The study protocol and informed consent form were approved by the Covance Clinical Research Unit Institutional Review Board (Madison, WI, USA). This phase I, open-label, randomized, single-dose, three-way crossover study in healthy adults (aged 18–55 years) was conducted from 27 December, 2004, to 26 January, 2005. Secondary study objectives included assessment of the bioavailability of 50 mg of SHP465 MAS after sprinkling the contents of an SHP465 MAS capsule over applesauce relative to the fasted state and the assessment of the safety and tolerability of 50 mg of SHP465 MAS. The primary objective of the study was to assess the effect of a high-fat meal on the bioavailability of 50 mg of SHP465 MAS relative to the fasted state. This study evaluated the pharmacokinetics of d- and l-amphetamine when SHP465 MAS was administered after a high-fat meal or after the capsule contents were sprinkled on applesauce relative to consumption of an intact SHP465 MAS capsule in fasting healthy adults. Helping to address the issues associated with swallowing capsules or tablets, the administration directions for several medications approved for the treatment of ADHD (e.g., MAS extended release, methylphenidate extended release, dexmethylphenidate hydrochloride extended release, lisdexamfetamine) indicate that the contents of capsules may be sprinkled onto applesauce or mixed with yogurt or orange juice and specify that administration after a high-fat meal does not alter bioavailability. High-fat foods in particular have the potential to influence drug bioavailability by altering drug absorption in the gastrointestinal tract. Further, food–drug interactions can affect the bioavailability of drugs, resulting in therapeutic failure from decreased bioavailability or poor tolerability owing to increased bioavailability. Individuals who experience difficulty swallowing tablets or capsules often alter the dosage form (e.g., crushing/chewing tablets, emptying capsule contents into a soft food) to ease administration, which may alter the agent’s stability, efficacy, and safety. One method to increase the ease of taking medication is to eliminate the need to swallow a tablet or pill, which is an impediment to adherence in individuals who find it difficult to swallow tablets or capsules. Medication adherence is linked to several factors, including ease of drug administration. Across short-term efficacy studies, the safety and tolerability profile of SHP465 MAS was consistent with that of other long-acting psychostimulants. In 4- and 7-week forced-dose studies, SHP465 MAS produced significantly greater reductions in the ADHD Rating Scale With Adult Prompts (12.5 and 37.5 mg) and the ADHD Rating Scale, Version IV (25, 50, and 75 mg) total scores than placebo in adults with ADHD. In a 7-week dose-optimization study, significantly greater reductions from baseline in the ADHD Rating Scale, Version IV total score were observed with SHP465 MAS (12.5–75 mg) than with placebo in adults with ADHD. The short-term efficacy and safety of SHP465 MAS in adults with ADHD have been examined in multiple phase III studies. Each SHP465 MAS capsule contains three types of drug-releasing beads (one immediate-release bead and two different types of delayed-release beads) in a 1:1:1 ratio. SHP465 MAS contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate, and amphetamine aspartate monohydrate this results in a 3:1 mixture of d-amphetamine to l-amphetamine. (This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.SHP465 mixed amphetamine salts (MAS) extended release (Mydayis ® Shire, Lexington, MA, USA) is a once-daily, single-entity MAS capsule product for oral administration approved in USA for the treatment of attention-deficit/hyperactivity disorder (ADHD) in individuals aged 13 years and older. Amphetamine is used as a drug stimulant, leading to higher energy. It was seized under the Customs Act and the passenger arrested. The white powder was confirmed to be amphetamine that is worth Rs 4 crore. Initial examination of the passenger's baggage led to the recovery of a white powder that was concealed in the false bottom of the suitcase, the release stated. The authorities have arrested an Ethiopian national in this connection.Īcting on specific inputs, Customs sleuths intercepted the passenger upon his arrival from Addis Ababa on May 21, an official release stated. Nearly 2,000 grams of amphetamine worth about Rs 4 crore was seized at the international airport here, the Customs department said on Wednesday.
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