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Preparation and Comparative Bioavailability Studies of Indomethacin-Loaded Cetyl Alcohol Microspheres.

Gupta NV, Gowda DV, Balamuralidhara V, Khan MS - J Pharm (Cairo) (2012)

Bottom Line: DSC, FTIR spectroscopy and stability studies indicated that the drug after encapsulation with fat microspheres was stable and compatible.Both formulations were found to be bioequivalent as evidenced by in vivo studies.Based on this study, it can be concluded that cetyl alcohol microspheres and Microcid SR capsule are bioequivalent in terms of the rate and extent of absorption.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagar, Karnataka, Mysore 570015, India.

ABSTRACT
The purpose of the present study was to compare the in vitro release and to find out whether the bioavailability of a 75 mg indomethacin capsule (Microcid SR) was equivalent to optimized formulation (indomethacin-loaded cetyl alcohol microspheres). Indomethacin-loaded cetyl alcohol microspheres were prepared by meltable emulsified cooling-induced technique. Surface morphology of microspheres has been evaluated using scanning electron microscopy. A single dose, randomized, complete cross over study of IM microspheres was carried out on 10 healthy male and female Albino sheep's under fasting conditions. The plasma was separated and the concentrations of the drug were determined by HPLC-UV method. Plasma indomethacin concentrations and other pharmacokinetic parameters obtained were statistically analyzed. The SEM images revealed the spherical shape of fat microspheres, and more than 98.0% of the isolated microspheres were in the size range 12-32 μm. DSC, FTIR spectroscopy and stability studies indicated that the drug after encapsulation with fat microspheres was stable and compatible. Both formulations were found to be bioequivalent as evidenced by in vivo studies. Based on this study, it can be concluded that cetyl alcohol microspheres and Microcid SR capsule are bioequivalent in terms of the rate and extent of absorption.

No MeSH data available.


Related in: MedlinePlus

FTIR spectra of cetyl alcohol (peak a), indomethacin (peak b), and indomethacin-loaded cetyl alcohol microspheres (peak c:F3).
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fig3: FTIR spectra of cetyl alcohol (peak a), indomethacin (peak b), and indomethacin-loaded cetyl alcohol microspheres (peak c:F3).

Mentions: FTIR spectra for IM and formulation F3 are shown in Figure 3. The characteristic IR absorption peaks of IM comparing the IR spectra at 3413 (aromatic C–H stretching), 2618 (carboxylic acid stretching), 1695 (C=O stretching), 1600 (C=C stretching), 1452 (O–CH3 deformation), and 1236 cm−1 (O–H deformation) were not altered after successful encapsulation of drug, indicating no chemical interactions between the drug and CA used. A comparison and an interpretation of this region in our spectra agree with their conclusions [14, 18].


Preparation and Comparative Bioavailability Studies of Indomethacin-Loaded Cetyl Alcohol Microspheres.

Gupta NV, Gowda DV, Balamuralidhara V, Khan MS - J Pharm (Cairo) (2012)

FTIR spectra of cetyl alcohol (peak a), indomethacin (peak b), and indomethacin-loaded cetyl alcohol microspheres (peak c:F3).
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4595941&req=5

fig3: FTIR spectra of cetyl alcohol (peak a), indomethacin (peak b), and indomethacin-loaded cetyl alcohol microspheres (peak c:F3).
Mentions: FTIR spectra for IM and formulation F3 are shown in Figure 3. The characteristic IR absorption peaks of IM comparing the IR spectra at 3413 (aromatic C–H stretching), 2618 (carboxylic acid stretching), 1695 (C=O stretching), 1600 (C=C stretching), 1452 (O–CH3 deformation), and 1236 cm−1 (O–H deformation) were not altered after successful encapsulation of drug, indicating no chemical interactions between the drug and CA used. A comparison and an interpretation of this region in our spectra agree with their conclusions [14, 18].

Bottom Line: DSC, FTIR spectroscopy and stability studies indicated that the drug after encapsulation with fat microspheres was stable and compatible.Both formulations were found to be bioequivalent as evidenced by in vivo studies.Based on this study, it can be concluded that cetyl alcohol microspheres and Microcid SR capsule are bioequivalent in terms of the rate and extent of absorption.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagar, Karnataka, Mysore 570015, India.

ABSTRACT
The purpose of the present study was to compare the in vitro release and to find out whether the bioavailability of a 75 mg indomethacin capsule (Microcid SR) was equivalent to optimized formulation (indomethacin-loaded cetyl alcohol microspheres). Indomethacin-loaded cetyl alcohol microspheres were prepared by meltable emulsified cooling-induced technique. Surface morphology of microspheres has been evaluated using scanning electron microscopy. A single dose, randomized, complete cross over study of IM microspheres was carried out on 10 healthy male and female Albino sheep's under fasting conditions. The plasma was separated and the concentrations of the drug were determined by HPLC-UV method. Plasma indomethacin concentrations and other pharmacokinetic parameters obtained were statistically analyzed. The SEM images revealed the spherical shape of fat microspheres, and more than 98.0% of the isolated microspheres were in the size range 12-32 μm. DSC, FTIR spectroscopy and stability studies indicated that the drug after encapsulation with fat microspheres was stable and compatible. Both formulations were found to be bioequivalent as evidenced by in vivo studies. Based on this study, it can be concluded that cetyl alcohol microspheres and Microcid SR capsule are bioequivalent in terms of the rate and extent of absorption.

No MeSH data available.


Related in: MedlinePlus