Abstract: A complexation process between a cyclodextrin and active pharmaceutical ingredients is disclosed, and comprises a process for preparing a complex of at least one cyclodextrin and at least one active pharmaceutical ingredient comprising the steps of a. Preparing a first solution (solution A) comprising at least one cyclodextrin and at least one solvent; b. Preparing a second solution (solution B) comprising at least one dissolved, partially dissolved or suspended API; c. Mixing said solution A and solution B by means of a microfludization system to produce a solution and/or suspension of at least one of said complex; d. Isolating said solution and/or suspension and/or optionally drying it; and e. Optionally collecting a powdered form of the complex. The described process has high throughput with higher yields of complexation in less time than prior art methods.

Abstract: The present invention discloses a spray drying process characterized by continuous preparation and immediate spray drying of a solution comprising at least one active pharmaceutical ingredient and/or at least one excipient, and at least one solvent. The said active pharmaceutical ingredient(s) and solvent(s) are combined, alone or along with one or more excipients to form a first suspension. Said suspension is continuously fed to an intensifier pump that pushes said suspension through at least one micro-reaction chamber and/or at least one micro-channel where the suspension's solid(s) component(s) is(are) dissolved into said solvent(s) by means of high energy mixing I forced contact at micro, nano and molecular level to form a solution stream. The said solution stream is then immediately and continuously fed to the spray dryer through at least one atomization nozzle, drying said atomized stream to obtain solid particles and collecting said solid particles.

Abstract: The present invention discloses a spray drying process characterized by continuous preparation and immediate spray drying of a solution comprising at least one active pharmaceutical ingredient and/or at least one excipient, and at least one solvent. The said active pharmaceutical ingredient(s) and solvent(s) are combined, alone or along with one or more excipients to form a first suspension. Said suspension is continuously fed to an intensifier pump that pushes said suspension through at least one micro-reaction chamber and/or at least one micro-channel where the suspension's solid(s) component(s) is(are) dissolved into said solvent(s) by means of high energy mixing I forced contact at micro, nano and molecular level to form a solution stream. The said solution stream is then immediately and continuously fed to the spray dryer through at least one atomization nozzle, drying said atomized stream to obtain solid particles and collecting said solid particles.

Abstract: An improved spray drying method for production of amorphous solid dispersions with enhanced bulk density and material attributes comprising the introduction of at least one additional stream in at least one of multiple locations in a spray dryer without interfering with the spray region.

Abstract: The present invention discloses a method to continuously manufacture micro- and/or nanoparticles of single component particles or multi-component particles such as particulate amorphous solid dispersions or particulate co-crystals. The continuous method comprises the steps of 1. preparing a first solution comprising at least one component and at least one solvent and a second solution comprising at least one anti-solvent of the at least one component comprised in the first solution, 2. mixing said first solution and said second solution by means of microfluidization to produce a suspension by precipitation or co-precipitation, 3. feeding said suspension to a filtration system to obtain a concentrate stream, 4. feeding said concentrate stream to a spray dryer, 5. atomizing said concentrate stream using at least one atomization nozzle, 6. drying said atomized concentrate stream to obtain particles, and 7. collecting said particles.

Abstract: An improved spray drying method for production of amorphous solid dispersions with enhanced bulk density and material attributes comprising the introduction of at least one additional stream in at least one of multiple locations in a spray dryer without interfering with the spray region.

Abstract: An improved spray drying method for production of amorphous solid dispersions with enhanced bulk density and material attributes comprising the introduction of at least one additional stream in at least one of multiple locations in a spray dryer without interfering with the spray region.

Abstract: A new scalable process to control the particle size and the particle size distribution, comprising 5 steps: (i) suspension preparation in a mixture of solvents in which the API and/or excipient is partially soluble in one of the solvents; (ii) particle size reduction of the suspension; (iii) aging; (iv) stopping the aging by solvent removal; and (v) optionally, a step of isolating the processed ingredients in the form of powder.

Abstract: A complexation process between a cyclodextrin and active pharmaceutical ingredients is disclosed, and comprises a process for preparing a complex of at least one cyclodextrin and at least one active pharmaceutical ingredient comprising the steps of a. Preparing a first solution (solution A) comprising at least one cyclodextrin and at least one solvent; b. Preparing a second solution (solution B) comprising at least one dissolved, partially dissolved or suspended API; c. Mixing said solution A and solution B by means of a microfludization system to produce a solution and/or suspension of at least one of said complex; d. Isolating said solution and/or suspension and/or optionally drying it; and e. Optionally collecting a powdered form of the complex. The described process has high throughput with higher yields of complexation in less time than prior art methods.

