Patents Assigned to Catalent U.K. Swindon Zydis Limited
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Patent number: 11026883Abstract: Disclosed herein is a solid lyophilized vaginal dosage form that can have an effective amount of at least one active ingredient, a crystalline structure forming agent in an amount of about 5 wt. % to about 40 wt. %, based on the total weight of the lyophilized dosage form, and at least one polymeric mucoadhesive matrix forming agent. The dosage form can have a pH of about 4.0 to 5.0, and can disintegrate within 120 seconds after being contacted with a vaginal mucosa. A method of delivering an active ingredient to the vaginal mucosa using the disclosed solid dosage form is also described.Type: GrantFiled: October 13, 2017Date of Patent: June 8, 2021Assignee: Catalent U.K. Swindon Zydis LimitedInventors: Emilie Masto, Lisa Garrett, Niamh Barrat, Yik Teng Wong, Rosaleen Theresa McLaughlin, Susan Gerrard Banbury
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Patent number: 11026892Abstract: Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions using solventless mixing methods. Excess coating material that is not bound to a coated API particle may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Specifically, a coating ratio and/or a dosing ratio can be used to minimize the residual amount of excess unbound coating material to minimize agglomeration of coating material during storage. In some embodiments, a pharmaceutical composition is provided, the pharmaceutical composition comprising: 65-85% w/w API particles; 15-30% w/w coating material coating the API particles; and 3-15% w/w matrix surrounding the coated API particles, wherein the pharmaceutical composition comprises a disintegration time rate of less than 10 seconds for at least six months under storage conditions of at least 25° C. and at least 60% relative humidity.Type: GrantFiled: August 31, 2020Date of Patent: June 8, 2021Assignee: Catalent U.K. Swindon Zydis LimitedInventors: Rosaleen McLaughlin, Simon Andrew Martyn Howes, Craig Wheadon, Jonathon Whitehouse
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Patent number: 10988638Abstract: The present disclosure is directed to processes for reducing the endotoxin level in gelatin and the resulting gelatin with low endotoxin content. The process includes dissolving a salt in a gelatin solution and filtering the gelatin-salt solution using anion exchange to reduce the endotoxin level. After reducing the endotoxin level of the gelatin-salt solution, the low endotoxin gelatin-salt solution is desalted to remove the salt, thereby producing a low endotoxin gelatin solution.Type: GrantFiled: March 7, 2019Date of Patent: April 27, 2021Assignee: Catalent U.K. Swindon Zydis LimitedInventors: Yik Teng Wong, Khojasteh Shirkhani, Ami Powe, Sarah Stewart, Charli Smardon
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Publication number: 20210030623Abstract: Provided are systems and method for dosing a pharmaceutical formulation. These methods and systems can displace the pharmaceutical formulation through a density flow meter, wherein the density flow meter is configured to measure a density of the pharmaceutical formulation. Next, the pharmaceutical formulation can be dosed into preformed molds and the dosing process can be stopped when the density of the pharmaceutical formulation measured by the density flow meter is below a predetermined threshold.Type: ApplicationFiled: July 30, 2020Publication date: February 4, 2021Applicant: Catalent U.K. Swindon Zydis LimitedInventors: David WADDINGTON, Matthew WORT, Katherine ARNEIL
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Publication number: 20200390716Abstract: Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions comprising Ibuprofen using solventless mixing methods. Excess coating material that is not bound to coated Ibuprofen may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Additionally, the compositions can be formulated to preserve the functional coating of coated Ibuprofen and to minimize aeration of Ibuprofen when mixed into suspension.Type: ApplicationFiled: August 31, 2020Publication date: December 17, 2020Applicant: Catalent U.K. Swindon Zydis LimitedInventors: Rosaleen MCLAUGHLIN, Simon Andrew Martyn HOWES, Craig WHEADON, Jonathon WHITEHOUSE, Adam PARKER
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Publication number: 20200390704Abstract: Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions using solventless mixing methods. Excess coating material that is not bound to a coated API particle may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Specifically, a coating ratio and/or a dosing ratio can be used to minimize the residual amount of excess unbound coating material to minimize agglomeration of coating material during storage. In some embodiments, a pharmaceutical composition is provided, the pharmaceutical composition comprising: 65-85% w/w API particles; 15-30% w/w coating material coating the API particles; and 3-15% w/w matrix surrounding the coated API particles, wherein the pharmaceutical composition comprises a disintegration time rate of less than 10 seconds for at least six months under storage conditions of at least 25° C. and at least 60% relative humidity.Type: ApplicationFiled: August 31, 2020Publication date: December 17, 2020Applicant: Catalent U.K. Swindon Zydis LimitedInventors: Rosaleen MCLAUGHLIN, Simon Andrew Martyn HOWES, Craig WHEADON, Jonathon WHITEHOUSE
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Publication number: 20200268667Abstract: Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions using solventless mixing methods. Excess coating material that is not bound to a coated API particle may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Specifically, a coating ratio and/or a dosing ratio can be used to minimize the residual amount of excess unbound coating material to minimize agglomeration of coating material during storage. In some embodiments, a pharmaceutical composition is provided, the pharmaceutical composition comprising: 65-85 % w/w API particles; 15-30 % w/w coating material coating the API particles; and 3-15 % w/w matrix surrounding the coated API particles, wherein the pharmaceutical composition comprises a disintegration time rate of less than 10 seconds for at least six months under storage conditions of at least 25° C. and at least 60 % relative humidity.Type: ApplicationFiled: February 21, 2020Publication date: August 27, 2020Applicant: Catalent U.K. Swindon Zydis LimitedInventors: Rosaleen MCLAUGHLIN, Simon Andrew Martyn HOWES, Craig WHEADON, Jonathon WHITEHOUSE
