RETHINKING PACKAGING WITH R&D

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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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