• A61K 38/48 - Hydrolases (3) acting on peptide bonds (3.4)
• C12N 9/26 - Hydrolases (3.) acting on glycosyl compounds (3.2) acting on alpha-1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase

Abstract

The invention is directed to a process for measuring the amount of digestive enzymes released from a solid composition in a dissolution medium by fluorescence spectroscopy. The invention is also directed to a combined method for measuring both the dissolution and gastroresistance of a solid compositions comprising pancrelipase.

IPC Classes  ?

• A61K 38/46 - Hydrolases (3)
• C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
• G01N 33/15 - Medicinal preparations

Abstract

The invention provides a composite of drug, polymeric carrier and at least one not cross linked polymer useful to improve the solubility of poorly water soluble drugs. The present invention comprises manufacturing process of this composite material. The manufacturing process is carried out by the solvent induced activation process, wherein the not cross-linked polymer is loaded into the composite from organic solution, possibly together with the drug. Pharmaceutical compositions comprising said composite in combination with pharmaceutical acceptable excipients are also described herein.

IPC Classes  ?

• A61K 9/14 - Particulate form, e.g. powders
• A61K 31/18 - Sulfonamides
• A61K 31/216 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
• A61K 31/44 - Non-condensed pyridinesHydrogenated derivatives thereof

Abstract

A device for administering orally particles of medication and a liquid to a patient. In a first embodiment, the device has a medicine chamber and a liquid chamber. In a second embodiment, the device has a package and an ampoule. The device assures safe and relatively long-term storage of a medicinal product; provides an administration vehicle; prepares particles of medication suspended in a liquid; and improves patient compliance. A method of administering the medication entails using the disclosed devices.

IPC Classes  ?

• A61J 7/00 - Devices for administering medicines orally, e.g. spoonsPill counting devicesArrangements for time indication or reminder for taking medicine
• A61J 11/00 - Teats

Abstract

The present invention is directed to a pharmaceutical composition or dosage form having a stable, low (diluted) digestive en2yme content comprising at least one digestive enzyme and at least one carrier, or a dosage form thereof. The invention is also directed to a process of preparation of the composition or the dosage form. In addition the invention is directed to the treatment and prevention of disorders or conditions associated with a digestive enzyme deficiency in a patient in need thereof, comprising administering to said patient a pharmaceutically acceptable amount of the composition having a stable low digestive enzyme content or dosage form thereof.

IPC Classes  ?

• A61K 9/20 - Pills, lozenges or tablets
• A61K 9/28 - DrageesCoated pills or tablets
• A61K 38/43 - EnzymesProenzymesDerivatives thereof

Abstract

The present invention is directed to a process for the preparation of a predigested nutritional formula as well as the predigested liquid nutritional formula and a kit for the preparation of a predigested nutritional formula. The predigested nutritional formula comprises digestive enzymes and a liquid nutritional composition comprising a mixture of carbohydrates, lipids, proteins and water.

IPC Classes  ?

• A23F 3/16 - Tea extractionTea extractsTreating tea extractMaking instant tea
• A23K 3/00 - Processes specially adapted for preservation of materials in order to produce animal feeding-stuffs

Abstract

The present invention relates to a small particle size composition comprising pancreatin containing digestive enzymes for use in patients in need, including pediatric, geriatric, and adult patients, particularly those patients with dysphagia or wherein enteral administration using such composition would be suitable. In addition, the invention is directed to the composition as particles, such as micropellets or microgranules having a high potency, high useable yield and at least 10% - 90% of 400-800 µm. Furthermore, the composition optionally has an improved enteric coating and concomitant improved stability and enzyme activity compared to conventional prepared enterically coated pancreatic enzyme particles.

IPC Classes  ?

• A61K 9/26 - Discrete particles in supporting matrix

Abstract

A syringe and filter cap ease the administration of medication to patients. The cap fits securely over the syringe nozzle and has at least one orifice. The orifice is configured to retain medication particles within the syringe, while allowing liquid to be drawn into the syringe through the cap. A kit combines the medication, the syringe and its plunger, the cap, and a liquid holder cup. The method of administering the medication entails: (a) removing the plunger from the syringe, (b) placing the cap over the nozzle, (c) inserting the particulate medication into the syringe, (d) re-inserting the plunger into the syringe, (e) drawing the desired amount of liquid into the syringe through the cap, thereby suspending the particulate medication within the liquid drawn into the syringe, (f) removing the cap from the syringe, and (g) delivering the medication dosage to the patient.

IPC Classes  ?

• A61J 7/00 - Devices for administering medicines orally, e.g. spoonsPill counting devicesArrangements for time indication or reminder for taking medicine
• A61J 1/20 - Arrangements for transferring fluids, e.g. from vial to syringe
• A61J 11/00 - Teats
• A61M 5/31 - Syringes Details

Abstract

The present invention provides a pharmaceutical composition comprising taste-masked immediate release microcapsules which comprise fexofenadine and a water-insoluble polymer coating. These microcapsules and the pharmaceutical compositions comprising them have suitable drug content and desirable pharmaceutical properties, including a quick dissolution rate of fexofenadine combined with a taste masking effect.

IPC Classes  ?

• A61K 9/50 - Microcapsules
• A61K 31/445 - Non-condensed piperidines, e.g. piperocaine