Rutgers, the State University of New Jersey

Merck + Co., Inc.

New Jersey Institute of Technology

Fernando J Muzzio

Dean Brone

Carolyn Wightman

Priscilla A Robinson

Plamen I Grigorov

Benjamin J Glasser

James A Searles

Joye L Bramble

Richard E Riman

Rajesh N Dave

Michael Joseph Roddy

Lev Tsygan

Semen Dukler

Ecevit A Bilgili

Boris Khusid

Anagha A Bhakay

Erinn K Gleason

Kevin Connor

David J Lamberto

Paul R Mort

Ramani Susarla

Albert Alexander

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%.

Formulation and manufacture of pharmaceuticals by impregnation onto porous carriers

The present disclosure provides improved stripfilm based pharmaceutical products (e.g., for enhancing dissolution and bioavailability). More particularly, the present disclosure provides improved systems/methods for fabricating stripfilm based pharmaceutical products by utilizing higher viscosity film forming precursors and drying methods that accomplish improved/faster drying and provide improved/excellent content uniformity of active pharmaceutical agents in the stripfilm based pharmaceutical products. Exemplary systems/methods advantageously use high viscosity, bio-compatible polymeric precursors, (optional use of surface modified drug powders), and convective drying for fabrication of thin films loaded with nano and/or micro sized particles of poorly water-soluble active pharmaceutical ingredients (APIs) to achieve improved active content uniformity and very fast dissolution from poorly water soluble actives, while accomplishing fast drying during the fabrication process. The present disclosure provides for the fast drying (e.g., via low temperature forced convection) of biocompatible polymer films loaded with poorly water-soluble drug nano-particles.

System and method for fabrication of uniform polymer films containing nano and micro particles via continuous drying process

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.

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.

Uniform shear application system and methods relating thereto

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.

Powder sampling method and apparatus

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.

Method of improved mixing of a varicella-infected cell culture in roller bottles

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.

Method of improved mixing in roller bottles

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.

End-sampling thief probe

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. For both particle sizes, the extent of mixing was greatly enhanced using the rocking V-blender compared to the conventional V-blender.

Dynamically enhanced V-blender

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.

Method of chaotic mixing and improved stirred tank reactors

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.

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Sparta, NJ, United States of America

Fernando J Muzzio