Abstract: A method includes obtaining first data indicative of a measured profile of a substrate. The method further includes obtaining second data indicative of a profile of a reference substrate. The method further includes determining a corrected substrate profile based on the first data and the second data. The method further includes performing a corrective action based on the corrected substrate profile.

Abstract: A co-rotating twin screw processor for preparing dry granules including an input zone having one or more powder feeders for feeding an input material into the processor, a steam feeder configured to introduce steam as a granulation activating agent in to the processor, a granulation zone for granulating the input material in the presence of steam to form granules, a controller configured to control operation and feed rate of at least one of the powder feeder or the steam feeder such that 2.5 to 5 percent w/w of the steam with respect to the input material is available for granulation, and a discharge zone haring a non-extruding opening for collecting dry granules.

Abstract: The present disclosure concerns effervescent compositions and methods of making and using the same. In some embodiments, the disclosed effervescent compositions are formed from an input blend comprising an acid and a base by granulating the input blend in a twin-screw processor. The granules formed from the input blend can be formed by an in situ granulating agent, which can be a portion of the acid that melts during granulation. In some embodiments, the effervescent compositions can be made using a twin-screw processor comprising an intake zone for receiving an input blend comprising an acid and a base; a granulation initiation zone for melting only a portion of the acid to serve as an in situ granulating agent; a granulation completion zone for granulating the input blend; and an outlet for discharging the granules.

Abstract: The present disclosure concerns effervescent compositions and methods of making and using the same. In some embodiments, the disclosed effervescent compositions are formed from an input blend comprising an acid and a base by granulating the input blend in a twin-screw processor. The granules formed from the input blend can be formed by an in situ granulating agent, which can be a portion of the acid that melts during granulation. In some embodiments, the effervescent compositions can be made using a twin-screw processor comprising an intake zone for receiving an input blend comprising an acid and a base; a granulation initiation zone for melting only a portion of the acid to serve as an in situ granulating agent; a granulation completion zone for granulating the input blend; and an outlet for discharging the granules.

Abstract: The present disclosure relates to a process for preparing granules from an input material or a powder material. The process comprises feeding the input material for granulation in the processor using one or more powder feeders, introducing steam as a granulation activating agent in the processor, granulating the input material in presence of the steam to form granules, and optionally collecting the granules from a discharge zone of the processor, wherein feed rate of the steam into the processor is determined based on feed rate of the input material into the processor. A co-rotating twin-screw processor for preparing granules is also disclosed.

Abstract: A process for preparing granules is disclosed. The process comprises the steps of feeding the input material for granulation in a processor using one or more powder feeders, introducing steam as a granulation activating agent in the processor, granulating the input material in presence of the steam to form granules, and collecting the granules from a discharge zone of the processor. A co-rotating twin-screw processor for preparing granules is also disclosed.

Abstract: A rapidly disintegrating tablet comprising a therapeutically effective amount of a DPP-IV inhibitor and an acid-base couple having mineral content below the daily intake limits is disclosed. The rapidly disintegrating tablet has a sodium content less than 10 mg and a potassium content less than 15 mg. A process for preparation of the rapidly disintegrating tablet comprising the DPP-IV inhibitor is also disclosed.

Abstract: A co-rotating twin screw extruder for forming fragments is disclosed. The extruder comprises of an intake zone for receiving one or more excipient(s) suitable for oral dosage or one or more excipient(s) suitable for oral dosage along with one or more active pharmaceutical ingredient, a melt zone for softening at least one excipient to form a viscous mass or melt and a fragmenting zone for fragmenting and cooling the viscous mass into cooled fragments and an extruder outlet for recovering the cooled fragments from the extruder.

Abstract: A stable pharmaceutical composition consisting of (a) benazepril, in free or pharmaceutically acceptable salt form; and (b) amlodipine, in free or pharmaceutically acceptable salt form. The composition is free of alkali and alkaline earth metal carbonates and phosphates. The composition is also free of excipients which increase the pH of microenvironment above 5. It is therefore not required to physically separate the two drugs from each other.

Abstract: The present disclosure relates to a process for preparing granules from an input material or a powder material. The process comprises feeding the input material for granulation in the processor using one or more powder feeders, introducing steam as a granulation activating agent in the processor, granulating the input material in presence of the steam to form granules, and optionally collecting the granules from a discharge zone of the processor, wherein feed rate of the steam into the processor is determined based on feed rate of the input material into the processor.

Abstract: A co-rotating twin screw extruder for forming fragments is disclosed. The extruder comprises of an intake zone for receiving one or more excipient(s) suitable for oral dosage or one or more excipient(s) suitable for oral dosage along with one or more active pharmaceutical ingredient, a melt zone for softening at least one excipient to form a viscous mass or melt and a fragmenting zone for fragmenting and cooling the viscous mass into cooled fragments and an extruder outlet for recovering the cooled fragments from the extruder.

