Pharmacokinetics and clinical utility of Azunol-S tablet (AZ-S tablet: water-soluble Azunol 5mg) were studied.
Pharmacokinetics:
After an Azunol-S tablet was inserted into the labiogingival region of the upper jaw (A) or placed on the tongue (B) in healthy males, the concentration of water-soluble Azunol in saliva was determined.
1) While water-soluble Azunol in saliva remained at a constant level about 90 minutes after administration in case of A, it showed a high level soon after administration and disappeared after 15 minutes in case of B.
2) The volume of saliva in B was larger than in A and the saliva secretion was not influenced in A.
3) The dissolution time was about 90 minutes in A and about 10 minutes in B. Clinical Study:
An Azunol-S tablet was inserted into the labiogingival of the upper jaw of patients having mucosal inflammations of the oral cavity, tonsil, pharynx etc., or having undergone a minor operation for the oral cavity and pharynx at a dose of 1 tablet 4 times daily for 7 days.
1) The total number of patients was 146; pharyngitis 47, stomatitis 35, glossitis 24, tonsilitis 21, gingivitis 8, post-operation for the oral cavity and pharynx 11. Effectiveness (excellent and good responses) was observed in 63.8%, 74.3%, 70.8%, 52.4%, 100% and 54.5%, respectively.
2) In acute cases, effectiveness (excellent and good responses) was observed in 92.3% of glossitis, 83.3% of stomatitis and 62.5% of both pharyngitis and tonsilits. In chronic cases, effectiveness was observed in 66.7% of pharyngitis, 54.5% of stomatitis and 45.5% of glossitis.
3) Spontaneous pain, swallow pain, strange feeling, redness and swelling were greatly improved in acute pharyngitis, and strange feeling and redness were greatly improved in chronic pharyngitis.
4) Strange feeling, redness, swelling, ulcer or erosion, and stinging pain were highly improved in acute stomatitis, and spontaneous pain, strange feeling, redness and swelling were improved in chronic stomatitis.
5) When patients were asked about their feeling for the administration method, most of them answered “good” or “not nervous about it though aware of it”.
6) As to the side effects, 3 out of 146 patients complained of systemic symptoms, but it cannot be concluded that they were attributed to the drug. No local side effects in the oral cavity were reported, and no abnormal laboratory findings were observed. AZ-S tablet is regarded as safe and effective in mucosal inflammations of the oral cavity, tonsil, pharynx or post-operation for the oral cavity and pharynx.
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