Abstract: A method for preparing granules. A slurry containing solid API powder particles dispersed in a liquid is prepared. The slurry is fed to a granulator and mixed with a dry base powder within the granulator in order to produce a slurry/base powder mixture. The slurry/base powder mixture produced within the granulator is dried in order to obtain granules containing the solid API particles and the base powder.

Abstract: A method of preparing a pharmaceutical product comprises the steps of (a) providing a neat active pharmaceutical ingredient (API) complying with at least five of the following parameters determined by using a FT4 powder rheometer: (i) specific basic flow energy of at most 60 mJ/g; (ii) stability index of 0.75 to 1.25; (iii) specific energy of at most 10 mJ/g; (iv) major principle stress at 15 kPa of at most 40; (v) flow function at 15 kPa of at least 1.3; (vi) consolidated bulk density at 15 kPa of at least 0.26 g/mL; (vii) compressibility of at most 47%; and (viii) wall friction angle of at most 40°; (b) dispensing the neat API of step (a) into a bottom part of a pharmaceutical carrier using a vacuum assisted metering and filling device; and (c) encapsulating the bottom part, thereby producing a pharmaceutical product.

Abstract: The invention relates to developing a novel water and capsule formulation using fenofibrate which is difficult to dissolve and control its release rate in vitro. For example, the invention relates to the creation of capsules and wafers comprising: fenofibrate, a surfactant, a carrier wax, a film former, a plasticizer, and optionally a super disintegrant or other ingredients. The invention further relates to the process of forming such capsules and wafers.

Abstract: A formulation for injection moulding of a pharmaceutical carrier comprising 27-85% (w/w) of polyvinyl alcohol, and 10-60% (w/w) of a disintegration aid selected from maize starch, wheat starch, and combinations thereof; and optionally one or more excipients.

Abstract: The present invention relates to methods of preparing pharmaceutical products, involving filling active pharmaceutical ingredient powders into pharmaceutical carriers with a vacuum assisted metering and filling device. The methods disclosed herein can be used in a continuous process, such as in a high-throughput process for producing a pharmaceutical product. The present invention further relates to a particular quality of the neat active pharmaceutical ingredient (API) HDM201, i.e. siremadlin, present as succinic acid co-crystal, which can be used in the methods of preparation of the present invention.

Abstract: A single-dose package for transdermal therapeutic systems or film-shaped administration forms, in the form of a tear-open sealed-edge pouch with a completely surrounding and continuous non-peelable sealing surface. The single-dose packages are provided with two packaging material elements, which are arranged one lying on top of the other and form the upper side and underside of a pouch that contains the product. At least one packaging material element is a tear-resistant film laminate with an at least three-layer structure, wherein at least one layer of the packaging material elements is a metal layer. The single-dose package also has a linear weakening, which lies in the sealing area, does not touch the edge of the package and extends in the direction of the weaker tear resistance of the upper side and underside and the linear form of the anisotropically tear-resistant plastic.

Abstract: The invention relates to a drying device for drying a product comprising: a housing having a drying chamber, a product inlet at a first end and an product outlet at a second end; a drying rotor arranged rotatable within the drying chamber and having at least one helical groove at the outer surface thereof; a screw having a flight with a flight channel there between and arranged rotatable within the drying chamber and substantially parallel to the drying rotor; a driving mechanism configured for driving the screw in rotation around a screw axis; and a heater for providing thermal energy to the drying chamber, wherein the drying rotor and/or the screw at least are configured for moving the product from the first end to the second end, and such that the flight of the screw engages into the at least one helical groove of the drying rotor.

Abstract: A method for preparing granules a slurry containing solid API powder particles dispersed in a liquid is prepared. The slurry is fed to a granulator and mixed with a dry base powder within the granulator in order to produce a slurry/base powder mixture. The slurry/base powder mixture produced within the granulator is dried in order to obtain granules containing the solid API particles and the base powder.

Abstract: The present invention relates to a transmucosal administration system to administer quinones, benzoquinones, and especially 1,4-benzoquinones, via the oromucosal route.

Abstract: A method of preparing a pharmaceutical product comprises the steps of (a) providing a neat active pharmaceutical ingredient (API) complying with at least five of the following parameters determined by using a FT4 powder rheometer: (i) specific basic flow energy of at most 60 mJ/g; (ii) stability index of 0.75 to 1.25; (iii) specific energy of at most 10 mJ/g; (iv) major principle stress at 15 kPa of at most 40; (v) flow function at 15 kPa of at least 1.3; (vi) consolidated bulk density at 15 kPa of at least 0.26 g/mL; (vii) compressibility of at most 47%; and (viii) wall friction angle of at most 40°; (b) dispensing the neat API of step (a) into a bottom part of a pharmaceutical carrier using a vacuum assisted metering and filling device; and (c) encapsulating the bottom part, thereby producing a pharmaceutical product.

