Development of dissolving microneedles for intradermal delivery of the long-acting antiretroviral drug bictegravir

BIC was formulated into nanosuspensions using wet media milling technique at a laboratory scale. BIC nanosuspensions were rationalised in terms of milling time, size of milling media and drug content. The rationalised nanosuspensions were lyophilised and incorporated into dissolving MNs.

Apart from this, MNs<br>containing crude BIC were also manufactured. These prepared MNs were characterised according to height reduction, insertion ability, dissolution study and ex vivo skin deposition. To investigate the pharmacokinetic profile of the BIC delivered from a such dissolving MN platform, a Sprague-Dawley rat model was used.

This drug delivery system has achieved a relevant plasma concentration for a period of 28 days. This Thesis provides the evidence concerning the<br>successfully intradermal delivery of BIC using this novel drug delivery system. To promote the commercialisation of the MN-based product, a variety of good manufacture practice (GMP) and quality control (QC) test need be well established and validated by the manufacturers.<br><br><i>Thesis is embargoed until 31 December 2027</i>.