ABOUT AUTHOR
Soumyanath Mishra
Head & DGM, Packaging Development-F&D
Mankind Research Centre
soumyanath.mishra@mankindpharma.com
Packaging is an important component in the development of various drug formulations in pharmaceutical industry. Packaging of pharmaceutical dosage forms has a close relationship between a pharmaceutical preparation and its package which is a major concern to the drug stability and safety. The selection of Packaging material is made on the basis of its efficacy and performance characteristics in preserving the quality, potency and safety of the pharmaceutical products. The stability testing of pharmaceutical products and compatibility testing of packaging materials is an integral part of R&D in pharmaceutical industry. The stability of a drug in solid and liquid dosage forms depends on the efficacy of the packaging materials to protect the drug from chemical degradation and changes in physical characteristics such as appearance, hardness, friability, dissolution, disintegration, weight variation, moisture contents and mechanical durability.
This is particularly necessary for the storage of the products under accelerated conditions. It has been observed that due to lack of packaging professional and the use of substandard packaging materials by some pharmaceutical industries leads to stability problems, packaging materials - drug interaction, poor efficacy to moisture barrier and formation of hazardous materials. In order to study the effect of environmental factors on the packaging efficacy of solid and liquid dosage form preparations, it is intended to study the stability of a number of selected pharmaceutical products in packaging materials using glass, aluminum foil, plastic, paper and other materials as primary or secondary packaging material and to determine the extent to which these materials are effective in providing protection to the product and in maintaining its desirable physical and chemical characteristics under the proposed storage conditions. That is why we need good packaging technologist in R&D to make them understand . It is intended to evaluate the shelf lives of the products stored in different packaging materials and examine their efficacy and performance characteristics in maintaining the product integrity for a prolonged period of storage
Often this seems to not be included or considered in the development of the product, and how packaging help with patient compliance, patient safety or increased stability and shelf life. The roll of the packaging is consider to only contain the product in formulation R&D. But many cases, it has been established that where with best formulation , the drug products are not stable and due to the limitation of formulation and that formula is well stabilized with innovative packaging solution. It is only possible with good collaboration with formulation scientist and packaging scientist in R&D.
Few common but major issues like delamination of glass, pH Shifting, significant assay lost or may be increase of impurities in the drug product. It has very well solved in coordination with R&D Packaging development.
For an example : It often seen that generic companies are follow the innovator or reference packaging but Generic drug product formulation team need to think importance of packaging at the earlier stage of development so to develop right packaging for their product. This is because although the name of the drug product is same but there are many difference like
1.Source of the active pharmaceutical ingredient is different from innovator .
2. Source of the excipient is different from innovator
3.Quantitative proportion is different both active pharmaceutical ingredient and excipient.
4. Drug manufacturing process and parameters are different . May be due the Patent and exclusivity .
But as per the FDA, the drug product should bio equivalence with the innovator but that does not mean the stability with so called change formula should be same with innovator packaging so there are very critical role of packaging scientist to select correct packaging materials so that the new formula should be stable in selected packaging and off course complying the FDA requirement.
Changes in pharmaceutical industry research and manufacturing technologies have driven significant developments in packaging and delivery systems. An increase in the number of large-molecule, biopharmaceutical drugs in development pipelines has led to an increase in the need for injectable packaging and administration systems. The old glass and elastomer closure systems may not provide the effective barrier properties needed for high-value, lifesaving therapies. Packaging and delivery systems are more demanding aspect for drug products. For an example A pharmaceutical company needs a prefillable system that protects the integrity of the packaged drug product over time and will function as represented over the full shelf life of the drug product. The role of packaging is very important to select suitable optimum packaging.
The above part it is discussed with more about safety and stability of the drug product but efficacy and safety are no longer sufficient for new medications reaching the market today. Evidence-based medicine (EBM), comparative effectiveness research (CER), patient-centric packaging (PCP) and value-based pricing are becoming key concepts in the pharmaceutical industry. New drugs must provide measurable value not only to patients, but to other stakeholders.
Today Industry trends are driving the use of innovative packaging solutions which should be cost effective so role of packaging is very import at the time initial drug development stage so that it will create any surprise at the time of commercialization of the drug.
There has been more consideration in recent years to safeguard transporting drugs (cold chain, drop tests and the like) as well as ensuring drug integrity (track and trace, serialization), both of which have involved the R&D Packaging with plant operation.
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