Elepsia™ XR is a novel, once-a-day formulation of Levetiracetam, a commercially successful anti-epileptic agent.The average daily dose of Levetiracetam in majority of patients is in the range of 2000 mg to 3000 mg per day. However, only 500 mg and 750 mg strength once-a-day tablet formulations are available in the market today, which makes it necessary for patients to take multiple pills in a day.
Elepsia™ XR is designed as higher strengths of 1000 mg and 1500 mg once-a-day tablet for reducing pill burden. Although the dose per tablet is high, the proprietary Wrap Matrix™ Technology helps Elepsia™ XR tablets to be formulated with less excipients, thereby making the tablet compact and better acceptable for patients.
Elepsia™ XR represents a new therapeutic option to reduce pill burden and improve patient compliance. Elepsia™ XR is protected by composition and dose specific patents granted in US.
SPARC has filed New Drug Application (NDA) with USFDA for Elepsia™ XR and has licensed Elepsia™ XR for US market to a subsidiary of Sun Pharmaceutical Industries Limited.Elepsia™ XR is licensed for US market to a subsidiary of Sun Pharmaceutical Industries Limited.
However, it needs to be administered at very high doses. More than 80% of epilepsy patients require Levetiracetam dose in the range of 1000 mg to 3000 mg. Currently Levetiracetam extended release tablets are available in market in only two strengths – 500 Mg and 750 mg. So patients who require high doses need to take multiple tablets resulting in significant pill burden.
ELEPSIA™ XR Tab with higher strengths of Levetiracetam 1000 mg and 1500 mg are developed using SPARC’s proprietary Wrap Matrix™ Technology. It offer a novel once a day formulation of Levetiracetam. ELEPSIA XR represents a new therapeutic option to reduce pill burden and improve patient compliance. ELEPSIA XR is protected by composition and dose specific patents granted in US.
High Drug/Excipients ratio makes it possible to formulate a larger Levetiracetam dose (up to 1500 mg) in relatively smaller and compact tablet.ELEPSIA™ XR is a bilayer tablet: the first layer is the drug containing layer in an extended release form and the second layer is a highly swellable (openable) layer which expands in volume to a very large extent on contact with aqueous medium. The bilayer tablet is coated with a water insoluble functional coat and a top coat. A laser-drilled orifice is present on the openable layer side. When ELEPSIA XR Tablet comes in contact with an aqueous medium, water ingresses through the orifice causing the openable layer to expand and remove the coating on that side. This leads to defined surface area exposure from which drug is released in a controlled manner. Thus release of the active ingredient occurs from one surface only. This unique system offers the advantage of a zero order release or delivery of a constant amount of drug with respect to the time. A constant drug delivery rate from the dosage form ensures that the plasma drug concentration remains constant within the effective levels. Side effects of the drug are thus reduced as the patient is not unnecessarily exposed to peaks & troughs of drug levels in the plasma. No residual drug remains in the dosage form on evacuation.