TY - JOUR
T1 - Appraisal of the pharmacokinetic profile, histopathology, and stability studies of a fast dissolving oral film based on natural polysaccharide
AU - Sheikh, Fatima Akbar
AU - Aamir, Muhammad Naeem
AU - Haseeb, Muhammad Tahir
AU - Shah, Muhammad Ajmal
AU - Farid-Ul-Haq, Muhammad
AU - Alqarni, Mohammed
AU - Vargas-De-La-Cruz, Celia
AU - Blundell, Renald
N1 - Publisher Copyright:
© 2022 Pakistan Journal of Pharmaceutical Sciences. All rights reserved.
PY - 2022/5
Y1 - 2022/5
N2 - The present research is designed to evaluate the pharmacokinetic profile, histological evaluation, and stability studies of an orodispersible film (ODF) of tizanidine (TZ) and meloxicam (MX) prepared from a natural polysaccharide, i.e., xanthan gum. In vivo release study of TZ and MX was performed in rabbits and results indicated the better pharmacokinetics parameters and improved the oral bioavailability when compared to the oral aqueous suspension and solution of TZ and MX, respectively. The intermediate stability studies were performed at 30±2°C and 65±5% RH, whereas, the accelerated stability studies were carried out at 40±2°C and 75±5% RH, respectively for the duration of six months and results indicated that the ODF was stable for six months without any substantial difference in essential physico-chemical parameters, mechanical attributes, and morphological constraints. The toxicity profile of ODF was determined through histopathology of vital organs after administering the ODF to the rabbits. Histopathology revealed that the tissues of all vital organs are normal and did not exhibit any abnormalities, lesions, or hemorrhage. Therefore, the ODF prepared from xanthan gum exhibited a non-toxic and stable formulation with a better pharmacokinetics profile of MX and TZ.
AB - The present research is designed to evaluate the pharmacokinetic profile, histological evaluation, and stability studies of an orodispersible film (ODF) of tizanidine (TZ) and meloxicam (MX) prepared from a natural polysaccharide, i.e., xanthan gum. In vivo release study of TZ and MX was performed in rabbits and results indicated the better pharmacokinetics parameters and improved the oral bioavailability when compared to the oral aqueous suspension and solution of TZ and MX, respectively. The intermediate stability studies were performed at 30±2°C and 65±5% RH, whereas, the accelerated stability studies were carried out at 40±2°C and 75±5% RH, respectively for the duration of six months and results indicated that the ODF was stable for six months without any substantial difference in essential physico-chemical parameters, mechanical attributes, and morphological constraints. The toxicity profile of ODF was determined through histopathology of vital organs after administering the ODF to the rabbits. Histopathology revealed that the tissues of all vital organs are normal and did not exhibit any abnormalities, lesions, or hemorrhage. Therefore, the ODF prepared from xanthan gum exhibited a non-toxic and stable formulation with a better pharmacokinetics profile of MX and TZ.
KW - fast dissolving film
KW - orodispersible
KW - polymeric film
KW - Polysaccharides
KW - solvent casting method
UR - http://www.scopus.com/inward/record.url?scp=85132354789&partnerID=8YFLogxK
U2 - 10.36721/PJPS.2022.35.3.SP.937-944.1
DO - 10.36721/PJPS.2022.35.3.SP.937-944.1
M3 - Artículo
AN - SCOPUS:85132354789
VL - 35
SP - 937
EP - 944
JO - Pakistan Journal of Pharmaceutical Sciences
JF - Pakistan Journal of Pharmaceutical Sciences
SN - 1011-601X
IS - 3
ER -