In view of the requirements of the WHO guidance document, Production of Zinc Tablets and Zinc Oral Solutions: Guidelines for Programme Managers and Pharmaceutical Manufacturers, the following are preferable for the PQP:
- Treatment is recommended as 10 or 20mg as a single dose and procurers are encouraged to purchase either the 10 mg or 20 mg tablet strength, not both. Therefore, it is expected that any tablet formulation containing 20 mg elemental zinc per tablet should be scored to facilitate breaking. A demonstration of the weight uniformity of tablet halves is required for scored tablets. The Applicant should carry out a subdivision test as per Section 3.2.P.2.2.1 of the WHO PQP quality guideline to demonstrate that the tablets can be divided into equal halves.
- Specifications should be in line with the Ph.Int. monographs for Paediatric Zinc Sulfate Oral Solution and Paediatric Zinc Sulfate Tablets as appropriate.
- Additional specifications should include fineness of dispersion and uniformity of dosage units for tablets. Oral solutions should include visual inspection (clear and free from any precipitate). See also the notes on disintegration in this document.
- Evaluation of taste masking or taste acceptability for both formulations should be conducted during product development.