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.2021 Jun;11(3):944-955.
doi: 10.1007/s13346-020-00804-6.

Characterisation of rectal amoxicillin (RAMOX) for the treatment of pneumonia in children

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Characterisation of rectal amoxicillin (RAMOX) for the treatment of pneumonia in children

Sara M Hanning et al. Drug Deliv Transl Res.2021 Jun.

Abstract

Access to medicines, including their availability and affordability, is a major public health challenge worldwide. This research aimed to characterise rectal formulations containing amoxicillin for the treatment of pneumonia in children under five, as an accessible alternative to existing formulations. Lipophilic Suppocire (S-NA15) and hydrophilic polyethylene glycol (PEG; 80% PEG 1500 and 20% PEG 4000, w/w) suppositories containing 250 mg amoxicillin were prepared. Hardness, apparent viscosity, uniformity of mass, uniformity of content, disintegration and dissolution time were determined. Irritation potential was screened using a slug mucosal assay and antibacterial efficacy against Staphylococcus aureus determined by isothermal microcalorimetry. Both lipophilic and hydrophilic formulations met the European Pharmacopoeia standards for suppositories when tested in vitro. They disintegrated within 30 min with rapid amoxicillin release profiles (98.6 ± 0.9%, 94.9 ± 1.2% over 30 min, respectively). Over-encapsulation of S-NA15 suppositories with hydroxypropyl methylcellulose shells slowed drug release and improved stability over 2 months. S-NA15 suppositories were classified as non-irritant and PEG suppositories only mildly irritant. Antibacterial efficacy of formulations was equivalent to amoxicillin alone. Both PEG and over-encapsulated S-NA15 rectal formulations developed in the present work have shown promise based on pre-clinical screening, and further development is justified to develop a product with commercial potential.

Keywords: Amoxicillin; Formulation; Paediatric; Rectal drug delivery; Suppository.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Visual representation of the modified disintegration test set-up, where the unit containing the suppository and 3-mL media was placed in a 37 °C water bath
Fig. 2
Fig. 2
Apparent viscosity (n = 3; mean ± SD) as a function of shear rate fora lipophilic suppositories at 37 °C comprising S-NA15 base (green diamond) or S-NA15 base in an HPMC capsule (dark blue square),b PEG suppositories melted at 70 °C (red circle) or dissolved in 3 mL water (light blue triangle). Filled symbols denote suppositories medicated with 250 mg amoxicillin; unfilled symbols denote unmedicated (blank) suppositories
Fig. 3
Fig. 3
Drug release profile (mean ± SD;n = 3) of amoxicillin from S-NA15 suppositories (green diamond), PEG suppositories (red circle), S-NA15OEC (S-NA15 suppositories over-encapsulated with HPMC shells) (dark blue square), commercial amoxicillin oral capsules (dotted line)
Fig. 4
Fig. 4
Calorimetric trace ofS. aureus in nutrient broth in the presence ofa S-NA15 suppositories andb PEG suppositories, showing power (mW) as a function of time for the blank control (black), amoxTH (red) blank suppositories (blue) and suppositories medicated with amoxTH (green)
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