Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Sep 1;18(4):498-509.
doi: 10.4274/tjps.galenos.2020.03443.

Formulation and Evaluation of Enteric Coated Elementary Osmotic Tablets of Aceclofenac

Shankhadip Nandi  1 , Ayan Banerjee  2 , Khandekar Hussan Reza  2
Affiliations

Formulation and Evaluation of Enteric Coated Elementary Osmotic Tablets of Aceclofenac

Shankhadip Nandi et al. Turk J Pharm Sci. .

Abstract

Objectives: This study aimed to develop a controlled drug delivery device for aceclofenac, a non-steroidal anti-inflammatory drug. Therefore, the agent was projected to develop an osmotic pump with enteric coating. The strength of the semipermeable membrane was improved by optimizing the formulation of the device, which can control the drug release over a prolonged period of time.

Materials and methods: The formulations were designed and optimized by using the statistical design of experiment followed by 32 factorial design to discover the best formulation. Several evaluation tests were performed to assess the physical parameters of the formulations. The percentage drug release of the formulations was observed for up to 9 h.

Results: The model 3D graph analysis indicated that as an osmogen, a higher percentage of potassium chloride was utilized more effectively than mannitol for the rapid dissolution of osmotic tablets. The optimized formulation can release 88.60±0.02% up to 9 h. The accelerated stability study confirmed that the optimized formulation was stable.

Conclusion: The formulated osmotic tablets of aceclofenac were therapeutically safe and effective and did not release any drug content in the simulated gastric medium for a predetermined time.

Keywords: 32 factorial design; 3D graph analysis; Statistical design of experiment; osmotic tablet.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: No conflict of interest was declared by the authors. The authors are solely responsible for the content and writing of this paper.

Figures

Figure 1
Figure 1
FT-IR spectrum of aceclofenac FT-IR: Fourier transform infrared spectroscopy
Figure 2
Figure 2
FT-IR spectrum of aceclofenac along with all excipients used FT-IR: Fourier transform infrared spectroscopy
Figure 3
Figure 3
In vitro drug release study of osmotic tablets (F1-F3)
Figure 4
Figure 4
In vitro drug release study of osmotic tablets (F4-F6)
Figure 5
Figure 5
In vitro drug release study of osmotic tablets (F7-F9)
Figure 6
Figure 6
Model 3D graph analysis
Figure 7
Figure 7
Contour plot analysis
Figure 8
Figure 8
Optimized formulation with maximum desirability and design points
Figure 9
Figure 9
Fitting in vitro drug release data of optimized formulation (F4) in different release kinetics models
Figure 10
Figure 10
Comparison of drug release between optimized and marketed formulation
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Mothilal M, Swati PS, Nelofar S, Damodharan N, Manimaran V, Lakshmi KS. Formulation and evaluation of aceclofenac compression coated tablets for colon drug delivery. Res J Pharm Biol Chem Sci. 2012;3:1062–1071.
    1. Roco MC, Bainbridge WS. Societal implications of nanoscience and nanotechnology: maximizing human benefit. J Nanoparticle Res. 2005;7:1–13.
    1. Ahuja N, Kumar V, Rathee P. Osmotic-controlled release oral delivery system: An advanced oral delivery form. Pharm Innov. 2012;1:116–124.
    1. Rathore GS, Gupta RN. Formulation development and evaluation of controlled porosity osmotic pump delivery system for oral delivery of atenolol. Asian J Pharm. 2012;6:151–160.
    1. Dasankoppa FS, Ningangowdar M, Sholapur H. Formulation and evaluation of controlled porosity osmotic pump for oral delivery of ketorolac. J Basic Clin Pharm. 2012;4:2–9. - PMC - PubMed

LinkOut - more resources