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The azithromycin solution stability was better at basic than neutral pH. Azithromycin content Fig. The relative stability and apparent solubility performances of azithromycin were deemed compatible with rectal administration. Several pharmaceutical forms, namely rectal gels, hard gelatin capsules and suppositories, were developed for the purpose Table 1.
The spectrum of pharmaceutical forms was restricted by our target product profile, to opt that it would be inexpensive, could withstand tropical conditions, is easy to use by children and delivered by untrained persons. Thus, novel technologies, e.
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A series of assays was performed to ensure the feasibility and obtain correct pharmaco-technical performances. A muco-adhesive gel was tested in order to enhance rectal bioavailability by increasing the residence time in situ as compared to classical non muco-adhesive formulations. The content of the gelling agent carbopol 0. Soluble suppositories, based on PEG mixtures, were preferred to fatty fusible suppositories as they have a higher melting point, thus not requiring special storage conditions.
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Previous studies showed that the melting point increases and drug release rate decreases with increasing PEG molecular weight Leuner and Dressman, The HGC formulation was modified in terms of flowability of the powder mixture and in terms of homogeneity of the mixing process by adding a colouring agent in feasibility batches.
Colloidal silica improved the flowability whereas talc and magnesium stearate did not. The minimal quantity of colloidal silica obtaining satisfactory flowability results was chosen for further evaluations. Final formulations are summarized in Table 1. The drug is released from PEG suppositories as a consequence of the progressive dissolution of PEG in the surrounding liquid. PEGs are known to increase both, drug dissolution and its solubility, explaining enhanced drug release Allen, Drug release studies of gels and oily suspension of azithromycin, contrary to HCG and suppositories, required the use of dialysis bags, making results not directly comparable.
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Overall, the rate of drug release was low from gels viscosity reducing the dissolution rate and hampering the diffusion of dissolved azithromycin fractions towards dissolution medium and oily suspension indirect mechanism of release: dissolution in oily phase, diffusion towards interface, partition between aqueous and oily medium Table 2.
The long term ICH stability studies were outside the scope of our preliminary project, and are planned only for the final, biopharmaceutically optimized formulation. Nevertheless, suppositories and hard gelatine capsules were kept in ambient condition in plastic moulds or closed glass bottle respectively. Samples were periodically analysed by HPLC for their drug content. In view of in vitro and in vivo drug release data, gel's stability was not analysed further.
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Doses were determined based on previously published animal pharmacokinetic data Shepard and Falkner, These results are in line with in vitro dissolution data. Of the formulations tested, the PEG suppository appears to be the most promising candidate, but has a potential shortcoming — the rather long T max , which is of particular concern if early onset of action is needed.
The suspended PEG suppository is a prototype and will require further, biopharmaceutical optimization work. The bioavailability of the suppository formulation could be further improved by adding absorption enhancers or using a eutectic mixture of PEG and azithromycin. The principles used to improve drug solubility for oral delivery Shepard and Falkner, could be applied to rectal formulations. Even though rectal tolerance studies were beyond the scope of the current screening work, no significant change in rabbit behaviour was evidenced that could be ascribed to tolerability issues, nor was the presence of blood at the anal sphincter with any of the formulations.
The effect of azithromycin dose on exposure is reported in Table 4.
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Pharmacokinetic parameters did not vary proportionally with the dose of azithromycin administered. T max remained unchanged. Again, caution should be applied when interpreting these results, both because of the small number of experimental animals and because plasma concentrations may not reflect the true total exposure in peripheral compartments.
Future studies with improved formulations should allow extended sampling time and ideally measure tissue levels as well as plasma concentrations. An azithromycin suspended PEG suppository was identified as a promising candidate for further pharmaceutical development with the aim of achieving comparable bioavailability to the oral route. Such formulation would be an easy-to-use, safe and cheap alternative to oral and injectable forms. While the reason for developing a rectal form was primarily intended for near-home emergency use in rural settings of developing countries, a PEG suppository of a broad-spectrum antibiotic would also be a useful addition to the current paediatric therapeutic armory.
The authors wish to thank Mrs. Anne-Marie Lagueny and Ms. Muriel Manse University of Bordeaux Segalen, France for their technical support during laboratory development of formulations and Dr. Paolo Colombo Accelera Srl, Italy for his expertise for animal experimentation. Olliaro is a staff member of the WHO; the authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy or views of the WHO.
National Center for Biotechnology Information , U. Sponsored Document from. International Journal of Pharmaceutics. Int J Pharm. White , e, f Piero L.