Who does Modified Release Drug Products Help the Most?
Modified release drug delivery systems are mainly developed to control the rate site of drug release. Some advantages of using modified-release drug products include improved efficiency, reduced adverse effects, and increased convenience in patients’ compliance end performance.
The usage of modified-release drug products offers more advantages to manufacturers. For example, it is easy to alter the drug dosage by using different excipients while filling capsules with pellets. In addition, combining at least two or more drug products in a single dose is also possible to obtain a fixed dosage combination.
The demand for modified release (MR) drug products
Several elements are driving the demand for modified-release drug products. For instance, manufacturers are more interested in developing new products with improved features based on the existing molecules. Even though the products offer lower income than the new chemical entities, search products have lower development costs and few associated risks as compared to the new chemical entities.
There have been different medicines in the past 15 years as several blockbuster products have reached the end of patent protection and have become accessible on the generic market. MR products also offer several potential benefits. The main benefits can be achieved as referred to as extended-release and delayed-release.
Some benefits of modified-release oral dosage:
The modified release dosage forms can be separated into two forms that are monolithic and multiple-unit formulations. The monolithic structures generally include a simple manufacturing process as they can be produced using a typical tableting method.
Multiple unit preparations like pellets require a challenging manufacturing process and provide minor variable progression in the gastrointestinal tract. The adjustment of the doors can be made without any formulation modification because the mass of the pellets can be modified to contain the correct dosage. Furthermore, the enteric coating delivers pH-sensitive or time-controlled polymer coatings for pellet formulation that controls drug release.
- Sustained blood levels
Extended-release pellets are helpful for all drugs with a shorter than optimal half-life. They can maintain therapeutic blood level concentrations over prolonged periods with once-daily usage. Furthermore, adverse side effects resulting from transiently high concentrations can be avoided greatly.
- Improved convenience and patient compliance:
Drugs generally need to be given at frequent intervals throughout the day to maintain better blood concentration levels within the desired therapeutic range. The potential reduction of daily dosages offered by extended-release products can improve patient compliance and also help in avoiding missed doses.
- Protect acid-sensitive drugs:
The enteric coating is generally used to protect the product until it has passed the gastric bladder and reached the gut. It serves to preserve acid-sensitive drugs from gastric acid and might reduce the likelihood of certain drugs irritating the stomach.
Perks of FDCs (Fixed-dose combination):
Fixed dosages have advantages when there is a patient population for whom treatment with a specific combination of APIs in a fixed ratio of dosages has been considered safe and effective and contributes to the therapeutic effect overall.
The development of fixed dosages is being driven by several health concerns as they continue to be increasingly used in managing highly infectious diseases like HIV-AIDS, Malaria, and Tuberculosis, which are considered the major infectious diseases. They also help improve patient compliance and convenience of administration as they decrease the number of dosages required every day.
Challenges in Modified Release Drug Products
A lot of progress has been made in developing high-performance polymers in the past decade. But developing MR formulations with alcohol-resistant properties remains a challenge. When an MR product is consumed with alcohol, the mechanism can be affected adversely, which could lead to dose dumping. In the case of some elements like opioids, dose dumping can result in serious adverse events.
In addition, the development of modified-release drug products requires highly specialized equipment and regulatory knowledge. Unfortunately, several pharmaceutical companies neither have a sufficient number of projects nor the in-house expertise to justify the investment in these capabilities.
Modified release drug products offer several advantages with the ability to control the rate and the site of drug release to reach the clinical objectives which cannot be achieved easily using the conventional dosage. The technology offers amazing benefits that allow people to modify the rate of release and also reduce the dosage numbers gradually and MR formulation development needs highly specialized equipment and regulatory knowledge to completely facilitate the capabilities.
About ZIM Laboratories
ZIM Labs is an innovative drug delivery solution provider focusing on improving patient convenience and adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes for the production and supply of innovative and differentiated generic pharmaceutical products to our customers globally. At ZIM Labs we provide our customers a comprehensive range of value-added solid dosage differentiated generic products in semi-finished and finished categories/formulations. These include granules, pellet (immediate, sustained, modified, extended-release), taste-masked powders, suspensions, tablets, capsules, and recently developed Oral Thin Films (OTF).