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Question: What are the advantages of modified release solid oral dosage forms?

10 Oct 2022,2:23 AM

 

  1. The figure below is taken from a research article entitled 'Development of level A, B and C in vitro–in vivo correlations for modified-release levosimendan capsules'. Levosimendan is used for the treatment of congestive heart failure. The figure shows a plot of in vitro dissolution data versus in vivo absorption data for a lead candidate modified-release levosimendan oral capsule formulation.

 

Chart, scatter chart Description automatically generated

 

  1. What level of in vitro-in vivo correlation (IVIVC) do the data in the figure represent? Give a reason for your answer.

[10%]

  1. Across how many timepoints were the in vivo and in vitro data collected?

[10%]

  1. Explain how the ‘fractional dissolution in vitro’ data (plotted on the x-axis) would have been obtained.

[15%]

  1. Explain how the ‘fractional absorption in vivo’ data (plotted on the y-axis) would have been obtained.

[15%]

 

  1. Describe in detail, the FIVE main strategies for microneedle-enhanced transdermal drug delivery.

[50%]

 

(a)          Explain the main steps of wet granulation and list the functional excipients that may be used to improve the processability of these steps.

[50%]

(b)          Describe the optimal bioassay to test the activity of an:

  1. Antibacterial peptide
  2. Insulin biosimilar

[50%]

 

(a)          During the testing of a batch of tablets, the batch fails the content and weight uniformity assays. Discuss potential reasons for this failure.

[25%]

 

(b)         How could these potential problems be resolved?

[75%]

 

(a) What are the advantages of modified release solid oral dosage forms?

[80%]

 

(b) Give an example of when a modified release preparation may be used, explaining why it may be preferred over an immediate release formulation.

[20%]

 

(a)   Explain the challenges of conventional intraocular (periocular and intravitreal) injections.

[80%]

(b)   Describe the benefits of long-acting drug delivery systems in the treatment of ocular disorders.

[20%]

 

 

Expert answer

 

The advantages of modified release solid oral dosage forms are that they can provide a more controlled and sustained release of the active ingredient, which can result in improved patient compliance and efficacy. Additionally, they can minimize adverse effects by reducing the fluctuations in drug levels that can occur with traditional solid oral dosage forms. Modified release solid oral dosage forms are also easier to administer than other drug delivery systems, such as injectables or transdermal patches.

 

 

One disadvantage of modified release solid oral dosage forms is that they can be more expensive to produce than traditional solid oral dosage forms. Additionally, some patients may prefer the convenience of traditional solid oral dosage forms over modified release solid oral dosage forms. Finally, modified release solid oral dosage forms may not be suitable for all patients, particularly those who have a history of non-compliance with medication regimens.

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