Ebook Production of Zinc Tablets and Zinc Oral Solutions
WHO and UNICEF have released revised recommendations for the management of diarrhoea aimed at dramatically reducing the number of deaths due to diarrhoea. These new recommendations take into account two significant recent advances: demonstration of the increased efficacy of a new formulation for ORS containing lower concentrations of glucose and salt, and success in using zinc supplementation in addition to rehydration therapy in the management of diarrhoeal diseases.
In order to ensure that these recommendations become effective, it is essential that the industry be encouraged to prepare zinc formulations which contain only zinc as active ingredient. Many vitamin products and other nutritional supplements containing zinc are available commercially. However, it is uncommon for these products to have the recommended dosage of zinc. Therefore a product containing only zinc is required. The product should be formulated in such a way as to mask the strong metallic aftertaste of zinc to enhance acceptability to children. Zinc salt formulations for administration to children could take the form of oral solution or tablets. The specifications of zinc products for use in the management of diarrhoea are listed in Annex 1.
For all organizations involved in the procurement of zinc tablets or zinc oral solutions, the procurement should be made from trusted sources, such as those companies pre-qualified for zinc tablets and oral solutions in the UNICEF suppliers list and those with a proven record of quality products. When organizations make a tender to purchase zinc products, the tender should clearly state the quality specifications required as mentioned in Annex 1. In addition, zinc sulfate tablets and zinc sulfate oral solutions should comply with the specifications as detailed in the relevant pharmacopoeial monographs for zinc sulfate tablets and/or zinc sulfate oral solution (see USP monographs in Annexes 2 and 3). Relevant monographs on zinc sulfate tablets and zinc sulfate oral solutions are also under development for inclusion in the International Pharmacopoeia.
These guidelines were prepared to assist policy makers and programme managers in the selection and procurement of quality zinc products (zinc tablets and zinc oral solutions) for use in the prevention and treatment of diarrhoea in children under the age of five. These guidelines can also be used by pharmaceutical manufacturers to develop quality zinc products.
contents
1. Introduction
2. Specifications common to tablets and oral solutions
2.1 Ingredients and process
- 2.1.1 Starting materials
2.1.2 Zinc
2.1.3 Sweetening and flavouring agents
2.2 Strength
2.3 Identification
- 2.3.1 Solutions
2.3.2 Identification tests
2.4 Assay
- 2.4.1 Assay for tablets
2.4.2 Assay for oral solutions
2.5 Packaging and storage
2.6 Labelling
3. Additional specifications for zinc tablets
3.1 Dispersibility of zinc tablets
3.2 Uniformity of content
4. Additional specifications for zinc oral solutions
4.1 pH
4.2 Specific gravity
5. Acceptability of zinc tablet and zinc oral solutions
5.1 Evaluation of taste masking
5.2 Evaluation of acceptability and adherence to treatment
6. Other considerations
6.1 Product formulation and production
6.2 Product registration
6.3 Inclusion of zinc in the National Essential Medicines List
6.4 Postmarketing surveillance and adverse drug reaction (ADR) monitoring
- 6.4.1 Adverse drug reactions
6.4.2 Reporting of adverse drug reactions
6.5 Quality assurance for the procurement of zinc tablets and oral solutions
ANNEX 1: Specifications of zinc products for use in the management of diarrhoea
ANNEX 2: USP monograph for zinc sulfate tablets
ANNEX 3: USP monograph for zinc sulfate oral solution
ANNEX 4: Disintegration
ANNEX 5: pH
ANNEX 6: Specific gravity
ANNEX 7: Qualitative evaluation of the taste by a taste panel
ANNEX 8: Design of the acceptability study
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