Abstract: The present disclosure relates to a continuous process for melt-coating active pharmaceutical ingredients, including introducing at least one active pharmaceutical ingredient (API) and at least one surfactant into a processor; and continuously and simultaneously heating and shearing the API and surfactant in the processor at a temperature close to the melting point of the surfactant so as to continuously form melt-coated API particles having at least a partial coating of surfactant. The disclosure also relates to melt-coated API particles prepared by the disclosed continuous melt-coating process, and pharmaceutical drug products prepared from such melt-coated API particles.

Abstract: The present disclosure relates to a continuous process for impregnating active pharmaceutical ingredients (API) onto porous carriers, including the steps of introducing a porous carrier into a first feeder; continuously directing the porous carrier from the first feeder into a continuous blender, wherein the continuous blender comprises one or more nozzles; continuously introducing a solution comprising an API dissolved in solvent into the continuous blender through the one or more nozzles to form API-impregnated porous carrier; and continuously drying the API-impregnated porous carrier using a fluidized bed dryer to form a powder. The present disclosure also relates to a continuous process for manufacturing pharmaceutical drug products using continuously manufactured API-impregnated porous carriers. The present disclosure also relates to a continuous pharmaceutical drug manufacturing process that includes API-impregnated porous carriers as a raw material.

Abstract: The present invention provides an impregnated porous carrier material comprising at least one active pharmaceutical ingredient (API) impregnated throughout the internal surface of a porous carrier. The present invention further provides immediate release and sustained release pharmaceutical dosage forms comprising the impregnated porous carrier material disclosed herein such that any single active pharmaceutical ingredient (API) content variability in the finished drug product has a relative standard deviation of less than 3%.

Abstract: The present invention provides an impregnated porous carrier material comprising at least one active pharmaceutical ingredient (API) impregnated throughout the internal surface of a porous carrier. The present invention further provides immediate release and sustained release pharmaceutical dosage forms comprising the impregnated porous carrier material disclosed herein such that any single active pharmaceutical ingredient (API) content variability in the finished drug product has a relative standard deviation of less than 3%.

Abstract: The present invention provides methods for impregnating a porous carrier with an active pharmaceutical ingredient (“AP”), the methods comprising steps: a) dissolving at least one API in a solvent to form an API solution; b) contacting a porous carrier with the at least one API of step (a) in a contactor to form an API impregnated porous carrier; and c) drying the at least one API impregnated porous carrier.

Abstract: The present invention provides methods for impregnating a porous carrier with an active pharmaceutical ingredient (“AP”), the methods comprising steps: a) dissolving at least one API in a solvent to form an API solution; b) contacting a porous carrier with the at least one API of step (a) in a contactor to form an API impregnated porous carrier; and c) drying the at least one API impregnated porous carrier.

Abstract: A manufacturing device capable of creating individualized dosages of pharmaceutical preparations in which a metering system and a means of performing non-destructive chemical analysis of individual manufactured units are controlled by a microprocessor to precisely control the content and structure of each individual unit.

Abstract: Disclosed herein is a shear application system for applying substantially uniform amounts of shear throughout a powder sample. The shear application system preferably includes a cylinder assembly having an inner cylinder, a housing, an inner set of lugs, and an outer set of lugs. The inner cylinder has an external cylindrical surface and the housing has an internal cylindrical surface concentric with said external cylindrical surface. The internal and external cylindrical surfaces form an annular chamber therebetween. Each one of the lugs of the inner set extend radially outward from the external cylindrical surface, and each one of the lugs of the outer set extend radially inward from the internal cylindrical surface and are substantially uniformly spaced. The shear application system preferably includes drive means mechanically connected to the inner cylinder and control means electrically connected to the drive means.

