IntelliPharmaCeutics
Encyclopedia
IntelliPharmaCeutics is a Canadian specialty pharmaceutical
company, operating internationally and primarily engaged in the research, development, and commercialization of controlled-release and targeted pharmaceutical products.
(5, 10, 15, 20 mg strengths) and is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration
(FDA).
Focalin XR is an extended-release formulation of dexmethylphenidate and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood.
In December 2010, IntelliPharmaCeutics filed an ANDA with the U.S. FDA for approval to market a generic of the 30 mg strength of Focalin XR.
Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride. It is indicated for the treatment of symptoms of major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder.
Protonix is a delayed-release capsule for oral administration that contains pantoprazole sodium. Protonix inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.
The pilot clinical trial produced the following results:
Pharmacology
Pharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function...
company, operating internationally and primarily engaged in the research, development, and commercialization of controlled-release and targeted pharmaceutical products.
Focalin XR
Dexmethylphenidate XR is a generic version of the marketed drug Focalin XR, which is partnered with Par PharmaceuticalPar Pharmaceutical
Par Pharmaceutical develops, manufactures and markets generic and branded specialty pharmaceuticals. Par was founded in 1978 and initially traded on the New York Stock Exchange in 1987...
(5, 10, 15, 20 mg strengths) and is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA).
Focalin XR is an extended-release formulation of dexmethylphenidate and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood.
In December 2010, IntelliPharmaCeutics filed an ANDA with the U.S. FDA for approval to market a generic of the 30 mg strength of Focalin XR.
Venladaxine XR/Effexor XR
Venlafaxine XR is a generic version of the marketed drug Effexor XR. This product is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the U.S. FDA.Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride. It is indicated for the treatment of symptoms of major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder.
Pantoprozole XR/Protonix XR
IntelliPharmaCeutics' Pantoprozole XR is a delayed release pantoprazole sodium, a generic version of the marketed drug Protonix. This product is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the U.S. FDA.Protonix is a delayed-release capsule for oral administration that contains pantoprazole sodium. Protonix inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.
Rexista
Rexista is one of IntelliPharmaCeutics non-generic development products. It is an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation. This product is covered by pending patent applications. Rexista is a unique dosage form, designed to be resistant to well-documented abuse that is experienced with current oxycodone products. This includes abuse by injection when combined with solvents and by nasal inhalation when crushed or powdered. Rexista is also designed to resist release of the entire dose when consumed with alcohol, a significant problem with some opioid drugs, such as hydromorphone.The pilot clinical trial produced the following results:
- The Rexista product demonstrated sustained release pharmacokinetic activity, with blood plasma concentrations at clinically significant levels over a 24 hour period.
- The bioavailability of a single dose of the Rexista product, as measured by Cmax and AUC, was comparable to that of two doses of Oxycontin® dosed at 12 hour intervals. Both Cmax and AUC were in the 80% - 125% range as compared to Oxycontin, demonstrating effective bioequivalence with the branded product.