DESIGN AND IN VITRO EVALUATION OF FAST DISSOLVING FILMS CONTAINING HP ÃŸ CD INCLUSION COMPLEXES OF LAMOTRIGINE
Objectives: The objectives of the present study is to design and evaluate fast dissolving films of lamotrigine using HP ÃŸ CD inclusion complexes with an aim to achieve rapid drug release thereby controlling the seizures in the shortest possible time.
Design: Inclusion complexes of lamotrigine were prepared with hydroxypropyl Î² cyclodextrin (HP Î² CD) employing different methods to improve the solubility and mask the bitter taste of the drug. Fast dissolving films were prepared by incorporating the developed inclusion complexes and using hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA) as film forming agents and other suitable excipients by solvent casting method.
Results: Inclusion complexes prepared by ultrasonication method resulted in better solubility and dissolution rate compared to other methods studied. The fast dissolving films prepared using inclusion complexes were found to be transparent and smooth in texture. The thickness, drug content, % moisture absorption and moisture loss, folding endurance and weight variation was found to be uniform. In vitro release profiles were inversely proportional to the polymer and directly proportional to superdisintegrant and plasticizer concentration. Optimized formulations (F8 and F12) were subjected for fourier transform infrared spectroscopy (FT-IR) and differential scanning calorimetry (DSC) which revealed the absence of any chemical interactions between the excipients of the formulation. The formulations were found to be stable without any significant changes during the stability studies carried out as per the ICH guidelines.
Conclusion: The study revealed the successful development of fast dissolving films of lamotrigine with promising results thereby suggesting the possible use of the developed films in the rapid management of epileptic seizures.Keywords: Fast dissolving films; epilepsy; lamotrigine; inclusion complex; HPMC; PVA; physico-chemical characterization.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).