Platform: Customized Drug Release

Partner with Aptalis Pharmaceutical Technologies to apply these Customized Drug Release technologies to a drug in your pipeline to create a product with proven characteristics. Or leverage brand loyalty and extend your brand’s lifecycle by creating a formulation that adds clinical benefits, increases patient compliance and dosing convenience.

Optimizing a drug’s performance is important to both patients and pharmaceutical companies and a contributing factor to improving healthcare outcomes. For patients, increased adherence to prescribed dosing regimens is closely tied to both better drug tolerability¹ and decreased dosing frequency². Studies have shown higher rates of adherence with once-daily dosing compared with twice- or thrice daily dosing². For pharmaceutical companies, a formulation may be a differentiating factor in a competitive market.

Our proprietary customized drug release technologies allow for the development of formulations that meet medical needs. These commercially-proven technologies can be used alone or in combination to improve efficacy, enhance safety, and increase patient compliance.

Patient Advantages of Products with Customized Release Profiles

• Less frequent dosing and fewer pills may improve convenience and compliance
• Reduced potential of overmedicating to achieve satisfactory effect - drug can be targeted for release in a specific region of the GI tract for optimal absorption and efficacy
• Potentially improved tolerability due to a lower peak drug concentration

Our customized release Pharmaceutical Technologies provide a wide variety of customized release profiles that can be tailored to optimize a drug’s therapeutic performance. A drug may require both rapid onset of action and sustained release within a single dosage unit (timed sustained release or TSR profile), while a different drug may require escalation of physiological drug levels rapidly after a defined delay (timed pulsatile release or TPR profile). Other drugs may be part of a combination product that requires different release profiles for each active ingredient. Our proprietary technologies can be used alone or in combination to develop formulation solutions for a variety of needs.

Flexible Technologies Support a Full Spectrum of Customized Release Profiles

Our customized release approaches provide for the development of formulations with a wide variety of release profiles.

Within the range of modified release profiles exist a number of custom profiles including:

Timed Sustained Release

Timed Pulsatile Release

Chrono Release

In addition to various release profiles, our proprietary technology can incorporate targeted delivery, enabling drug release at a specific region in the GI tract. This will allow a drug to be absorbed more effectively into the body or, in instances where the drug is required to act topically within the GI tract, to ensure that it has the optimal effect. This is ideal in cases where pH stability of the compound, physiology of the digestive tract, GI disease state and/or absorption window can impact therapeutic effectiveness.

1. Saini SD, Schoenfeld P, Kaulback K, et al. Effect of medication dosing frequency on adherence in chronic diseases. Am J Manag Care. 2009;15:e22-33.
2. Roose SP. Tolerability and patient compliance. J Clin Psychiatry. 1999;60 Suppl 17:14-17.