OSTI

OROS

OROS (Osmotic-controlled Release Oral delivery System) is a proprietary technology used in the pharmaceutical industry to deliver drugs in a controlled manner. This system is designed to provide a consistent release of medication over an extended period, improving therapeutic outcomes and patient compliance.

Overview

The OROS system is a type of controlled release technology that utilizes osmotic pressure to deliver drugs at a predetermined rate. It is particularly useful for medications that require steady plasma concentrations to be effective. The system is often used for drugs with a narrow therapeutic index, where maintaining consistent drug levels is crucial.

Mechanism of Action

The OROS system consists of a tablet with a semi-permeable membrane surrounding a core containing the drug and osmotic agents. When the tablet is ingested, water from the gastrointestinal tract enters the tablet through the semi-permeable membrane. This influx of water dissolves the osmotic agents, creating pressure that pushes the drug out through a small orifice in the membrane.

Components

• Semi-permeable membrane: Allows water to enter but prevents the drug from diffusing out.
• Osmotic agents: Substances that create osmotic pressure when dissolved in water.
• Drug core: Contains the active pharmaceutical ingredient (API) and excipients.
• Orifice: A small hole through which the drug is released.

Advantages

• Consistent drug release: Provides a steady release of medication, reducing peaks and troughs in drug levels.
• Improved patient compliance: Reduces the frequency of dosing, which can improve adherence to medication regimens.
• Reduced side effects: By maintaining stable drug levels, the risk of side effects associated with peak concentrations is minimized.

Applications

OROS technology is used in various therapeutic areas, including:

• Cardiovascular diseases
• Central nervous system disorders
• Endocrine disorders

Examples of OROS Formulations

Some well-known medications that utilize OROS technology include:

• Concerta (methylphenidate) for Attention Deficit Hyperactivity Disorder (ADHD)
• Procardia XL (nifedipine) for hypertension
• Ditropan XL (oxybutynin) for overactive bladder

Challenges

While OROS technology offers many benefits, it also presents challenges such as:

• Complex manufacturing process: The production of OROS tablets is more complex and costly compared to conventional tablets.
• Potential for dose dumping: If the tablet is damaged, it may release the drug too quickly, leading to potential toxicity.

Also see

• Controlled release
• Pharmacokinetics
• Drug delivery systems
• Pharmaceutical formulation