Abstract: Disclosed herein is a shear application system for applying substantially uniform amounts of shear throughout a powder sample. The shear application system preferably includes a cylinder assembly having an inner cylinder, a housing, an inner set of lugs, and an outer set of lugs. The inner cylinder has an external cylindrical surface and the housing has an internal cylindrical surface concentric with said external cylindrical surface. The internal and external cylindrical surfaces form an annular chamber therebetween. Each one of the lugs of the inner set extend radially outward from the external cylindrical surface, and each one of the lugs of the outer set extend radially inward from the internal cylindrical surface and are substantially uniformly spaced. The shear application system preferably includes drive means mechanically connected to the inner cylinder and control means electrically connected to the drive means.

Abstract: Disclosed herein is a shear application system for applying substantially uniform amounts of shear throughout a powder sample. The shear application system preferably includes a cylinder assembly having an inner cylinder, a housing, an inner set of lugs, and an outer set of lugs. The inner cylinder has an external cylindrical surface and the housing has an internal cylindrical surface concentric with said external cylindrical surface. The internal and external cylindrical surfaces form an annular chamber therebetween. Each one of the lugs of the inner set extend radially outward from the external cylindrical surface, and each one of the lugs of the outer set extend radially inward from the internal cylindrical surface and are substantially uniformly spaced. The shear application system preferably includes drive means mechanically connected to the inner cylinder and control means electrically connected to the drive means.

Abstract: A powder sampling method and apparatus is provided for sampling powder from a mixer or a drum. An undisturbed column of powder is extracted from a vessel. The column of powder may then be sectioned into subunits, using a discharge device, providing up to dozens of samples per insertion. Larger number of representative samples of controlled size from a powder bed can be acquired.

Abstract: A powder sampling method and apparatus is provided for sampling powder from a mixer or a drum. An undisturbed column of powder is extracted from a vessel. The column of powder may then be sectioned into subunits, using a discharge device, providing up to dozens of samples per insertion. Larger number of representative samples of controlled size from a powder bed can be acquired.

Abstract: A method for enhancing the mixing of a varicella-infected cell culture in a roller bottle by the introduction of controlled cross-sectional flow perturbations in roller bottle rotation is disclosed. The effectiveness of the method is demonstrated by achieving higher efficiency in cell culturing and virus propagation in roller bottles by introducing controlled cross-sectional flow perturbations during the process.

Abstract: A method for enhancing the mixing of materials in a roller bottle by the introduction of controlled axial and cross-sectional flow perturbations is disclosed. The effectiveness of the method is demonstrated by achieving higher efficiency in cell culturing and virus propagation in roller bottles by introducing controlled flow perturbations during the process.

Abstract: This invention relates to an end-sampling thief probe and a method of using this probe. The thief probe of the invention is useful in extracting a sample with minimal disturbance and provides an improved method for end-sampling.

Abstract: A study was done to compare the performance of a conventional V-blender to a V-blender that incorporates perturbations of the particle flow by rocking the mixing vessel during its normal rotation. Mixing was investigated using glass beads with sizes from 66.mu. to 600.mu. in vessels of approximately one liter volume. Mixture uniformity was assessed qualitatively, using two different methods. One method involved a transparent mixing vessel where it was possible to see particle flow patterns and assess the state of the mixture at its surface during the entire experiment. The second method involved disposable aluminum mixing vessels, where the mixture was solidified by infiltrating the mixture with a binder. By slicing the solidified structure, it was possible to assess the entire state of the mixture including its interior structure after the completion of each experiment. Mixture uniformity was also assessed quantitatively using image analysis of the slices.

Abstract: The invention provides a method and apparatus for efficiently achieving a homogeneous mixture of fluid components by introducing said components having a Reynolds number of between about .ltoreq.1 to about 500 into a vessel and continuously perturbing the mixing flow by altering the flow speed and mixing time until homogeniety is reached. This method prevents the components from aggregating into non-homogeneous segregated regions within said vessel during mixing and substantially reduces the time the admixed components reach homogeneity.

Abstract: A method and apparatus for improved particulate mixing in which rotational motion of a mixing vessel is periodically disrupted by rocking motion. A vessel rotates around a central axis for producing the rotational motion. The vessel is rocked in a direction substantially perpendicular to the central axis for producing rocking motion. Mixing is enhanced when the rocking frequency is different than the rotational frequency.