Ferrous Ascorbate 100mg, Folic acid 1.5mg & Zinc 22.5mg Tablet Multi-component solid oral formulation, consisting of an iron containing excipient, zinc and folic acid in specified quantities. Formulation: Considerations related to raw-material specifications, dispensing, ingredient interactions, mixing, compression and finished-product specifications are of utmost importance. This formulation can be added to a PCDF Pharma Franchise Range of Nutritional/ Mineral Tablets as part of a predefined range for pharmaceutical manufacturing specifications, quality control and packaging standards.
The formula has a Ferrous Ascorbate 100mg, Folic Acid 1.5mg, and Zinc 22.5 mg. The physicochemical properties of each ingredient can vary, so the initial phase of formulation development includes analysis of particle size, bulk density, flowability, moisture characteristics and compatibility with the envisaged excipient matrix.
The differential quantities of ingredient can be a significant factor during product development. Ferrous Ascorbate and Zinc are included at a higher level, whereas Folic Acid is included at a lower level. The formulation will need to be processed by a mixing method that is able to be uniformly dispersed with all three ingredients.
For approved products, excipients may consist of diluents, binders, disintegrants, glidants, lubricants and other functionalities. They are chosen based on the technical function to be performed and their compatibility with the active ingredients.
Pre formulation studies may also be performed to test the properties of powders, compatibility with excipients, hygroscopic nature and compression behavior before deciding on the commercial formulation.
The manufacturing process commences with the receipt of the raw materials, which include ferrous ascorbate, Zinc, Folic Acid and approved other ingredients, the specific receiving, labeling, testing and dispensing of these ingredients. All ingredients are weighed on the weight of batch manufacturing formula.
The lower amount of Folic Acid calls for specific attention to be paid during its dumping and blending. Controlled premix or geometric dilution procedures should be implemented if suitable to ensure the even distribution of the Folic Acid throughout the bulk powder.
Depending on their defined requirements, raw materials could be sieved, milled or otherwise preprocessed to meet the specifications. Particle size uniformity can affect flow properties and minimize segregation occurring when materials are conveyed.
Addition Order The sequence in which ingredients are fed to the mixer may affect the consistency of blending. Mixing parameters, including loading level, blending time, blending speed and addition order are set in formulation development.
Samples can be removed at designated points in the blend for testing samples of the final blend are accurately transferred to the compression area to prevent alterations in the composition.
The mixture can be further processed by direct compression or appropriate granulation method, depending on the physical properties. If granulation process is chosen, it includes binder slurry addition, granule formation, drying and screening, and final lubrication of granules.
Moisture content is checked as changes can affect powder flow, grain strength, compression characteristics and stability of some components of the formulation. The final blend is checked for flow and compressibility prior to compression into tablets.
Under compression, machine speed, compression force, feeder settings, and tooling arrangement are maintained as per defined process parameters. Checks on the process may include tablet weight, thickness, friability, appearance, hardness, and so on.
The formulation can be prepared as uncoated or film-coated tablets (depending on product design approved). When film coating is used there are likely to be significant spray rate, characteristics of the coating solution/suspension, pan rpm, inlet temperature and airflow, drying, and coating weight gain specifications.
Consistent compression conditions in process ensure consistent size and strength of tablets during a batch run.
Product Details Ferrous Ascorbate 100mg, Folic Acid 1.5mg & Zinc 22.5mg Tablets Quality control: – The analysis of each individual component of the formulation and the test of the physical characteristics of the finished tablets.
Test by Identification and assay using appropriate analytical methods that are suitable for the Ferrous Ascorbate, Folic Acid, and Zinc. The analytical procedure used must take into consideration the different chemical natures of the substances and should prove specificity and sensitivity.
The dosage-unit uniformity is an attribute of quality of the combination tablet. The proper sampling and testing of the dosage units demonstrate that each tablet contains the specified amount within an acceptable range.
Zinc content can be determined by an elemental or chemical analysis method appropriate to the nature of the test substance and the formulation, and Folic Acid by an appropriate method. Ferrous Ascorbate can be determined using an appropriate validated method.
Other finished-product tests can be carried out on the product such as a disintegration or dissolution, hardness, friability, weight variation, thickness, moisture content and physical appearance in accordance with the product specification.
All laboratory instrumentation must be appropriately qualified and maintained. Analytical procedures must be qualified or validated for the intended purpose and full records of the tests must be kept in the batch-release documentation.
Stability assessment The stability assessment establishes whether the said quality attributes of Ferrous Ascorbate 100mg, Folic Acid 1.5mg & Zinc 22.5mg Tablets are maintained throughout the recommended shelf life. Testing parameters that may be studied include assay, impurity/degradation products, physical form, dissolutions/disintegrations, moisture parameters and others.
The formulation might need testing under specified temperature and humidity conditions to ascertain long term and accelerated storage conditions.
Packaging choice may be determined by the stability profile of the formulation to be delivered and the level of protection from the environment required. Within the approved configuration of the product, pharmaceutical-grade blister packs or strips or other suitable container systems may be employed.
In-vitro release method2 Also, packaging compatibility studies can be performed to evaluate interaction of the tablets with the packaging material. Seal-integrity test can be performed to evaluate protection against environment.
The finished pack should be easily understandable with regard to the name of the product, composition, strength, batch identification, date of manufacture, dates of expiry, storage conditions and any other relevant regulatory specifications.
Correct packaging ensures the product maintains its integrity throughout transit, storage in the warehouse and as it is handled along the distribution chain.
Ferrous Ascorbate 100mg, Folic Acid 1.5mg & Zinc 22.5mg Tablets can be added to a wider range of pharma and nutrition products by following standardized formulation techniques and producing in a regulated environment. Companies in the PCD Pharma Franchise range may find it helpful to set clear technical documentation for the product.
A structured product file may consist of raw-material specifications, supplier qualification documents, formulation composition, master manufacturing instructions, analytical methods, finished-product specifications, packaging specifications, and stability-study records.
Attention to the homogeneity of Folic Acid is warranted given its relatively small amount in the total formulation. Rigorous premix control, proper blending technique, representative sampling, and validated analytical techniques can all contribute to more consistent dosage-unit quality.
Should be in-process quality control at all stages including the inspection of incoming raw material, dispensing, preprocessing, blending, compression, coating (if required), packaging and release of each batch. Each stage must be documented with appropriate in-process controls.
When dealing with the commercial portfolio, ensure the technical composition is consistent for product catalogs, packaging artwork, digital contents and all product information. Having the right product information supports the product and other information to follow the manufacturing criteria.
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