Ferrous Ascorbate 100mg, Folic Acid 1.5mg & Zinc 22.5mg Tablets Ferrous Ascorbate 100mg, Folic Acid 1.5mg & Zinc 22.5mg Tablets are a multi-nutrient combination solid oral dosage form, comprising three active ingredients in precisely controlled amounts. The formulation brings together three nutritional components (Ferrous Ascorbate 100mg, Folic Acid 1.5mg, and Zinc 22.5mg) into a single dosage form, encapsulated within a suitably designed tablet matrix. Development of such multiple ingredient combination products involves selection and sourcing of ingredients, dispensing verification, compatible blending, excipient selection, product compression optimization, and detailed quality control testing to verify the quality of the finished medicine. This formulation can be added to a pharmaceutical company's nutritional franchise portfolio, supported by technically detailed specifications and manufacturer's documentation using a professional PCD Pharma Franchise management system.
The formulation combines three ingredients, which will have separate or combined physical and chemical properties to consider during preparation. The properties of the active ingredients, when stored and in combination, can include particular particle sizes, densities, flow properties, moisture absorption or loss, compression potential, and compatibility with other excipients selected.
Ferrous Ascorbate (100mg), Zinc (22.5 mg), and Folic Acid (1.5 mg) components in a formulation of this type can be supplied in bulk in different quantities. The development of the product formulation will take account of the significant amount of difference in the component active ingredient quantities. This can be important for ensuring correct premixing of the selected lower-quantity components. The premix may be tested for uniformity according to acceptable procedures.
A wide range of diluents, binders, disintegrants, lubricants, glidants, or other excipients may be used to optimize the manufacturing process, according to the intended process (direct compression or granulation) and the tablet's physical properties. Compatibility testing between active ingredients and excipients can be performed to ensure the selected formulation can be manufactured consistently.
Preparation of the total powder mix for this formulation will include accurate weighing and recording of each ingredient in accordance with the registered formula and approval conditions. The low-quantity Folic Acid material may require premixing with a portion of the selected excipient mixture using geometric or other mixing arrangements prior to blending with the rest of the active ingredients.
The bulk powders are sieved or milled to create the required particle size distribution. The premix for each component material can be prepared as required prior to blending. During this stage, the overall uniformity of the blend is checked in accordance with approved sampling plans.
The total blend can be prepared in a controlled process of mixing, where the time, direction of mixing, order of addition, time of mixing, and other factors can be set to provide a consistent finished blend. The blend can be tested from specified positions for uniformity of composition prior to compression.
The formulation can be compressed directly or use granulation to create the final blend for compression into tablets. The speed of compression, compression force, and any other relevant parameters in the compression process can be controlled, monitored, and recorded to minimize variation of individual tablet strength or size. The blend received at the tablet press can be assessed visually, for uniformity and for other physical parameters such as tablet hardness or disintegration.
Manufacture of coated or uncoated (plain) tablets may be carried out in accordance with the product requirements. For coated products, coating can be applied to provide a suitable coating weight and rate within acceptable range and in accordance with the approved method and formulation specifications.
During compression, the tablet weights, disintegration time, physical appearance, hardness, weight variation, and other characteristics of the product can be checked as part of the process control strategy.
Finished product quality control testing of each active component in the finished formulation can be undertaken with validated testing methods to identity or determine dosage content and assay quality. Sample tablets can be tested and compared against target ranges, to reflect approved standards.
The full specification for the finished product should allow appropriate analytical testing for the ability to correctly measure each ingredient from the finished product. Identification testing and assay testing for each component, and other acceptable parameters, can be performed at the end of the process to ensure the product conforms to specifications.
The content of Ferrous Ascorbate, Folic Acid, and Zinc in the finished tablet can be assessed by an appropriate validated technique in accordance with the published international method. Other finished product tests can include disintegration, dissolution or disintegration time, hardness, friability, and product appearance as required.
The finished test samples should include not only the active component assay test items, but also the routine control items with complete documentation of raw data and calculations.
Stability testing of the finished product can include analysis of stability for the assay of active components, physical and visual appearance, disintegration or dissolution characteristics, and appearance characteristics. The stability tests can be undertaken following long-term stability and accelerated stability regimes according to the approved stability program. Particular attention may be paid to the environment, where present, including the chemical stability of the content.
For finished product packaging, primary packs such as strips, blister packs, or other suitable packaging format can be tested for content protection and stability during storage. There can be a test for compatibility between the tablet and the primary packaging material, including testing of label adherence, quality, and integrity. Storage conditions can be defined for the pack, with protection against environmental factors.
The completed packs should be correctly labeled with all necessary product, batch, and storage details, including an expiration date, product name, and other local requirements.
The combination of active ingredients such as Ferrous Ascorbate (100mg), Folic Acid (1.5mg), and Zinc (22.5mg) in the formulation developed and optimized under controlled process conditions can be packaged into a tablet (or coated tablet) for distribution. The product should be monitored in accordance with the specifications provided, and the technical documentation and batch records maintained.
The portfolio of products of this type can be extended through a PCD Franchise management process that ensures label consistency, accuracy of presentation, and adherence to the portfolio branding. The functionality of a nutritional supplement or pharmaceutical product portfolio can be streamlined through the use of documented quality systems, batch management controls, and technical product specifications.
The pharmaceutical company's portfolio of products can include finished tablets, with detailed specifications for each component, finished product testing ranges, stability conditions, and labeling instructions. This allows the consistent production of the product on a commercial scale, with batches controlled and verified as recording to technical standards.
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