Abstract: Provided herein are the safety features for radiopharmaceutical infusion system for treatment or diagnostic purpose, wherein infusion system comprises a controller, a source of radiopharmaceutical including other components. The controller is configured to perform automated quality control steps at the start of the system during daily quality control and ensure that system complies to desired technical attributes prior to administration to patients. The quality control steps comprise calibration, breakthrough testing, checking for unauthorized connection and/or malware in the system, network or other connected devices.

Abstract: The present invention relates to a pharmaceutical cold kit composition comprising a chelating agent linked to somatostatin receptor binding organic moiety, a stabilizer, a buffer, and a caking agent or bulking agent, wherein the composition is free of sequestering agent. Further, the present invention also relates to the process of preparing reconstituted or radiolabeled solution composition having high in use stability and radiochemical purity and use thereof for diagnostic and/or therapeutic purposes.

Abstract: Provided herein are the long-acting injection compositions of ?3 adrenoreceptor agonists like mirabegron or their pharmaceutically acceptable salts or esters thereof. The present invention also relates to methods for preparing long-acting injection compositions and methods of using these dosage forms for the treatment of obesity, metabolic diseases, and other diseases as described herein. The long-acting injection compositions as per the present invention have desirable pharmaceutical technical attributes.

Abstract: The present invention relates to a process for the preparation of angiotensin receptor blockers or its pharmaceutically acceptable salts thereof containing less than 10 ppm of the azido impurities.

Abstract: Provided herein are the long-acting injection compositions of ?3 adrenoreceptor agonists like mirabegron or their pharmaceutically acceptable salts or esters thereof. The present invention also relates to methods for preparing long-acting injection compositions and methods of using the prepared dosage forms for the removal of undesirable body fat for the treatment of obesity, metabolic diseases, and other diseases as described herein. The long-acting injection compositions as per the present invention have desirable pharmaceutical technical and clinical attributes.

Abstract: Disclosed are the injection compositions of ?3 adrenoreceptor agonists such as mirabegron or their pharmaceutically acceptable salts or solvates or esters thereof. The present invention also relates to methods for preparing injection compositions and methods of using these dosage forms for the treatment of obesity, other related metabolic diseases, and reduction/removal of fat. The injection compositions as per the present invention have advantages of simple preparation, simple and convenient application, easy absorption, and better effect of treating. The compositions can also be used in cases where oral administration of the drug is not possible due to underlying conditions or concerns around inadequate oral absorption. The injection compositions as per the present invention have desirable pharmaceutical technical attributes.

Abstract: The present invention relates to solid oral pharmaceutical compositions comprising dexamethasone or its pharmaceutically acceptable salts or solvates thereof. The present invention also relates to a process for preparing solid oral pharmaceutical compositions comprising dexamethasone or its pharmaceutically acceptable salts or solvates thereof. The preferred drug load in the compositions of the present invention is from about 0.01% to 15% by weight based on the total weight of the composition. The prepared compositions of dexamethasone as per the present invention exhibit desirable technical attributes.

Abstract: The present invention discloses an extended release oral liquid pharmaceutical composition comprising eslicarbazepine or its pharmaceutically acceptable esters, salts, solvates, polymorphs, enantiomers or mixtures thereof in a pharmaceutically acceptable carrier. The extended release liquid compositions are in the form of ready-to-use liquid compositions or reconstituted liquid compositions. It also relates to processes for the preparation of said extended release liquid compositions. The prior art discloses immediate release oral liquid dosage form. The prepared novel test formulations exhibited desired pharmaceutical technical attributes.

Abstract: The present invention relates to oral ready to use liquid pharmaceutical compositions of eslicarbazepine. It also relates to the processes for the preparation of said liquid compositions. The present invention provides liquid compositions of eslicarbazepine with desired technical attributes such as release profile, viscosity, pH, stability, and acceptable organoleptic properties. The prepared compositions are useful in patients having difficulties in swallowing tablets and provide the physician with providing a more convenient and less cumbersome posology. The suspension compositions as per present invention are useful for the treatment of seizures, partial-onset seizures, epilepsy, neuropathic pain, migraine, fibromyalgia, trigeminal neuralgia, bipolar disorders, attention disorders, anxiety disorders, affective disorders, schizoaffective disorders, sensorimotor disorders, and vestibular disorders.

Abstract: Provided herein are the extended release pharmaceutical composition suitable for once or twice daily dosing comprising riociguat and at least one or more pharmaceutically acceptable excipients. The present invention also relates to method for preparing extended release composition and method of using these dosage forms for the treatment of pulmonary hypertension and related diseases. The present invention provides extended release composition of riociguat which are expected to exhibit desired technical attributes such as assay, stability and release profile suitable for once or twice daily administration.

