Taking control of sustained drug release – with Parteck® SRP 80 – see the video

Patient convenience and compliance are major targets in pharmaceutical drug formulation, which is why solid oral formulations are some of the most well established dosage forms in the world. In many cases, long-acting efficacy of the API is required.

The new Parteck® SRP 80 is a highly functional excipient that offers superior reliability and consistency in sustained release products. This video provides an overview of different release profiles, with a focus on sustained release, followed by technical information on how Parteck® SRP 80 enhances sustained release formulations including data on its dissolution performance.

More information on Parteck SRP 80:

• Article American Pharmaceutical Review
• Webinar
• Poster

See the full transcript of the video here:

Patient convenience and compliance are major targets in pharmaceutical drug formulation which is why solid oral formulations are some of the most well-established dosage forms in the world. In many cases, long-acting efficacy of the API is required.

The new Parteck® SRP 80 is a highly functional excipient that offers exactly the superior reliability and consistency that you’re looking for in your sustained-release products. The release of active pharmaceutical ingredients can follow a variety of different profiles depending on the respective aims regarding efficacy and bioavailability. From immediate release to delayed-release –  from pulsatile release to sustained release.

Immediate conventional release of the drug leads to fast effect of the API for the patient. Delayed-release follows a similar pattern but the release shows a definable time lag which is usually triggered by a pH-dependent coating of the dosage form. This coating prevents the API from being released in the acidic gastric environment but then allows the release to start when the drug reaches the intestine with a higher ph value. With pulsatile release the active ingredient is released in a steadily repeating pattern over a longer amount of time. Sustained-release, on the other hand, manages to achieve a steady release curve maximizing the time frame in the therapeutic window of the API. This reduces not only the risk of toxic side effects which can occur by exceeding the maximum tolerated dose but also the intake frequency. Thereby increasing patient compliance such as the new Parteck SRP 80. Parteck SRP 80 is based on polyvinyl alcohol PVA. Its advanced matrix diffusion technology helps increase the efficacy and bioavailability of your compound.

The smart matrix structure of Parteck SRP 80 ensures consistent sustainable drug delivery over long release periods. In order to release the API reproducibly over time, the matrix needs to be homogeneous. With its synthetic origin and specified particle size, Parteck SRP 80 is highly adapted for consistent matrix quality.  Tableting formulations with Parteck SRP 80 exhibit good flowability,  high compressibility as well as high processivity through low ejection forces allowing high throughput direct compression processes.  This ensures simplified feasibility and accelerates your formulation work to rapid and cost-efficient manufacturing.

To test the dissolution of our new excipient in compliance with the major pharmacopeias we have simulated the release of API from the dosage form in a series of in vitro dissolution tests. The choice of medium depends on which part of the gastrointestinal passage needs to be simulated as well as the API of the formulation.

Let’s take a closer look at the dissolution performance itself. We are following the dissolution of our model drug propranolol in simulated gastric fluid over a timespan of 12 hours. The tablet swells and slowly erodes. The API is slowly but steadily released by diffusing through the matrix structure of Parteck SRP 80. Parteck SRP 80 and its performance are unsusceptible to variations in compaction force. It offers consistent API release profiles for a broad range of compression forces and respective degrees of tablet hardness ensuring high robustness for the manufacturing process of the final tablets.

In order to achieve the desired API concentration over such a prolonged time, tablets with sustainable release properties must contain larger API amounts than single-dose formulations. But with higher dosages come higher risks. Dosage dumping defined as the unintended release of the entire API in a short period of time can lead to significant and potentially dangerous toxic effects. It can be brought upon the patient through unauthorized dose division, crushing or misconduct in the intake of the drug.

Accompanying food and beverage consumption including alcohol can also influence the API release in an undesired way. To prevent such errors dosage forms can be equipped with an excipient which creates a matrix system. This series of dissolution tests illustrates the release of the API in different media. Their varying pH values resemble different sections of the gastrointestinal tract. They can also give an indication to varying pH values in the gastrointestinal system before and after food and beverage intake. As the displayed graph demonstrates the sustaining matrix shows reliable and consistent API release over a broad pH range indicating robustness against pH variations.

What’s more, the sustained release of the API is practically unaffected by the presence of alcohol. Overall we have seen that Parteck SRP 80 is a highly functional excipient for sustained-release oral solid formulations ensuring robust and dependable performance. Its suitability for high throughput direct compression processes accelerates your formulation work and enables rapid and cost-efficient manufacturing. This is how Millipore Sigma provides superior reliability and consistency for your drug formulation and that’s how you can take control of sustained release.

The new Parteck SRP 80.