Capsules, a versatile OSD for early phase development
Capsules, a versatile OSD for early phase development
In this webinar the essential aspects of oral solid dosage forms will be evaluated, especially a comparison between capsules and tablets will help to select the ideal formulation for your scope. You will be guided through the capsule development process from early phase development to larger scale manufacturing, emphasizing the critical process aspects that have to be controlled from a formulation point of view to obtain a successful product.
Capsules and tablets are the most popular oral solid dosage forms for the manufacturing of oral medication and food supplements. Although they often share the same target profile, both have distinct advantages and disadvantages. Understanding the different aspects such as patient compliance, the manufacturing process and the desired release profile of the formulation lead to a better selection of the most suitable oral solid dosage form.
In early phase development, capsules play a significant role in helping the API (active pharmaceutical ingredient) enter Phase I clinical trial as limited formulation (blend) development is required. Furthermore, capsules can be filled with pure API, limiting the consumption of API, avoiding development time and thereby reducing financial investment. Moreover, capsules provide excellent versatility in dose selection, taste masking and blinding properties, which are essential features for clinical studies.
For later stages in clinical trials, a more sophisticated blend in capsule formulation is needed to reduce the manufacturing time and to efficiently produce drug products using (semi-)automatic device. The challenges related to the capsule manufacturing in these phases are mainly linked to the homogeneity of the blend to be filled into capsules, needed to guarantee an accurate dose and scale-up problems related to the transfer from manual encapsulation devices to automated machines.
Capsules and tablets are the most popular oral solid dosage forms for the manufacturing of oral medication and food supplements. Although they often share the same target profile, both have distinct advantages and disadvantages. Understanding the different aspects such as patient compliance, the manufacturing process and the desired release profile of the formulation lead to a better selection of the most suitable oral solid dosage form.
In early phase development, capsules play a significant role in helping the API (active pharmaceutical ingredient) enter Phase I clinical trial as limited formulation (blend) development is required. Furthermore, capsules can be filled with pure API, limiting the consumption of API, avoiding development time and thereby reducing financial investment. Moreover, capsules provide excellent versatility in dose selection, taste masking and blinding properties, which are essential features for clinical studies.
For later stages in clinical trials, a more sophisticated blend in capsule formulation is needed to reduce the manufacturing time and to efficiently produce drug products using (semi-)automatic device. The challenges related to the capsule manufacturing in these phases are mainly linked to the homogeneity of the blend to be filled into capsules, needed to guarantee an accurate dose and scale-up problems related to the transfer from manual encapsulation devices to automated machines.
