Abstract
Solvent cast mucosal films with improved drug loading have been developed by combining carboxymethyl cellulose (CMC), sodium alginate (SA), and carrageenan (CAR) using paracetamol and amoxicillin as model drugs and glycerol (GLY) as plasticizer. Films were characterized using X-ray powder diffraction (XRPD), scanning electron microscopy (SEM), folding resilience, swelling capacity, mucoadhesivity, and drug dissolution studies. SA, CMC, and GLY (5 : 3 : 6) films showed maximum amoxicillin loading of 26.3% whilst CAR, CMC, and GLY (1 : 2 : 3) films had a maximum paracetamol loading of 40%. XRPD analysis showed different physical forms of the drugs depending on the amount loaded. Films containing 29.4% paracetamol and 26.3% amoxicillin showed molecular dispersion of the drugs while excess paracetamol was observed on the film surface when the maximum 40% was loaded. Work of adhesion was similar for blank films with slightly higher cohesiveness for CAR and CMC based films, but the differences were significant between paracetamol and amoxicillin containing films. The stickiness and cohesiveness for drug loaded films were generally similar with no significant differences. The maximum percentage cumulative drug release was 84.65% and 70.59% for paracetamol and amoxicillin, respectively, with anomalous case two transport mechanism involving both drug diffusion and polymer erosion.
Highlights
The most widely used and preferred route of drug administration is the oral route, providing both safety and patient compliance [1, 2]
GLY was chosen as plasticiser as it has been shown previously to be a suitable plasticiser for hydrophilic polymers such as carboxymethyl cellulose (CMC) and sodium alginate (SA) [18]
For gels prepared by the first approach described earlier, the drug precipitated by recrystallisation during the film drying process as water evaporated from the gel
Summary
The most widely used and preferred route of drug administration is the oral route, providing both safety and patient compliance [1, 2]. Films are popular amongst patients having difficulty swallowing tablets and capsules (dysphagic patients) This is because the strips readily hydrate in the moist buccal cavity enabling the dosage form to be administered at any geographical location and any time depending on the convenience of the individual without the need for clean water [12, 13]. Factors governing the extent of drug absorbed from the mucosal surface include the concentration the active ingredient, the vehicle used for its delivery, contact time with the mucosal surface, venous drainage of the mucosal tissues, degree of ionization of the drug, pH at the site of absorption, and relative lipid solubility of the drug [14]. The aim is to increase the drug loading capacity of two model water soluble drugs, paracetamol and amoxicillin, which are normally loaded into tablets or capsules in relatively high amounts (500 and 250 mg per dose, resp.) and well characterised in terms of physical and chemical properties
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