Description

ORA-Plus Suspension Vehicle, crafted by Perrigo, is an innovative solution designed to streamline the compounding of oral liquid medications. This aqueous-based, thixotropic liquid serves as a reliable base for creating uniform and stable oral suspensions, accommodating a wide range of active pharmaceutical ingredients (APIs).

Key Features

• Translucent and Milky White: The liquid's unique appearance ensures easy handling and measurement.
• Thixotropic Properties: Enhances the stability and homogeneity of the suspension.
• Unflavored and Unsweetened: Free from sugar, alcohol, and dyes, making it suitable for diverse medicinal needs.
• Bland Taste: Provides versatility in compounding without altering the intended flavor profile.

Formulation Benefits

Buffered to a slightly acidic pH of approximately 4.0 to 4.5, ORA-Plus minimizes the degradation and oxidation of medicinal agents. It includes anti-foam agents to reduce foaming during shaking, ensuring ease of use. The formulation remains stable at both room temperature and under refrigeration, passing the USP preservative effectiveness test <51>.

Compatibility and Versatility

ORA-Plus exhibits excellent compatibility with APIs and retains its suspending properties even when diluted up to 50% with water, flavoring agents, syrups, or alcohol. It is particularly suitable for pediatric, geriatric, and naso-gastric suspensions. Often combined with ORA-Sweet or ORA-Sweet SF, it helps create pleasant-tasting suspensions.

Packaging and Use

Typically packaged in 473 mL amber glass or plastic PET bottles, ORA-Plus is designed for practical use in pharmaceutical settings. Its ability to wet and levigate powdered drugs before achieving the final volume ensures a smooth and uniform suspension.

Ingredients

The formulation includes:

• Purified water
• Microcrystalline cellulose
• Carboxymethylcellulose sodium
• Xanthan gum
• Carrageenan
• Calcium sulfate
• Trisodium phosphate
• Citric acid
• Sodium phosphate
• Dimethicone antifoam emulsion
• Methylparaben
• Potassium sorbate

Physical Properties

• pH Level: Approximately 4.2
• Viscosity: Ranges from 400 to 6700 cps at 25°C
• Osmolality: Between 157 and 230 mOsm/kg

Stability and Studies

With over 150 stability studies conducted, ORA-Plus demonstrates robust stability characteristics. The compounded suspensions' stability depends on the API and storage conditions, with some formulations remaining stable for up to 180 days.

Contraindications

ORA-Plus is contraindicated in individuals with hypersensitivity to any of its ingredients, ensuring safe and effective use for those without such sensitivities.