Abstract: A method of employing a mixture of two different types of silica as a binary dry coating material to benefit properties of fine milled pharmaceuticals, such as ibuprofen, milled to the mean particle size of ˜10 ?m or smaller. Synergistic effects of reduction in agglomerate size, and improved surface wettability was found by employing a mixture of two different types of silica as the dry coating material in specific ratios. The silica used up to weight percent to 2.31 wt % of a minority component, typically an API or excipient. The silica amount in the entire blend was less than 0.1 wt %. The surface coverage of API was optimized to 50%. Properties were increased when surface coverage by binary coating agents was controlled so that no excess coating agent was available to form agglomerates on the surface.

Abstract: High (greater than 30%) and/or low (less than 10%) loaded multiple API powdered/nanoparticle were tabulated with increased flowability and physical properties. Properties include blend flowability and uniformity, bulk packing density, compactability, tensile strength, and dissolution. Blending is done through solventless dry mechanical coating of at least one minority API component defined as the API component with the least weight per volume surface coated with nano-sized powders in lesser amounts by wt % of the blend, and preferably less than 10% dry coated of the minority API. An excipient may be dry coated in the lesser amount wherein the excipient is a minority component. Both minority excipient and minority API may be dry coated. Using dry coating instead of dry granulation and/or wet granulation techniques in producing tablets saves manufacturing steps, costs, and produces higher quality tablets with surprisingly higher properties than expected for low flowability solid powdered ingredients.

Abstract: High(greater than 30%) and/or low(less than 10%) loaded multiple API powdered/nanoparticle were tabulated with increased flowability and physical properties. Properties include blend flowability and uniformity, bulk packing density, compactability, tensile strength, and dissolution. Blending is done through solventless dry mechanical coating of at least one minority API component defined as the API component with the least weight per volume surface coated with nano-sized powders in lesser amounts by wt % of the blend, and preferably less than 10% dry coated of the minority API. An excipient may be dry coated in the lesser amount wherein the excipient is a minority component. Both minority excipient and minority API may be dry coated. Using dry coating instead of dry granulation and/or wet granulation techniques in producing tablets saves manufacturing steps, costs, and produces higher quality tablets with surprisingly higher properties than expected for low flowability solid powdered ingredients.

Abstract: The present disclosure provides improved film based pharmaceutical products containing uniformly distributed drug or active agent particles (e.g., to achieve improved/excellent dissolution control including enhancing dissolution and bioavailability and/or product uniformity). More particularly, the present disclosure provides improved systems/methods for fabricating film based pharmaceutical products by utilizing higher surface modified micronized drug or active agent powders and film forming precursors and drying methods that accomplish improved/efficient drying and provide improved/excellent content uniformity of active pharmaceutical agents in the fabricated film based pharmaceutical products. In exemplary embodiments, the present disclosure provides for an easier means of directly incorporating dry micronized poorly water-soluble drugs or active agent particles (e.g., fenofibrate (“FNB”)) into films.

Abstract: Pharmaceutical blends are disclosed herein. In some embodiments, a pharmaceutical blend includes a cohesive active pharmaceutical ingredient (API) and a dry coated pharmaceutical excipient. The dry coated pharmaceutical excipient is present in an amount of about 1 wt % to 99 wt %, based on the total weight of the pharmaceutical blend. The dry coated pharmaceutical excipient includes a core and a shell surrounding the core, wherein the shell partially covers the core of the pharmaceutical excipient.

Abstract: 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.

Abstract: The present disclosure provides improved film based pharmaceutical products containing uniformly distributed drug or active agent particles (e.g., to achieve improved/excellent dissolution control including enhancing dissolution and bioavailability and/or product uniformity). More particularly, the present disclosure provides improved systems/methods for fabricating film based pharmaceutical products by utilizing higher surface modified micronized drug or active agent powders and film forming precursors and drying methods that accomplish improved/efficient drying and provide improved/excellent content uniformity of active pharmaceutical agents in the fabricated film based pharmaceutical products. In exemplary embodiments, the present disclosure provides for an easier means of directly incorporating dry micronized poorly water-soluble drugs or active agent particles (e.g., fenofibrate (“FNB”)) into films.

