Formulation and evaluation of mucoadhesive buccal tablets of aceclofenac

Abstract

This project was aimed to formulate and characterize mucoadhesive buccal tablets of aceclofenac, utilizing different proportions of three polymers carbopol 934, hydroxypropyl methylcellulose, and sodium carboxymethylcellulose. Twelve batches of buccoadhesive aceclofenac were prepared by the direct compression method. The compressed tablets were then evaluated for physicochemical parameters such as hardness, thickness, weight variation, drug content, friability, swelling index, surface pH, and ex vivo mucoadhesion. In vitro dissolution test was conducted for 12 h according to Indian Pharmacopeia 2018, using the rotating paddle method in phosphate buffer of pH 7.4. Physiochemical parameters like weight variation (231.25-268.75 mg), hardness (8.32-11.56 kg), friability (0.04-0.2%), diameter (9.00 mm), thickness (3.8-4.05 mm), and drug content ((97.67-102.25%) were within the acceptable limit as per Indian Pharmacopeia 2018. The swelling index was reported to be in the range of 112.93-450.19%, at 8 h. The surface pHs of all the batches were in between 6.72 to 6.96. The mucoadhesive strengths (40.5-50 g) varied with the change in polymer concentrations especially of carbopol 934. The dissolution profile of all the batches varied greatly, with a maximum release of 109.41% (in batch 12 at 6 h) to a minimum release of 44.82% (in batch 3 at 12 h). Among them, only batch 1 ensured sustained and effective drug release (88.34% at 12 h) with appropriate swelling index (112.93%) and mucoadhesive strength (40 g). Fourier Transform Infrared Spectroscopy analysis showed no evidence of drug excipients interaction. Hence, the results concluded that buccal mucoadhesive aceclofenac tablets can be formulated. Furthermore, the property of the tablet not only depends on the concentration but also the behavior of the polymers used.

Keywords: Aceclofenac; Buccal tablets; Mucoadhesion; Swelling index.

Figure 1

General lay out of modified pan balance used for the determination of mucoadhesion force of newly formulated tablets [20].

Figure 2

HPLC Chromatogram of the standard and test sample (A: standard drug Aceclofenac, B: Batch sample).

Figure 3

HPLC chromatogram of the blank and placebo (C: Blank, D: Placebo).

Figure 4

Mucoadhesive strength of different batches calculated by using modified pan balance. Note: Different alphabet (a–h) indicate significance difference among the batches (p < 0.05).

Figure 5

Comparative study of swelling index for 12 batches of aceclofenac mucoadhesive tablets at different time intervals.

Figure 6

Dissolution profile of different batches of aeclofenac mucoadhesive tablets.

Figure 7

Chromatogram of FTIR for Aceclofenac (blue color: FTIR chromatogram of standard drug Aceclofenac, green color: FTIR chromatogram of the Aceclofenac mucoadhesive tablet containing HPMC, Carbopol 934, and Sodium CMC.