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Publication number: 20200268676Abstract: Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions comprising Ibuprofen using solventless mixing methods. Excess coating material that is not bound to coated Ibuprofen may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Additionally, the compositions can be formulated to preserve the functional coating of coated Ibuprofen and to minimize aeration of Ibuprofen when mixed into suspension.Type: ApplicationFiled: February 21, 2020Publication date: August 27, 2020Applicant: Catalent U.K. Swindon Zydis LimitedInventors: Rosaleen MCLAUGHLIN, Simon Andrew Martyn HOWES, Craig WHEADON, Jonathon WHITEHOUSE, Adam PARKER
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Publication number: 20200268668Abstract: Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions that preserve the coating of coated API particles in a pharmaceutical suspension. Pharmaceutical compositions include coated active pharmaceutical ingredient (API) particles comprising: an API particle; a first coating comprising one or more deformed components coating the API particle; a second coating comprising silica surrounding and/or partially or fully embedded into the first coating, a matrix former, and a structure former.Type: ApplicationFiled: February 21, 2020Publication date: August 27, 2020Applicant: Catalent U.K. Swindon Zydis LimitedInventors: Rosaleen MCLAUGHLIN, Adam PARKER, Jonathon WHITEHOUSE
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Publication number: 20200268677Abstract: Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions that can minimize the aeration a pharmaceutical suspension during the production process. Pharmaceutical compositions include a plurality of API particles; a coating material encapsulating each API particle of the plurality of API particles; and a matrix solution/suspension comprising a matrix former, a structure former, and an anti-aerating agent.Type: ApplicationFiled: February 21, 2020Publication date: August 27, 2020Applicant: Catalent U.K. Swindon Zydis LimitedInventors: Rosaleen MCLAUGHLIN, Simon Andrew Martyn HOWES, Jonathon WHITEHOUSE
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Publication number: 20200170933Abstract: The present disclosure is directed to oral vaccine dosage forms and processes for producing the oral vaccine dosage forms. The dosage forms include lipid-based vesicles (e.g., virosomes, liposomes) harboring an immunogenic amount of at least one vaccinal target molecule, with or without adjuvant. Specifically, Applicants discovered a combination of the composition of the liquid virosome concentrates, the composition of the base matrix for the solid dosage form formulation (excluding the virosome concentrate), and the manufacturing conditions for the dosage forms that can produce a freeze dried sublingual dosage form having physical robustness, particle and antigen integrity and stability.Type: ApplicationFiled: November 26, 2019Publication date: June 4, 2020Applicants: Catalent U.K. Swindon Zydis Limited, Mymetics CorporationInventors: Yik Teng WONG, Charli SMARDON, Khojasteh SHIRKHANI, Mario AMACKER, Sylvain FLEURY, Antonius Johannes Henrikus STEGMANN
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Publication number: 20200138721Abstract: Described herein is a method for forming multi-layer drug dosage forms having at least two layers. In the method, a first formulation comprising a non-gelling matrix forming agent and having a first density is dosed into a preformed mold. A second formulation comprising a non-gelling matrix former and having a second density not equal to the first density is subsequently dosed into the preformed mold. Then, the combination of the formulations dosed into the mold is freeze dried to form the multi-layer dosage form having at least two layers. The use of a density difference between the first and second formulations ensures formation of a product with two distinct layers.Type: ApplicationFiled: October 25, 2017Publication date: May 7, 2020Applicant: Catalent U.K. Swindon Zydis LimitedInventors: Leon Paul GROTHER, Keiko TSUTSUMI, Rosaleen Theresa MCLAUGHLIN, Yik Teng WONG
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Publication number: 20190314274Abstract: Disclosed herein is a solid lyophilized vaginal dosage form that can have an effective amount of at least one active ingredient, a crystalline structure forming agent in an amount of about 5 wt. % to about 40 wt. %, based on the total weight of the lyophilized dosage form, and at least one polymeric mucoadhesive matrix forming agent. The dosage form can have a pH of about 4.0 to 5.0, and can disintegrate within 120 seconds after being contacted with a vaginal mucosa. A method of delivering an active ingredient to the vaginal mucosa using the disclosed solid dosage form is also described.Type: ApplicationFiled: October 13, 2017Publication date: October 17, 2019Applicant: Catalent U.K. Swindon Zydis LimitedInventors: Emilie MASTO, Lisa GARRETT, Niamh BARRAT, Yik Teng WONG, Rosaleen Theresa MCLAUGHLIN, Susan Gerrard BANBURY
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Publication number: 20190276707Abstract: The present disclosure is directed to processes for reducing the endotoxin level in gelatin and the resulting gelatin with low endotoxin content. The process includes dissolving a salt in a gelatin solution and filtering the gelatin-salt solution using anion exchange to reduce the endotoxin level. After reducing the endotoxin level of the gelatin-salt solution, the low endotoxin gelatin-salt solution is desalted to remove the salt, thereby producing a low endotoxin gelatin solution.Type: ApplicationFiled: March 7, 2019Publication date: September 12, 2019Applicant: Catalent U.K. Swindon Zydis LimitedInventors: Yik Teng WONG, Khojasteh SHIRKHANI, Ami HITCHING, Sarah STEWART