The One Tablet Trend – a Repost from IOI Oleochemical
A trend that we are seeing in the market in the USA is the improvement of patient compliance: ,,Take 1 tablet instead of having to think about regularly taking 3 tablets a day.” As a rule, patients’ cooperation in regularly taking medication in the right dose and at the right time is a critical factor for the success of treatment not carried out under the supervision of healthcare professionals.
Depending on the individual’s living situation, this requirement cannot always be fully met because the patient’s personal life is restricted or the regular medication intake is not practicable due to age or illness. A trend that we are seeing in the USA addresses just this topic. The goal is to ensure the release of the active ingredients over a longer period after administration. This enables longer intervals between doses and, as a result, improved quality of personal life and an increased chance of successful treatment.
The development of dosage forms with a sustained release of active ingredients requires special expertise and changes to the functional demands and expectations regarding the excipients as compared to conventional concepts with immediate release.
If one considers the following factors, the scope of the challenges for galenic formulators becomes clear. According to the Biopharmaceutical Classification System (BCS), more than 70% of the active pharmaceutical ingredients and active pharmaceutical ingredient candidates (APIs) are difficult to formulate due to poor solubility in water and poor diffusibility.
The use of surface-active substances is an established strategy for addressing this technical challenge. Ethoxylated raw materials are often used for this purpose; however, their origin, chemistry, purity and batch-to-batch consistency can also pose distinctive implications.
Today, multiple techniques are applied for e.g. coating of solid dosage forms with a favourable, sustained release profile, not only for BCS active ingredients with poor solubility in water. Melt coating processes are a popular strategy. The ability of the excipient system to consistently ensure the expected release profile over as long a period as possible is a decisive criterion for successful developments. Up to now, a tendency for polymorphism, the diversity of crystallisation and energy states, has presented a considerable obstacle in the application in the area of lipid-based materials.
This is where IOI Oleo GmbH’s decades of experience and expertise in the development and production of lipid-based excipients comes into play. They have developed a toolbox of excipients that unites the desired properties, highest purity, batch-to-batch consistency and are polymorphic free.