Abstract: The present invention discloses an extended release oral liquid pharmaceutical composition comprising eslicarbazepine or its pharmaceutically acceptable esters, salts, solvates, polymorphs, enantiomers or mixtures thereof in a pharmaceutically acceptable carrier. The extended release liquid compositions are in the form of ready-to-use liquid compositions or reconstituted liquid compositions. It also relates to processes for the preparation of said extended release liquid compositions. The prior art discloses immediate release oral liquid dosage form. The prepared novel test formulations exhibited desired pharmaceutical technical attributes.

Abstract: The present invention relates to a process for the preparation of angiotensin receptor blockers or its pharmaceutically acceptable salts thereof containing less than 10 ppm of the azido impurities.

Abstract: The present invention relates to oral ready to use liquid pharmaceutical compositions of eslicarbazepine. It also relates to the processes for the preparation of said liquid compositions. The present invention provides liquid compositions of eslicarbazepine with desired technical attributes such as release profile, viscosity, pH, stability, and acceptable organoleptic properties. The prepared compositions are useful in patients having difficulties in swallowing tablets and provide the physician with providing a more convenient and less cumbersome posology.

Abstract: Disclosed are the injection compositions of ?3 adrenoreceptor agonists such as mirabegron or their pharmaceutically acceptable salts or solvates or esters thereof. The present invention also relates to methods for preparing injection compositions and methods of using these dosage forms for the treatment of obesity, other related metabolic diseases, and reduction/removal of fat. The injection compositions as per the present invention have advantages of simple preparation, simple and convenient application, easy absorption, and better effect of treating. The compositions can also be used in cases where oral administration of the drug is not possible due to underlying conditions or concerns around inadequate oral absorption. The injection compositions as per the present invention have desirable pharmaceutical technical attributes.

Abstract: The present invention relates to methods and compositions of vibegron or its pharmaceutically acceptable salts, esters, solvates, polymorphs, enantiomers, or mixtures thereof for reducing body fat. The present invention further provides a method of treating localized fat, double chin disorder, benign symmetric lipomatosis, adiposis dolorosa, lipedema, and familial partial lipodystrophy in a subject by administration of the parenteral pharmaceutical compositions of vibegron. It also relates to a process for the preparation of such compositions.

Abstract: Provided herein are compositions and methods useful in the non-surgical removal of fat deposits in patients in need thereof using ?3-adrenoreceptor agonists. The invention further provides a method of treating double chin disorder, benign symmetric lipomatosis, adiposis dolorosa, lipedema, and familial partial lipodystrophy in patients in need thereof by administration of solabegron or its pharmaceutically acceptable salts, esters, solvates, polymorphs, enantiomers, or mixtures thereof. The treatment method as per the present invention comprises treatment with solabegron or its pharmaceutically acceptable salts, esters, solvates, polymorphs, enantiomers, or mixtures thereof suitable for injection administration. The compositions and treatment method as per the present invention have advantages of simple preparation, simple and convenient application, easy absorption, and better effect of treating without requiring any surgical procedure.

Abstract: The present invention relates to a stable pharmaceutical composition comprising a combination of chlordiazepoxide hydrochloride and clidinium bromide and one or more pharmaceutically acceptable excipients, wherein the composition is in the form of solid oral dosage forms like capsule and sachet. The technical challenges like undesirable impurities in dosage form were successfully controlled by using: a) low moisture excipients; and b) formulation development under controlled temperature and controlled humidity conditions. The formulations as per the present invention are stable and exhibit desired pharmaceutical technical attributes like assay and dissolution. The prepared formulations are useful for the treatment of gastrointestinal disorders and various other therapeutic indications as described herein.

Abstract: Provided herein are the long-acting injection compositions of ?3 adrenoreceptor agonists like mirabegron or their pharmaceutically acceptable salts or esters thereof. The present invention also relates to methods for preparing long-acting injection compositions and methods of using these dosage forms for the treatment of obesity, metabolic diseases, and other diseases as described herein. The long-acting injection compositions as per the present invention have desirable pharmaceutical technical attributes.

Abstract: The present invention relates to the transmucosal dosage forms like sublingual pharmaceutical compositions comprising antiviral molecules like favipiravir, remdesivir, baloxavir marboxil, molnupiravir, besifovir, raltegravir, GS-441524, ravidasvir, and other antiviral drugs. The present invention also relates to methods for preparing these transmucosal pharmaceutical compositions. Compositions prepared as per the present invention are able to increase bioavailability by avoiding first-pass metabolism. The compositions prepared as per the present invention exhibit desired pharmaceutical technical attributes such as pH, assay, related substance, disintegration, and dissolution. The compositions prepared as per the present invention are useful in the treatment of viral infections including coronavirus infection (COVID-19).

Abstract: The present invention relates to stable pharmaceutical compositions of sulfur colloid, which advantageously provide a high radiochemical purity to 99mTc-pertechnetate without causing the gel formation. The compositions include pre-lyophilized and lyophilized compositions of sulfur colloid. It also relates to a non-radioactive kit which upon reconstitution with 99mTc-pertechnetate solution gives stabilized 99mmTc-Sulfur colloid radiopharmaceutical composition. Further, the process for preparation of said compositions and their use for diagnostic purposes are also disclosed.