Abstract: The present invention relates to a pediatric powder for reconstitution as suspension for oral administration comprising a therapeutically effective amount of an antiviral agent or pharmaceutical acceptable salt or derivative thereof, in particular Valaciclovir in complex with an ion exchange resin in a specific ratio in order to obtain a palatable and child-friendly product. It also relates to a process for the preparation thereof.

Abstract: A process may allow the preparation of one or more viscous pharmaceutical formulations and an apparatus may be configured for implementing such a process. A gellable material may be introduced into one chamber, a vehicle may be introduced in the other and by alternately applying force to each chamber, mixing and homogenization may take place. The internal diameter of the connection equipment of the two chambers may be equal to the outlet internal diameters of the chambers. Each chamber may have different diameter, with the first chamber being larger than the second chamber, so as to allow the process to be executed in a simple and more convenient manner.

Abstract: The present invention relates to a preservative free ophthalmic pharmaceutical formulation for topical administration containing a therapeutically effective quantity of Brimonidine or ophthalmological acceptable salts thereof alone or in combination with a therapeutically effective quantity of Timolol or ophthalmological acceptable salts thereof, to be used for the treatment of ocular hypertension and glaucoma.

Abstract: The present invention relates to a method of manufacturing of an immediate release oral liquid formulation comprising ospemifene. Also relates to a self-emulsifying drug delivery system, a self-microemulsifying drug delivery system and a self-nanoemulsifying drug delivery system for oral administration comprising ospemifene and manufacturing methods thereof. Interestingly, the formulations presented in the invention avoid the need for food intake by the patient in need of such treatment previously required for increased bioavailability of Ospemifene tablet formulations.

Abstract: The present invention relates to a stable preservative-free Cyclosporine emulsion in the form of eye drops and a process for the manufacturing thereof, packed in a container that ensures stability of the product for the treatment of keratoconjunctivitis sicca.

Abstract: A process for preparing a powder for reconstitution as a suspension includes the following steps: First, complexing Valaciclovir with an ion exchange resin and forming Drug-Resin complex (DRC) particles. The complexing includes Dry blending of Drug:Ion Exchange Resin in a ratio 1:0.8 to form a blend; Kneading the blend with water in a ratio of Drug:Ion Exchange Resin:Water 1:0.8:0.5 to form a wet mass; Drying of the wet mass at 40° C. Next, milling of the Drug-Resin complex particles until particle size gets less than 250 ?m, and then dry mixing of the Drug-Resin complex particles with excipients to form an internal phase. The excipients of the internal phase comprise a suspending agent and a pH agent, and the suspending agent forms a film around each DRC particle and the film decreases interparticle attraction. Next, mixing the internal phase with excipients of an external phase to form the powder, and then sifting the powder to eliminate any clumps.

Abstract: The present invention relates to a sustained release composition comprising Tapentadol or a pharmaceutically acceptable salt thereof for oral administration for the treatment of severe chronic pain in adults.

Abstract: The present invention relates to a sustained release and abuse proof composition comprising Tapentadol or a pharmaceutically acceptable salt thereof for oral administration for the treatment of severe chronic pain in adults.

Abstract: The present invention relates to a method of manufacturing of a prolonged release solid dispersion formulation comprising Tacrolimus or a pharmaceutically acceptable salt thereof. Furthermore it relates to the manufacturing process of such a dosage form.

Abstract: The present invention relates to water dispersible mini-tablets of Enalapril or a pharmaceutically acceptable salt thereof for use in the treatment of hypertension in a pediatric population. The pediatric population is defined as 0 to 18 years of age. The water dispersible mini-tablets of Enalapril further include a disintegrant, a diluent, a lubricant and a glidant. The active ingredient is distributed evenly in the mini-tablet and the disintegrant comprises Crospovidone. The mini-tablet has a diameter of 3 mm and disintegrates in less than 15 seconds in water.

Abstract: The present invention relates to a preservative-free ophthalmic composition for the reduction of elevated intraocular pressure containing Latanoprost or a combination of Latanoprost and Timolol and to a process for preparing such compositions.

Abstract: The present invention relates to an oral applicable therapeutic dosage form, in particular an orodispersible film comprising Enalapril or pharmaceutically acceptable salts thereof for use in the treatment of hypertension in a pediatric population. The pediatric population is defined from 1 to 18 years of age. The present invention also provides a method of manufacturing of such a dosage form.

Abstract: The present invention relates to a method of manufacturing of an immediate release oral liquid formulation comprising ospemifene. Also relates to a self-emulsifying drug delivery system, a self-mircoemulsifying drug delivery system and a self-nanoemulsifying drug delivery system for oral administration comprising ospemifene and manufacturing methods thereof. Interestingly, the formulations presented in the invention avoid the need for food intake by the patient in need of such treatment previously required for increased bioavailability of Ospemifene tablet formulations.

Abstract: The present invention relates to an ophthalmic aqueous composition for the decrease of intraocular pressure in patients with ocular hypertension or open angle glaucoma containing a combination of Brinzolamide and Brimonidine and a method for preparation thereof. The invention as currently presented has a significant advantage over ophthalmic compositions already known in the art. More particularly the present invention relates to a multi-dose ophthalmic aqueous composition comprising a borate, a single polyol and benzalkonium chloride as an antimicrobial agent.

Abstract: The present invention relates to controlled release pharmaceutical formulations comprising an atypical antipsychotic agent such as Paliperidone or pharmaceutical acceptable salt thereof in the form of a multi-layer tablet that provides zero order drug release. It also relates to a process for the preparation thereof.

Abstract: The present invention relates to a delayed release pharmaceutical composition comprising a fumaric acid ester such as Dimethyl fumarate in the form of gastro-resistant tablets filled into hard gelation capsule.

Abstract: The present invention relates to an oral applicable therapeutic dosage form, in particular an orodispersible film comprising Enalapril or pharmaceutically acceptable salts thereof for use in the treatment of hypertension in a pediatric population. The pediatric population is defined from 1 to 18 years of age. The present invention also provides a method of manufacturing of such a dosage form.

Abstract: The present invention relates to a delayed release pharmaceutical composition comprising a fumaric acid ester such as Dimethyl fumarate in the form of gastro-resistant tablets filled into hard gelation capsule.

Abstract: The present invention relates to the field of drug delivery and, particularly, to alternative processes for preparing ophthalmic compositions of Brinzolamide or pharmaceutical acceptable salts thereof.

Abstract: The present invention relates to a stable pharmaceutical formulation of solid dosage forms for oral administration comprising a therapeutically effective amount of a non-purine selective inhibitor of xanthine oxidase, in particular Febuxostat and an effective amount of an alkalizing agent. It also relates to a process for the preparation thereof.