Manufacturing and Assessing the New Orally Disintegrating Tablets, Containing Nimodipine-hydroxypropyl-β-cyclodextrin and Nimodipine-methyl-β-cyclodextrin Inclusion Complexes.
Marian Novac, Adina Magdalena Musuc, Emma Adriana Ozon, Iulian Sarbu, Mirela Adriana Mitu, Adriana Rusu, Daniela Gheorghe, Simona Petrescu, Irina Atkinson, Dumitru Lupuliasa
Author Information
Marian Novac: Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, "Carol Davila" University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania.
Adina Magdalena Musuc: "Ilie Murgulescu" Institute of Physical Chemistry, 202 Spl. Independentei, 060021 Bucharest, Romania. ORCID
Emma Adriana Ozon: Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, "Carol Davila" University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania.
Iulian Sarbu: Department of Pharmaceutical Physics and Biophysics, Drug Industry and Pharmaceutical Biotechnologies, Faculty of Pharmacy, "Titu Maiorescu" University, 004051 Bucharest, Romania. ORCID
Mirela Adriana Mitu: Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, "Carol Davila" University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania. ORCID
Adriana Rusu: "Ilie Murgulescu" Institute of Physical Chemistry, 202 Spl. Independentei, 060021 Bucharest, Romania.
Daniela Gheorghe: "Ilie Murgulescu" Institute of Physical Chemistry, 202 Spl. Independentei, 060021 Bucharest, Romania.
Simona Petrescu: "Ilie Murgulescu" Institute of Physical Chemistry, 202 Spl. Independentei, 060021 Bucharest, Romania.
Irina Atkinson: "Ilie Murgulescu" Institute of Physical Chemistry, 202 Spl. Independentei, 060021 Bucharest, Romania.
Dumitru Lupuliasa: Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, "Carol Davila" University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania.
The aim of the present study was to manufacture new orally disintegrating tablets containing nimodipine-hydroxypropyl-β-cyclodextrin and nimodipine-methyl-β-cyclodextrin inclusion complexes. For obtaining a better quality of the manufactured tablets, three methods of the preparation of inclusion complexes, in a 1:1 molar ratio, were used comparatively; namely, a solid-state kneading method and two liquid state coprecipitation and lyophilization techniques. The physical and chemical properties of the obtained inclusion complexes, as well as their physical mixtures, were investigated using Fourier transformed infrared spectroscopy, scanning electron microscopy, X-ray diffraction analyses, and differential scanning calorimetry. The results showed that the lyophilization method can be successfully used for a better complexation. Finally, the formulation and precompression studies for tablets for oral dispersion, containing Nim-HP-β-CD and Nim-Me-β-CD inclusion complexes, were successfully assessed.