Abstract: A co-rotating twin screw extruder for forming fragments is disclosed. The extruder comprises of an intake zone for receiving one or more excipient(s) suitable for oral dosage or one or more excipient(s) suitable for oral dosage along with one or more active pharmaceutical ingredient, a melt zone for softening at least one excipient to form a viscous mass or melt and a fragmenting zone for fragmenting and cooling the viscous mass into cooled fragments and an extruder outlet for recovering the cooled fragments from the extruder.

Abstract: The present disclosure concerns effervescent compositions and methods of making and using the same. In some embodiments, the disclosed effervescent compositions are formed from an input blend comprising an acid and a base by granulating the input blend in a twin-screw processor. The granules formed from the input blend can be formed by an in situ granulating agent, which can be a portion of the acid that melts during granulation. In some embodiments, the effervescent compositions can be made using a twin-screw processor comprising an intake zone for receiving an input blend comprising an acid and a base; a granulation initiation zone for melting only a portion of the acid to serve as an in situ granulating agent; a granulation completion zone for granulating the input blend; and an outlet for discharging the granules.

Abstract: A co-rotating twin screw extruder for forming fragments is disclosed. The extruder comprises of an intake zone for receiving one or more excipient(s) suitable for oral dosage or one or more excipient(s) suitable for oral dosage along with one or more active pharmaceutical ingredient, a melt zone for softening at least one excipient to form a viscous mass or melt and a fragmenting zone for fragmenting and cooling the viscous mass into cooled fragments and an extruder outlet for recovering the cooled fragments from the extruder.

Abstract: A pharmaceutical suspension formulation comprising a dose greater than 100 mg/5 ml Cefixime and pharmaceutically acceptable excipients.

Abstract: A chewable tablet comprising Cefixime having a mean particle size between 20? and 120? wherein the said composition demonstrates bioequivalence to a suspension of Cefixime trihydrate. The process of preparation of the chewable tablet comprises the steps of optionally micronizing Cefixime such that the mean particle size of the Cefixime particles is between 20? and 120?, blending with other excipients, roll compaction, milling to form granules, blending to form a secondary blend and compression of the secondary blend to form tablets.

Abstract: A stable taste masked, pharmaceutical composition comprising a plurality of coated, non-disintegrating discrete dosage units, said units comprising of a core comprising one or more cephalosporins such as cefuroxime axetil and cefpodoxime proxetil and one or more coating layers. Cefuroxime axetil is in ?-crystalline and amorphous forms, where at least 30% of the Cefuroxime axetil is in the ?-crystalline form, wherein the particle size distribution of the ?-crystalline form being such that 100% of the particles have a particle size below 250?. The ratio of the crystalline fraction to the amorphous fraction ranges from 0.3:0.7 to 0.99:0.01. The particle size of cefpodoxime proxetil is such that 90% of the particles are below 15?.

Abstract: A chewable tablet comprising Cefixime having a mean particle size between 20? and 120? wherein the said composition demonstrates bioequivalence to a suspension of Cefixime trihydrate. The process of preparation of the chewable tablet comprises the steps of optionally micronizing Cefixime such that the mean particle size of the Cefixime particles is between 20? and 120?, blending with other excipients, roll compaction, milling to form granules, blending to form a secondary blend and compression of the secondary blend to form tablets.

Abstract: An improved stable pharmaceutical composition for controlled release of an active ingredient comprises a betalactam antibiotic such as cephalexin, cefaclor or their pharmaceutically acceptable hydrates, salts or esters as active ingredient, a calcium salt and a mixture of hydrophilic polymers selected from the group consisting of at least one sodium alginate and one xanthan gum and with or without hydroxypropyl methylcellulose, said composition optionally containing probenecid. The composition may also contain one or more of a water soluble and/or water dispersible diluent, wherein the quantities of the hydrophilic polymers and water soluble and/or water dispersible diluents are such that the therapeutically effective active ingredient is released at a rate suitable for once or twice daily administration of the pharmaceutical composition.

Abstract: A controlled release dosage forms comprising zolpidem or a salt thereof to release zolpidem to induce rapid onset of sleep, and continue to release zolpidem in a controlled manner to maintain effective plasma concentrations over an extended period of time to improve sleep maintenance. The pharmaceutical controlled-release dosage form of zolpidem or a salt thereof having a dissolution profile when measured in a type I or II dissolution apparatus according to the U.S. Pharmacopoeia in 0.01M hydrochloric acid buffer at 37° C., such that less than 40% is released at the end of 30 minutes.