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/// Analysis of Dosage Forms


Analytical Testing is an important aspect rather more important than preparing a formulation. The design should fulfill the outcome of a product. A medicinal product in order to be released for clinical or commercial use and specification should b as per the compendia to ensure quality and efficacy of the medicinal product.

Since a pharmaceutical manufacturer is responsible for assuring the quality, identity, purity and strength of each batch of drug product manufactured, he has to ensure that batch conforms to specification when tested to the listed analytical methods, shall meet the acceptance criteria which in other words are known as quality standards.

Following tests may be performed: general quality attributes and product performance, for instance drug assay, viscosity microbial limits if desired by the manufacturer.

Universal tests of drug products, such as description, identification, assay and tests for presence of impurities may also be conducted. Analytical tests on sophisticated instruments like FTIR, UV, COMPATIBILITY WITH EXCIPIENTS, IMPURITIES, DEGRADATION PRODUCTS, MASS SPECTROSCOPY, HPLC, UHPLC, GC, LCMS ETC.

To determine the strength or content of the API in the dosage form a specific test is carried out which can give results in quantitative terms and if desired can detect chemical changes with respect to time.

ICH Guidelines Q6A defines an impurity in a drug product as any component that is not the API or an additive. They may be process impurities from the new drug substance synthesis, degradation product of API or both. This test may be a purity test and must be stability indicating. This may be performed as assay or can be developed differently for measuring low-level impurities.

The drug product assays can be performed to validate label claim of the product manufacturers.

Assay methods used are validated for SPECIFICITY, LINEARITY RANGE, ACCURACY, PRECISION, and ROBUSTNESS AND SAMPLE AND STANDARD STABILITY.

Product quality and performance tests for drug injection products are listed:
  • Identification
  • Assay
  • Impurities
  • pH
  • Particulate matter
  • Moisture content
  • Content uniformity
  • Endotoxin
  • Sterility
  • Reconstitution Time.
Oral Dosage forms:

Tests can be carried out on different types of oral dosage forms, such as, tablets, capsules, powders, granules, medicated gums, chewable tablets, lozenges, solutions, suspensions generally sold on prescription or as OTC products. Tests on oral tablet prescribes are as follows:
Appearance,
Identification
Assay
Impurities
Content uniformity
Dissolution
Moisture content
Tablet Breakin Force
Friability
Disintegration
X-Ray Diffraction
Microbial content

Micro-organisms presence or absence (specific) Tests on delayed release tablets, extended release tablets may also be carried out as per discretion of the manufacturer and his requirements.

Quality Assurance and Quality Control:

Our pursuit of quality approach is guidance through the application of quality systems including defect prevention and continuous improvement.

Our help shall be to those pharmaceutical manufacturers, both small and medium scale to educate and guide them about current Good Manufacturing Practices (cGMP) for finished dosage forms.

Our guidance will also include in operations like aseptic manufacturing, validation and stability testing as per 21CFR both for QC and QA departments of an industry to serve as the primary contact with regulatory agencies for product acceptance or rejection. SOPs shall be created accordingly. Internal standards should be adopted within the industry to meet quality requirements. Quality monitoring is another major function performed by QA team of the industry, so that standard manufacturing procedures are followed and are carried out by trained operators. This achieves compliance with regulatory bodies. Therefore prior to product failure a deficiency can be detected and necessary corrections are made.

Guidance about quality control begins with sampling and analytical testing of raw materials, investigation of packaging components including labeling. In-process testing such as environmental monitoring may also be guided. Evaluation of product stability may also be conducted. Often in-process action levels will be identified and set so that they will allow timely corrective action before out-of control situation occurs. Our Quality by design approach will identify parameters within which the process will perform satisfactorily.

We as part of quality control team will monitor environmental conditions under which parenteral and ophthalmic products must be produced in a controlled atmosphere. This is created to ensure their sterility. Monitoring and evaluation of environment in which liquids, tablets and capsules are manufactured may also be done which determines an acceptable level of particulates and microbial contaminants and control them to this level; thereby ensuring quality and stability of the final dosage forms.

Controls of packaging component specially which come in direct contact with a product is required. Rigid specifications are prescribed such as compatibility of the product with these materials, storage stability, leachability, and limits for extractives. Final product labeling must be 100% checked to ensure its correctness.

Quality must be developed into products, starting with R&D phases. Quality by Design (described by ICHQ8 (R2) guidance for industry) is of most importance in the development of product and processes. We have established product quality criteria and write detailed specification for dosage form manufactured. We can design facilities for construction of suitable plants to provide stable environment for protecting integrity of products. We may supervise selection of proper equipments. We shall be happy to train your personnel properly so that their job performance is equipped to satisfactory levels. We can carry out training programs for your team.

Document such as those found in the product development phase, those associated with actual manufacturing and testing of individual batches shall be developed in the form of

  • Research & Development reports
  • Technology Transfer reports
  • Non-clinical and Clinical study reports
  • Validation records.

There are unique quality checks on the products obtained in the field of pharmaceutical biotechnology due to complex physical and chemical nature of protein products. Therefore all phases like early R&D, synthesis, product scale-up and commercial manufacture is associated with rigid quality specifications. There is a big difference between biologics and chemical drug products. They may be macromolecules frequently thermo labile, consisting of complex mixtures of proteins with other molecules and lastly are highly susceptible to microbial contamination.

The attributes possessed by them shall be investigated, they are: sterility, absence of pyrogens unwanted organisms by products and degradation by-products. cGMP requirements prevail here also. Their full characterization includes their physical and chemical stability.


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