Abstract: Pharmaceutical blends are disclosed herein. In some embodiments, a pharmaceutical blend includes a cohesive active pharmaceutical ingredient (API) and a dry coated pharmaceutical excipient. The dry coated pharmaceutical excipient is present in an amount of about 1 wt % to 99 wt %, based on the total weight of the pharmaceutical blend. The dry coated pharmaceutical excipient includes a core and a shell surrounding the core, wherein the shell partially covers the core of the pharmaceutical excipient.

Abstract: 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.

Abstract: The present invention is a solventless method of producing polymer coated active pharmaceutical ingredient that is taste-masked and may be released in relatively short time. It employs high energy vibrations or acoustic mixing of API particles, water soluble coating material particles and hydrophobic polymer particles, with or without use of other pharmaceutically relevant powders as media. Additionally the method is capable of producing individually coated drug particles without agglomeration or the long drying times associated with solvent based coating methods.

Abstract: A taste masked particulate pharmaceutical formulation include a core that comprises an active pharmaceutical ingredient; at least a partial nanoparticle material layer on the core that comprises a nanoparticle material with a median particle size not greater than 100 nm; a first polymer layer that is at least partially water soluble and a second polymer layer that is water insoluble. The active pharmaceutical ingredient is completely released in 30 minutes in the USP Dissolution Test. A process of making the particulate pharmaceutical formulation using sequential fluidized bed coating steps under controlled conditions is also described.

Abstract: A taste masked particulate pharmaceutical formulation include a core that comprises an active pharmaceutical ingredient; at least a partial nanoparticle material layer on the core that comprises a nanoparticle material with a median particle size not greater than 100 nm; a first polymer layer that is at least partially water soluble and a second polymer layer that is water insoluble. The active pharmaceutical ingredient is completely released in 30 minutes in the USP Dissolution Test. A process of making the particulate pharmaceutical formulation using sequential fluidized bed coating steps under controlled conditions is also described.

Abstract: The present invention is a solventless method of producing polymer coated active pharmaceutical ingredient that is taste-masked and may be released in relatively short time. It employs high energy vibrations or acoustic mixing of API particles, water soluble coating material particles and hydrophobic polymer particles, with or without use of other pharmaceutically relevant powders as media. Additionally the method is capable of producing individually coated drug particles without agglomeration or the long drying times associated with solvent based coating methods.

Abstract: With the coupling of an external field and aeration (or a flow of another gas), nanoparticles can be smoothly and vigorously fluidized. A magnetic force and/or pre-treatment may be employed with the fluidizing gas and, when coupled with a fluidizing medium, provide excellent means for achieving homogenous nanofluidization. The magnetic force interacts with non-fluidizing magnetic particles and helps to break channels as well as provide enough energy to disrupt the strong interparticle forces, thereby establishing an advantageous agglomerate size distribution. Enhanced fluidization is reflected by improved performance-related attributes. The fluidized nanoparticles may be coated, surface-treated and/or surface-modified in the fluidized state. In addition, the fluidized nanoparticles may participate in a reaction, either as a reactant or a catalyst, while in the fluidized state.

Abstract: The present disclosure provides for systems and methods for measuring and/or characterizing properties of ultra-fine or cohesive powders. More particularly, the present disclosure provides for systems and methods for measuring and/or characterizing packing density and/or flowability of ultra-fine or cohesive powders using vibrations. In one embodiment, the present disclosure provides for systems and methods for improved characterization or specification of powder or packing density as a function of consolidation stress. In an exemplary embodiment, the present disclosure also provides for systems and methods for improved characterization or definition of a parameter which indicates the flow property of the powder.

Abstract: A process and apparatus for promoting controlled flow of solid material generally comprises a container for holding the solid material and a number of magnetically hard permanent magnet particles within the solid material near the container outlet. The particles are excited with sufficient oscillating electromagnetic energy to create motion and cause sufficient disturbance to break the structure of the solid material and push it out of the outlet.

Abstract: Coater for coating particles is provided with a casing and a cylinder having apertures rotatably mounted within the casing. Gas is blown into the casing and onto the host particles through the slots of the cylinder. Guest particles may be inserted into the casing initially or subsequently after rotation of the cylinder begins. The particles are fluidized when a balance is attained between the centrifugal force from the rotation of the cylinder and the force exerted upon the particles from the air flow. The centrifugal force exerted on the particles within the cylinder in an operating state is at least about 25 gs so as to cause guest particles of different sizes to be coated onto the host.