Patents Assigned to Aptalis Pharma Limited
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Patent number: 8889182Abstract: The present invention refers to a process to prepare a highly activated composite of one or more water-insoluble drugs, said process comprising the steps of: (a) subjecting said water-insoluble drug and a cross-linked polymer to co-grinding; (b) exposing the ground product of step a. to contact with water or water vapors. The resulting composite contains large amounts of drug in the easily soluble amorphous form, reduced amounts of drug in the nanocrystalline form, and is substantially free from practically insoluble drug crystals.Type: GrantFiled: June 3, 2002Date of Patent: November 18, 2014Assignee: Aptalis Pharma LimitedInventors: Massimo Bresciani, Lorenzo Magarotto, Luca Dobetti
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Publication number: 20140141091Abstract: 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.Type: ApplicationFiled: October 9, 2013Publication date: May 22, 2014Applicant: APTALIS PHARMA LIMITEDInventors: Luigi Mapelli, Flavio Fabiani, Luigi Boltri, Paolo Gatti, Mauro Serratoni, Roberto Cassanmagnago
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Patent number: 8722096Abstract: Lipoic acid pellets are described, obtained from inert cores externally coated with lipoic acid. The so obtained active cores are coated with a first layer of insulating polymeric material and then with a polymeric coat that is insoluble at the gastric pH. Pellet are then formulated pharmaceutically, for instance in jelly capsules or controlled release capsules or as oral suspensions, dispersible powders, sachets, etc.Type: GrantFiled: May 25, 2007Date of Patent: May 13, 2014Assignees: Aptalis Pharma Limited, Laboratorio Chimico Internazionale S.p.A.Inventors: Luigi Boltri, Flavio Fabiani, Luigi Mapelli, Annibale Salvi, Paolo Magri', Antonio Nardi, Flavio Villani
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Publication number: 20140127307Abstract: 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 ?m. 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.Type: ApplicationFiled: November 2, 2012Publication date: May 8, 2014Applicant: APTALIS PHARMA LIMITEDInventors: Gopi M. VENKATESH, Craig Kramer, Flavio Fabiani, Luigi Mapelli, Giovanni Ortenzi, Massimo Latino
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Patent number: 8580313Abstract: 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.Type: GrantFiled: December 2, 2010Date of Patent: November 12, 2013Assignee: Aptalis Pharma LimitedInventors: Luigi Mapelli, Flavio Fabiani, Luigi Boltri, Paolo Gatti, Mauro Serratoni, Roberto Cassanmagnago
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Patent number: 8562978Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.Type: GrantFiled: July 8, 2010Date of Patent: October 22, 2013Assignee: Aptalis Pharma LimitedInventors: Giovanni Ortenzi, Marco Marconi, Luigi Mapelli
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Patent number: 8562980Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.Type: GrantFiled: February 2, 2011Date of Patent: October 22, 2013Assignee: Aptalis Pharma LimitedInventors: Giovanni Ortenzi, Marco Marconi, Luigi Mapelli
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Patent number: 8562981Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.Type: GrantFiled: February 2, 2011Date of Patent: October 22, 2013Assignee: Aptalis Pharma LimitedInventors: Giovanni Ortenzi, Marco Marconi, Luigi Mapelli
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Patent number: 8562979Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.Type: GrantFiled: February 2, 2011Date of Patent: October 22, 2013Assignee: Aptalis Pharma LimitedInventors: Giovanni Ortenzi, Marco Marconi, Luigi Mapelli
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Publication number: 20130274297Abstract: 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.Type: ApplicationFiled: December 22, 2011Publication date: October 17, 2013Applicant: APTALIS PHARMA LIMITEDInventors: Paolo Gatti, Italo Colombo, Dario Gervasoni, Vincenza Pironti, Lia Alborghetti, Flavio Fabiani, Luigi Boltri
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Publication number: 20130156934Abstract: Microcapsules containing an active ingredient, constituted by a core coated with a polymer membrane, characterized in that the active ingredient is incorporated in the polymer coating layer, and in that said layer is applied using microencapsulation techniques (coacervation by means of phase separation). The microcapsules; thus produced have excellent properties of taste masking and prolonged release of the active ingredients.Type: ApplicationFiled: November 20, 2012Publication date: June 20, 2013Applicant: APTALIS PHARMA LIMITEDInventor: APTALIS PHARMA LIMITED
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Patent number: 8293229Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.Type: GrantFiled: February 20, 2008Date of Patent: October 23, 2012Assignee: Aptalis Pharma LimitedInventors: Giovanni Ortenzi, Marco Marconi, Luigi Mapelli
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Patent number: 8246950Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.Type: GrantFiled: February 20, 2008Date of Patent: August 21, 2012Assignee: Aptalis Pharma LimitedInventors: Giovanni Ortenzi, Marco Marconi, Luigi Mapelli
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Publication number: 20120201875Abstract: The present invention is directed to a pharmaceutical composition or dosage form having a stable, low (diluted) digestive enzyme 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.Type: ApplicationFiled: October 3, 2011Publication date: August 9, 2012Applicant: Aptalis Pharma LimitedInventors: Giovanni ORTENZI, Giuseppe De Franza, Danilo Clementi, Christian Stollberg, Luigi Boltri
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Patent number: 8221747Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.Type: GrantFiled: February 20, 2008Date of Patent: July 17, 2012Assignee: Aptalis Pharma LimitedInventors: Giovanni Ortenzi, Marco Marconi, Luigi Mapelli
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Publication number: 20120177629Abstract: 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.Type: ApplicationFiled: August 8, 2011Publication date: July 12, 2012Applicant: Aptalis Pharma LimitedInventors: Delma Broussard, Luigi Ghidorsi, Giovanni Ortenzi