Development and functional characterization of composite freeze dried wafers for potential delivery of low dose aspirin for elderly people with dysphagia

Abstract

The impact of demographic ageing is likely to be of major significance in the coming decades due to low birth rates and higher life expectancy. Older people generally require more prescribed medicines due to the presence of multiple conditions such as dysphagia which can make swallowing medicines challenging. This study involves the development, characterization and optimization of composite wafers for potential oral and buccal delivery of low dose aspirin to prevent thrombosis in elderly patients with dysphagia. Blank (BLK) wafers (no loaded drug) were initially formulated by dissolving combinations of metolose (MET) with carrageenan (CAR) and MET with low molecular weight chitosan (CS) in different weight ratios in water, to identify optimum polymer combinations. However, drug loaded (DL) wafers were prepared using 45% v/v ethanol to help complete solubilization of the aspirin. The formulations were characterized using texture analyzer (hardness, mucoadhesion), scanning electron microscopy (SEM), X-ray diffractometry (XRD), attenuated total reflection-Fourier transform infrared (ATR-FTIR), differential scanning calorimetry (DSC), thermogravimetric analyzer (TGA), and swelling capacity. Wafers with higher total polymer concentration were more resistant to penetration (MET:CAR 1:1 samples B2, C2) and MET:CS 1:1 (sample E2) and MET:CS 3:1 (sample F2) and also depended on the ratios between the polymers used. From the characterization, samples C2, B2, E2 and F2 showed the most ideal characteristics. XRD showed that BLK wafers were amorphous, whilst the DL wafers were crystalline due to the presence of aspirin. SEM confirmed the presence of pores within the polymer matrix of the BLK wafers, whilst DL wafers showed a more compact polymeric matrix with aspirin dispersed over the surface. The DL wafers showed a good flexibility required for transportation and patient handling and showed higher swelling capacity and adhesion values with phosphate buffer saline (PBS) than with simulated saliva (SS). Drug dissolution studies showed that aspirin was rapidly released in the first 20 minutes and then continuously over 1 hour. FTIR confirmed the interaction of aspirin with the polymers evidenced by peak shifts around 1750 cm-1 and the broad peak between 2500 to3300 cm-1. Lyophilized CAR: CS 1:3 (sample DL13), MET:CS 1:3 (sample DL8) and MET:CAR 3:1 (sample DL1) wafers seem to be a very promising system for the administration of low dose aspirin for older patients with dysphagia.

Nanofibrous asymmetric collagen/curcumin membrane containing aspirin-loaded PLGA nanoparticles for guided bone regeneration

“…The appearance of diffraction two-theta (2θ) peaks at 7°, 15°, 20°, 22° and 27°, corresponding to the characteristic crystal form of aspirin as reported in the literature 48 . Aspirin-loaded PLGA nanoparticles showed all characteristic peaks of aspirin but appear less intense as compared to pure aspirin 48 which is due to the amorphous nature of the PLGA 49,50 . The XRD pattern of curcumin displayed sharp and intense peaks between 10° and 30°, representing a crystalline arrangement.…”

In vitro, ex vivo and in vivo evaluation of taste masked low dose acetylsalicylic acid loaded composite wafers as platforms for buccal administration in geriatric patients with dysphagia

“…The drug loaded (DL) wafers were prepared by freeze-drying solutions combining MET with CAR and MET with CS in different weight ratios with each final wafer containing 75 mg of acetylsalicylic acid as previously reported (Farias & Boateng, 2018) and subsequently taste masked using different ratios of sucralose (Suc), aspartame (Asp) and stevia (Stev) as summarized in (Table 1). Then 1 g was poured into each well of a 24 multiwell plate (diameter 15.5 mm) with 75 mg of acetylsalicylic acid per well.…”

“…The system was placed on a water bath at 37 °C and magnetically stirred (200 rpm). At predetermined time intervals, 0.5 ml aliquots (n = 3) of the SS were withdrawn, filtered through a 0.45 µm cellulose acetate membrane, and analyzed using HPLC by following the method previously reported (Farias & Boateng., 2018).…”

“…This is because of a loss of muscle strength in the mouth and throat regions, which makes it difficult for geriatric patients to chew. Further, these chewable tablets also show fragile (poor mechanical strength) and effervescent granular characteristics and therefore careful handling is required (Renu, et al, 2015;(Farias & Boateng., 2018)).…”

Swallowing Gel for Patients with Dysphagia: A Novel Application of Chitosan

“…Consequently, novel dosage forms designed for older adults and medical devices/tools have emerged in the last decades, such as oral disintegrating tablets [4,5], composite freeze dried wafers [6,7], spray solution for tablet/capsule film coating [8], and spray solution for oral cavity films [9]. Nonetheless, novel dosage forms can be time-consuming and expensive, and other swallowing aid innovations are inconvenient.…”