Oral Liquid Dosage Formulation Development
Liquid oral dosage forms, such as solutions and suspensions, provide unique benefits for patients who have difficulty swallowing solid oral dosage forms – capsules or tablets – and are the preferred choice of drug administration for pediatric and geriatric patients. Most pharmaceutical suspensions are solid, insoluble drug particles dispersed within a liquid vehicle.
Advantages of Suspensions
Liquid oral dosage forms offer additional advantages including:
Rapid Development for New Chemical Entities (NCE)
The majority of new drugs in the pharmaceutical NCE pipeline have poor solubility. Oral suspensions as a dosage form offer a quick, convenient solution for many of these active molecules to mitigate this obstacle and move them along the pathway to early phase clinical studies.
Improved Stability (compared to solution dosage forms)
The fragility of certain drug molecules can make them prone to degradation in some dosage forms. In such cases, these drugs can be converted into more insoluble derivatives and formulated as suspensions. This in turn can improve drug stability. Some drugs can even degrade in the presence of water – these can be formulated using non-aqueous vehicles such as oils.
Improved Bioavailability (compared to solid oral dosage forms)
Suspension formulations provide a larger surface area for the drug to dissolve. Where tablets and capsules need to disintegrate before the API can begin dissolving, suspension products can bypass this step and begin being absorbed instantly into systemic circulation. Removing this step allows for drugs in suspension products to dissolve more quickly, which in turn can improve bioavailability.
Sustained Release
For poorly soluble APIs, the drug dissolution rate can be controlled through formulation factors such as particle size, pH, and solubilizing agents. Sustained release can also be achieved through special formulation technologies using ion-exchange resins, polymer coating, and/or non-aqueous vehicles. These types of products are more challenging to formulate and manufacture, but they can provide better protection of intellectual property (IP).
Taste Masking
Some drugs have an innately bitter or unpleasant taste. Suspensions can reduce this sometimes difficult inconvenience by using insoluble salt forms, pH control, and/or a polymer coating.
Dose Titration
Single stock-keeping units (SKU) can cover a wide range of dosing strengths by using dosing syringes or graduated dosing cups. This reduces the cost of development, manufacturing, and inventory management.
At Vici Health Sciences, our scientists have in-depth knowledge, extensive prior experience, and a plethora of tools to help you develop your formulation. From oral to liquid dosage conversions to taste-masking, Vici can tailor your drug products to fit your needs and the needs of your patients. Contact us to find out more about how we help you with your pharmaceutical R&D journey today.