Clinical trials face new challenges every day. It is estimated that 90% of drugs at the development stage do not make it to the market. The reasons behind such a high percentage vary, and some of the most important are related to the oral dosage forms used for medical trials purposes. That is why companies should look for the most suitable clinical trial capsules.
To reduce the time and financial burden of drugs failing to make it to market, different factors must be considered such as blinding, dosage, appearance, formulation, and time.
To properly minimize bias and maximize the validity of the results of clinical trials, investigators should prevent the identification of a capsule with the active medication from the control group capsules which contain the placebo. There are different ways to attain this goal.
Over-encapsulation is the most used and known method for blinding. In this process, the medication is placed into an opaque capsule so the patient can’t see what is inside. This may sound like a simple process, but there are other factors to take into account such as size, color, and back-fill material.
Over-encapsulation should also prevent the ‘shadowing effect’, which can let the patients see the medicine through the capsule. This issue can be fixed with the correct measurement and size of the clinical trial capsule.
In some studies, the evidence suggests a correlation between the appearance and design of a capsule and how individuals perceive the medicine. Thus, color, shape, size, and coating have an impact on the results of clinical trials.
Those features influence the expectations that the patients may have on the medicine. For example, in an investigation run by Buckalew and Coffield (1982), the investigators concluded that capsules are perceived as stronger than tablets, and larger capsules are seen as stronger in comparison to smaller ones.
Additionally, to ensure your medicine succeeds at all stages of the process of clinical trials, it is crucial for you to establish the right dosage, which involves the capsules you use. Usually, capsules are smaller in medical trials, that is why you should always look up for options that allow you to customize the capsule depending on your trial needs.
Choosing the right capsule size will also prevent the rattle of the medicine inside of it, reducing the chances of the patient identifying the content of the clinical trial capsule vs the placebo capsule. The ingredients used to create the capsule are also important to avoid such identification.
Not all capsules for clinical trials are the same. They vary depending on the composition and presentation of the medicine you are testing, like dry powders, semisolids, or non aqueous liquids, among others.
According to the GMP regulations for clinical trial material, you need to provide data that shows that the encapsulation of your clinical trial capsules does not interfere with the quality of the medicine being tested.
This is why you should choose trusted companies that guarantee the capsules are adjusted to the type of medicine you are testing in terms of dissolution, disintegration, and bioequivalence.
Keep learning about capsule technology trends...
The process for clinical trials can be very long. According to the FDA, the length of a clinical trial generally increases with each clinical trial phase.
Normally, capsule development and testing is conducted in standard clear capsules, which can lead to delays, or even to a restart the entire development process due to changes in the API, capsule dye color, among other factors.
You need a method that can leverage the studies of clinical stability in previous stages to support your final dosage.
CapsCanada FM-CAPS® provide an R&D solution for pharmaceutical formulation developments with the following benefits:
Learn more about FM-CAPS®