Abstract: The present invention discloses a method to continuously manufacture micro- and/or nanoparticles of single component particles or multi-component particles such as particulate amorphous solid dispersions or particulate co-crystals. The continuous method comprises the steps of 1. preparing a first solution comprising at least one component and at least one solvent and a second solution comprising at least one anti-solvent of the at least one component comprised in the first solution, 2. mixing said first solution and said second solution by means of microfluidization to produce a suspension by precipitation or co-precipitation, 3. feeding said suspension to a filtration system to obtain a concentrate stream, 4. feeding said concentrate stream to a spray dryer, 5. atomizing said concentrate stream using at least one atomization nozzle, 6. drying said atomized concentrate stream to obtain particles, and 7. collecting said particles.

Abstract: The present invention discloses a method for producing amorphous solid dispersions in a nanoparticulate form, through solvent controlled co-precipitation, using microfluidization/microreaction technology to promote high energy mixing/interaction at a micro and/or molecular level between the streams involved in the process. Feed streams, solvent and anti-solvent, are fed to an intensifier pump at individually controlled rates and forced to interact to micro- and/or nano-scale within a microreactor. The present invention also discloses amorphous solid dispersions obtained by the method of the invention as well as pharmaceutical compositions containing the same.

Abstract: An improved spray drying method for production of amorphous solid dispersions with enhanced bulk density and material attributes comprising the introduction of at least one additional stream in at least one of multiple locations in a spray dryer without interfering with the spray region.

Abstract: A new scalable process to control the particle size and the particle size distribution, comprising5 steps: (i) suspension preparation in a mixture of solvents in which the API and/or excipient is partially soluble in one of the solvents; (ii) particle size reduction of the suspension; (iii) aging; (iv) stopping the aging by solvent removal; and (v) optionally, a step of isolating the processed ingredients in the form of powder.

Abstract: The present invention discloses a scalable and solvent-free method to produce cocrystals in a particulate form. A method of making cocrystals comprises the steps of: a) feeding a molten mixture of at least a first substance and a second substance which are able to form cocrystals to an atomizer; b) atomizing the molten mixture to droplets; c) solidifying the droplets to particles; d) collecting the said particles. The invention also provides the use of cocrystals made according to the method of the invention in the formulation of a pharmaceutical composition. The invention also provides cocrystals obtainable or obtained by the method of the present invention, in particular cocrystals in the form of particles. Also provided is a pharmaceutical composition comprising cocrystals made according to the method of the invention, in particular, a pharmaceutical composition comprising cocrystals in the form of particles made according to the method of the invention.

Abstract: The present invention relates to a novel process for the preparation of tiotropium bromide there is provided a process for preparing tiotropium bromide comprising (i) reacting scopine oxalate with diethylamine in an inert solvent to form scopine; (ii) reacting scopine and methyl di-(2-dithienyl)glycolate (MDTG) in the presence of an inorganic base, and in an inert solvent to form N-demethyltiotropium; (iii) reacting N-demethyltiotropium with bromomethane in an inert solvent to form tiotropium bromide; (iv) crystallizing tiotropium bromide in a mixture of methanol and acetone, and optionally thereafter, (v) micronizing the tiotropium bromide so formed.

Abstract: The disclosure provides oral solid particle formulations comprising of an iodinated imaging agent and at least one taste masking agent showing improved bioadhesive properties, and are also useful for imaging of the gastrointestinal tract.

Abstract: The present invention relates to a novel process for the preparation of tiotropium bromide there is provided a process for preparing tiotropium bromide comprising (i) reacting scopine oxalate with diethylamine in an inert solvent to form scopine; (ii) reacting scopine and methyl di-(2-dithienyl)glycolate (MDTG) in the presence of an inorganic base, and in an inert solvent to form N-demethyltiotropium; (iii) reacting N-demethyltiotropium with bromomethane in an inert solvent to form tiotropium bromide; (iv) crystallizing tiotropium bromide in a mixture of methanol and acetone, and optionally thereafter, (v) micronizing the tiotropium bromide so formed.