Testing of Vyvanse capsules

Introduction and scope

Lisdexamfetamine dimesilate, the active ingredient in Vyvanse capsules, is a medicine for the treatment of attention deficit hyperactivity disorder (ADHD), and moderate to severe binge eating disorder in adults when nonpharmacological treatment is unsuccessful or unavailable.  Approved therapeutic indications and other information to support safe and quality use of Vyvanse are outlined in the Australian Product Information (PI). In Australia products are available on prescription in 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg strengths. 

The Therapeutic Goods Administration (TGA) had observed an unexpected increase in the number of adverse event reports for Vyvanse. These included reports about the lack of efficacy and concerns about the quality and safety.

In response to the increased adverse event reports, the TGA has investigated Vyvanse products, which included laboratory testing. The purpose of this testing was to assess the quality of the six different strengths of Vyvanse products. The outcomes of the testing results are summarised below.

Testing

Samples

Vyvanse products were obtained from either the sponsor or from the market. The samples for this testing represented the 6 different strengths of Vyvanse capsules available.

Analytical method and testing specifications

The TGA Laboratories tested the products for content of the active ingredient, the levels of any related substances or impurities, dissolution, and uniformity of dosage units. The sponsor’s acceptance requirements were applied to the results to assess compliance. The TGA evaluates the safety, quality and efficacy of prescription medicines before they are approved for registration in the Australian Register of Therapeutic Goods (ARTG). As part of this process, quality requirements are agreed upon by TGA.

The Vyvanse samples were tested for the following:

• Content of Lisdexamfetamine dimesilate
  • This test measures the amount of the active ingredient (Lisdexamfetamine dimesilate) present in the capsules. For the Vyvanse capsules to comply with the requirements, the amount of Lisdexamfetamine dimesilate must be in the range of 92.5 to 105.0% of the labelled amount.
• Uniformity of dosage units
  • This test measures the variation of the active ingredient across individual capsules.
• Dissolution
  • This test measures the amount of the active ingredient that has dissolved at a specified time. Compliance with this test indicates that the active ingredient will be available to be absorbed.
• Related substances
  • This test measures the level of impurities present in the products. To comply with the requirements of this test the level of impurities detected in the Vyvanse capsules must be below the requirements.

Testing results

All 6 samples complied with the requirements of the tests for content of the active ingredient, levels of impurities, dissolution and uniformity of dosage units. The testing results are summarised in Table 1 below.

Conclusion

The tested batches of Vyvanse capsules met the specified quality requirements.

Results