10.6084/m9.figshare.4737898.v1
Aurica P. Chiriac
Aurica P.
Chiriac
Alina Diaconu
Alina
Diaconu
Loredana E. Nita
Loredana E.
Nita
Nita Tudorachi
Nita
Tudorachi
Liliana Mititelu-Tartau
Liliana
Mititelu-Tartau
Andreea Creteanu
Andreea
Creteanu
Oana Dragostin
Oana
Dragostin
Daniela Rusu
Daniela
Rusu
Gratiela Popa
Gratiela
Popa
The influence of excipients on physical and pharmaceutical properties of oral lyophilisates containing a pregabalin-acetaminophen combination
Taylor & Francis Group
2017
Pregabalin-acetaminophen combination
mannitol
microcrystalline cellulose
hydroxypropyl methylcellulose
thermal analysis
near infrared chemical imaging
2017-03-09 17:16:30
Journal contribution
https://tandf.figshare.com/articles/journal_contribution/The_influence_of_excipients_on_physical_and_pharmaceutical_properties_of_oral_lyophilisates_containing_a_pregabalin-acetaminophen_combination/4737898
<p><b>Objectives:</b> The purpose of the study was to investigate and characterize the oral lyophilisates containing the pregabalin-acetaminophen drug combination and as xcipients mannitol with microcrystalline cellulose or hydroxypropyl methylcellulose, in order to conclude upon drug-excipient interactions and their stability implications, impact of excipients on drug release and on the physicochemical and mechanical properties of the pharmaceutical formulations.</p> <p><b>Methods:</b> The oral tablets were made by using a Christ freeze-dryer alpha 2–4-LSC lyophilizer, and evaluated for stability, drug-excipient compatibility and homogeneity of the prepared pharmaceutical formulations. The formulations were evaluated for <i>in vivo</i> absorption in rabbits by histopathological exams.</p> <p><b>Results:</b> FTIR and thermogravimetric analyses, DLS technique, SEM and NIR-CI studies confirmed the compatibility between compounds. From the determined physical and biochemical parameters of the formulations it was established that they are stable, homogeneous, and meet the conditions for orally disintegrating tablets.</p> <p><b>Conclusion:</b> In the case of the investigated pharmaceutical formulations the study evidenced the assembling through physical bonds between the excipients and the ‘codrug’ complex, which do not affect the release of the bioactive compounds.</p>