Catalent U.k. Swindon Zydis Limited

Rosaleen McLaughlin

Jonathon Whitehouse

Simon Andrew Martyn Howes

Craig Wheadon

Adam Parker

Yik Teng Wong

Leon Grother

Susan Gerrard Banbury

Lisa Garrett

Niamh Barrat

Keiko Tsutsumi

Emilie Masto

Michael John Hutchinson

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.

Minimizing agglomeration of drug particle coating material during storage to stabilize disintegration times of pharmaceutical products

Provided are methods of making a pharmaceutical composition comprising: providing a matrix solution/suspension comprising a matrix former, a structure former, 0.1-1.5 wt. % anti-aerating agent, and a solvent; mixing a plurality of hydrophobic particles into the matrix solution/suspension to form a pharmaceutical suspension; and dosing the pharmaceutical suspension into preformed blister packs, wherein a dosed weight of the dosed pharmaceutical suspension is within 10 % of a target dosed weight.

Minimizing aeration of suspensions during in-line mixing

Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions comprising coated API. Excess coating material that is not bound to coated API 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 API and to minimize aeration of API when mixed into suspension.

Pharmaceutical compositions comprising coated API

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.

Preserving functionally-coated API particles produced by solventless mixing processes in aqueous suspension

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.

Minimizing agglomeration, aeration, and preserving the coating of pharmaceutical compositions comprising ibuprofen

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&#xb0; C. and at least 60% relative humidity.

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.

Compositions of different densities for fast disintegrating multi-layer tablet

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&#xb0; C. and at least 60 % relative humidity.

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.

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Swindon, United Kingdom

Rosaleen McLaughlin