Abstract: A formulation for injection molding of a pharmaceutical carrier comprises 43.5-97% (w/w) of one or more polyethylene oxide polymer having a weight average molecular weight of MW 94,000-188,000; and optionally one or more excipients.

Abstract: An edible orally disintegrating tablet dosage form containing an unpalatable acidic active pharmaceutical ingredient, particularly ketoprofen, and an ion exchange resin as a primary taste masking agent, along with an optional alkaline agent and further optionally containing one or more secondary taste masking agents is provided. The edible orally disintegrating tablet dosage matrix is formed from at least one water soluble or miscible polymer(s). The optional secondary taste masking ingredients include one or more of flavoring agent(s), sweetener(s), cooling sensation agent(s), and taste receptor blocker(s). The inventive dosages minimize or completely mask the bitterness, burning sensation and throat irritation associated with many acidic active pharmaceutical ingredients. Methods for preparing the inventive edible oral film strip dosage forms are disclosed, as well as their method of administration.

Abstract: A pharmaceutical carrier (20) comprises a lid part (22) and a bottom part (24), wherein at least one of the lid part (22) and the bottom part (24) has a first wall section (26, 30) with a thickness of 180-250 ?m, preferably 185-225 ?m, even more preferably 190-220 ?m, and most preferably about 215 ?m, and a second wall section (28, 32) with a thickness of 350-450 ?m, preferably 375-425 ?m, more preferably 390-410 ?m, and most preferably about 400 ?m. The first wall section (26) of the lid part (22) defines an entire top portion of the lid part (22). Alternatively or additionally thereto, the first wall section (30) of the bottom part (24) defines an entire bottom portion of the bottom part (24).

Abstract: The present invention relates to a transmucosal administration system to administer quinones, benzoquinones, and especially 1,4-benzoquinones, via the oromucosal route.

Abstract: In a method for preparing at least partially dried granules, an API, a base powder, and a granulation liquid are fed to a granulator. The API, the base powder and the granulation liquid are mixed within the granulator to produce an API/base powder/granulation liquid mixture. This liquid mixture within the granulator is heated to a heating temperature (TH) that exceeds an evaporation temperature (TE) of the granulation liquid contained in an API/base powder/granulation liquid mixture to allow at least a part of the granulation liquid contained in the API/base powder/granulation liquid mixture to evaporate in order to obtain at least partially dried granules containing at least the API and the base powder. The at least partially dried granules are discharged from the granulator.

Abstract: The invention generally relates to transmucosal administration systems for administering quinones, benzoquinones, and especially 1,4-benzoquinones, via the oromucosal route. The present invention more specifically relates to methods of treatment for Duchenne Muscular Dystrophy that includes administering to a patient a dose in the form of one or more transmucosal administration systems.

Abstract: An edible orally disintegrating tablet dosage form containing an unpalatable acidic active pharmaceutical ingredient, particularly ketoprofen, and an ion exchange resin as a primary taste masking agent, along with an optional alkaline agent and further optionally containing one or more secondary taste masking agents is provided. The edible orally disintegrating tablet dosage matrix is formed from at least one water soluble or miscible polymer(s). The optional secondary taste masking ingredients include one or more of flavoring agent(s), sweetener(s), cooling sensation agent(s), and taste receptor blocker(s). The inventive dosages minimize or completely mask the bitterness, burning sensation and throat irritation associated with many acidic active pharmaceutical ingredients. Methods for preparing the inventive edible oral film strip dosage forms are disclosed, as well as their method of administration.

Abstract: An edible oral film strip dosage form containing an unpalatable basic active pharmaceutical ingredient and an ion exchange resin as a primary taste masking agent, along with an optional acidic agent and further optionally containing one or more secondary taste masking agents is provided. The edible oral film strip dosage matrix is formed from at least one water soluble or miscible polymer(s). The optional secondary taste masking ingredients include one or more of flavoring agent(s), sweetener(s), cooling sensation agent(s), and taste receptor blocker(s). Methods for preparing the inventive edible oral film strip dosage forms are disclosed, as well as their method of administration.

Abstract: Materials containing pharmaceutically active species in solid (e.g., crystal) form, and related methods, are provided, allowing for improved stability, solubility, bioavailability, and/or dissolution rates for pharmaceutically active species having poor aqueous solubility.

Abstract: The invention relates to developing a novel water and capsule formulation using fenofibrate which is difficult to dissolve and control its release rate in vitro. For example, the invention relates to the creation of capsules and wafers comprising: fenofibrate, a surfactant, a carrier wax, a film former, a plasticizer, and optionally a super disintegrant or other ingredients. The invention further relates to the process of forming such capsules and wafers.