Abstract: The present invention relates to a modified-release, once-daily, oral pharmaceutical composition comprising isotretinoin and a process for its preparation. In some embodiments, the disclosure is directed to a modified-release, oral pharmaceutical composition comprising isotretinoin or a pharmaceutically acceptable salt, ester or a derivative thereof; and a release modifying agent, wherein the composition is suitable for once daily administration. In some embodiments, the disclosure is directed to a modified-release, oral pharmaceutical composition comprising isotretinoin, wherein the composition comprises an immediate-release component; and a modified-release component comprising a release modifying agent, and wherein the composition is suitable for once daily administration.

Abstract: The present invention relates to extended release liquid compositions of metformin. The extended release liquid compositions are in the form of suspensions or reconstituted powder for suspensions. Said extended release liquid compositions comprise cores of metformin coated with a release-controlling agent, wherein the coated cores are dispersed in a suspension base. Said extended release liquid compositions provide the desired uniform extended release profile throughout the shelf-life of the composition. Furthermore, said extended release liquid compositions are bioequivalent to a reference composition. It also relates to processes for the preparation of said extended release liquid compositions.

Abstract: The present invention relates to a gastroretentive extended release suspension composition, wherein the composition is characterized by having no substantial change in the in-vitro dissolution release profile upon storage for at least seven days. The invention also relates to processes for the preparation of said gastroretentive extended release suspension compositions.

Abstract: The present invention relates to an osmotic floating tablet comprising: (i) an inner core comprising a drug, one or more low density polymers, and one or more pharmaceutically acceptable excipients; and (ii) an outer osmotic coating surrounding the inner core that is substantially permeable to surrounding fluids and substantially impermeable to the drug. The present invention also relates to processes for the preparation of said tablets.

Abstract: This disclosure provides an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units, wherein said capsule dosage form is bioequivalent to the marketed Toprol-XL® tablet. The extended-release capsule dosage form comprising coated discrete units can be sprinkled onto food to ease administration to patients who have difficulty swallowing tablets or capsules.

Abstract: The present invention provides an oral pharmaceutical composition of isotretinoin with a reduced dose. The present invention further relates to a process for preparing the oral pharmaceutical composition of the present invention.

Abstract: The present invention relates to extended release liquid compositions of metformin. The extended release liquid compositions are in the form of suspensions or reconstituted powder for suspensions. Said extended release liquid compositions comprise cores of metformin coated with a release-controlling agent, wherein the coated cores are dispersed in a suspension base. Said extended release liquid compositions provide the desired uniform extended release profile throughout the shelf-life of the composition. Furthermore, said extended release liquid compositions are bioequivalent to a reference composition. It also relates to processes for the preparation of said extended release liquid compositions.

Abstract: The present invention provides an oral pharmaceutical composition of isotretinoin with reduced food effect. The present invention further relates to a process for preparing the oral pharmaceutical composition of the present invention.

Abstract: The present invention relates to controlled-release pharmaceutical dosage forms comprising a solid dispersion of a poorly water-soluble or insoluble drug with improved solubility and thus improved dissolution in an aqueous medium. The invention further discloses a process of preparation of these controlled-release dosage forms.

Abstract: This disclosure provides an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units, wherein said capsule dosage form is bioequivalent to the marketed Toprol-XL® tablet. The extended-release capsule dosage form comprising coated discrete units can be sprinkled onto food to ease administration to patients who have difficulty swallowing tablets or capsules.

Abstract: An oral pharmaceutical composition of isotretinoin with reduced food effect. A process for preparing the oral pharmaceutical composition of the present invention.

Abstract: This disclosure provides an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units, wherein said capsule dosage form is bioequivalent to the marketed Toprol-XL® tablet. The extended-release capsule dosage form comprising coated discrete units can be sprinkled onto food to ease administration to patients who have difficulty swallowing tablets or capsules.

Abstract: The present invention relates to a pharmaceutical gastro-retentive solid oral dosage form comprising nilotinib as the active ingredient. The invention is further related to methods of preparing said dosage form.

Abstract: The present invention relates to a multilayered coated tablet comprising at least three layers, i.e., first, second and third layer wherein the first and third layers contain at least one active pharmaceutical ingredient and the second layer is either a placebo or an immediate-release drug layer. Further, the tablet has a delayed-release coating, wherein the coating may contain one or more pore-forming agents and/or orifices on one or both sides. Furthermore, it may contain an immediate-release layer of the drug over the delayed-release coating layer. The present invention further relates to processes for preparing such a multilayered coated tablet.

Abstract: The present invention relates to sustained release oral pharmaceutical compositions of tofacitinib comprising tofacitinib, a release controlling polymer, and pharmaceutically acceptable excipients, wherein the sustained release oral pharmaceutical compositions further comprise an outer modified release coating that includes a modified release polymer. The invention also relates to a process for the preparation of the compositions.

Abstract: This disclosure provides an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units, wherein said capsule dosage form is bioequivalent to the marketed ToprolXL® tablet. The extended-release capsule dosage form comprising coated discrete units can be sprinkled onto food to ease administration to patients who have difficulty swallowing tablets or capsules.

Abstract: The present invention relates to a once daily pharmaceutical composition comprising doxycycline and one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition exhibits a reduced food effect. The invention further provides a method of treatment of rosacea by administering to a person in need thereof the doxycycline pharmaceutical composition with or without food. A process of preparing such pharmaceutical composition is also provided.

Abstract: The present invention relates to a once daily pharmaceutical composition comprising doxycycline, a controlled-release polymer, and one or more pharmaceutically acceptable excipients. The invention further provides a method of treatment of rosacea by administering such pharmaceutical composition. A process of preparing such pharmaceutical composition is also provided.

Abstract: The present invention relates to extended release liquid compositions of guanfacine. The extended release liquid compositions of the present invention are bioequivalent to marketed extended release tablet compositions of guanfacine. Said extended release liquid compositions provide substantially similar in-vitro dissolution release profile upon storage for at least seven days. Further, the extended release liquid compositions are stable. 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.

Abstract: The present invention relates to oral liquid compositions of guanfacine. The liquid. compositions can be immediate release or extended release compositions. The compositions comprise guanfacine in a concentration from about 0.1 mg/mL to about 12.0 mg/mL of the composition. The liquid compositions can be in the form of ready-to use liquid compositions or reconstituted liquid compositions. It further relates to processes for the preparation of said oral liquid compositions.