Understanding the Need of Quality Excipients in Pharma Industry

If we want to define quality, we will say that it is conforming to the earlier defined specification or meeting the expectation. However, the quality is a relative term. For some it may be excellence, for some, it is value for money or just the convenience.  It is a multifaceted concept, having different levels of dimensions but it is important for users.

For companies, quality should meet business requirement, meet the client expectation, provide satisfaction to the users and most importantly it should be free from all defects.

When we are discussing pharma products, it has a direct impact on people’s life and health. Pharmaceutical companies cannot compromise on the quality of ingredients used in the production of medicines.

There will impact on following things if companies fail to adhere to the quality requirement

• Therapeutic effects will get hampered and may lead to prolonged illness or fatality
• Toxic or adverse reaction
• Wastage of financial resources
• Loss of credibility in the market

Therefore manufacturers have to ensure the quality and uniformity of the various ingredients that are used in the production process of medicines. They must use all the techniques which will control the quality of products.

Any medicine cannot be produced without Active Pharmaceutical Ingredient (API) these are therapeutic substance and the inactive ingredient i.e. Excipients these are non-therapeutic substances. API is manufactured specifically for a particular drug, therefore these are generally modified in accordance with the patient, the accuracy of dose, consistency, and reduction of side effects. And excipients are not produced specifically, as it can be used in various industries like dietary supplements, food, personal care products and cosmetics etc. The quality of any medicine depends not only on API but also on Excipient.

Comparing API and Excipients, We Will Find Out That:

1) Manufacturing plans of API are concentrated towards pharmaceutical use; Excipients are used in multiple ways.

2) API has high value but is required in low quantity, Excipients are required in high volumes but have low value.

3) API can be procured from limited sources; Excipients can be procured from multiple sources.

4) API has clear rules and Excipients are customer oriented.

The Need of Quality Excipients

Public Awareness:

There is an increasing trend in public to know more about the ingredients of the product or medicines they are consuming. Consumers are now more aware of the substances used in the production of drugs. It has resulted in establishing the higher standard for quality and control of excipient production. And moreover, companies cannot be negligent while supplying drugs which are designed to cure disease or save the life of patients.

Regulatory Bodies: 

Regulatory bodies are bringing a change in the working of the pharmaceutical industry. There are various quality norms which excipient producers have to comply with. One of the important norms is about the traceability i.e., companies have to maintain the record of each and every product, where it came from and where that product landed up.

Patent Expiry of Key Products:

This is the major problem many pharmaceutical companies are facing. Once the patent of their key products expires, they face the competition from the generic products. Increase in the competition from the other producers and also from the users to down the price, companies are looking for developing new patentable drugs to give competition to generic medicines.

Cost Reduction:

All the pharmaceutical companies are looking for cost-cutting; this has forced excipient producers to concentrate their efforts on enhancing the quality by improving the manufacturing process and developing innovative drug delivery solutions.

Advanced Technology:

Introduction of nanotechnology has redefined the concept of excipients. More producers are promoting combination excipients.  It offers improved stability and the release of the drug. These are cost-effective and critical to Quality by Design projects by pharmaceutical industry.

Meeting the Challenges:

These mentioned differences and the need for higher quality of excipient which is the key ingredients of medicines make it important to understand Goods Manufacturing Process (GMP) for manufacturing Excipients:

• The nature of the manufacturing process.
• The infrastructure required by the industry.
• Acknowledgment these excipients will be used across in many industries.
• It can have multiple uses.
• It should have the traceability so as to find investigate the defects in medicine caused by excipients.

To Sum-Up

The execution and functional attributes of an excipient are essential parts of its quality, as the improvement, production, and execution of pharmaceutical dosage forms depend intensely upon excipient physical and chemical properties. Excipients being an irreplaceable part of medicines, therefore must be assessed for their safety and dependability. The safety affirmation of excipients helps the formulator to design a viable and safe dosage form by utilizing of effective and safe excipients. In this way for an excipient to be in a formulation, it must be very steady, safe and viable, or more all it must agree to the expectation of the formulation. In addition to adhering to the standards of FDA and cGMP and compendia such as IP/ USP-NF/ BP/ JP. NB Entrepreneurs is closely working for higher quality of excipients.

Ref Links:

1. https://qualitymatters.usp.org/elemental-impurities-their-impact-drug-quality
2. http://www.drug-dev.com/Main/Back-Issues/Understanding-the-Role-of-Excipient-Functional-Cat-340.aspx
3. http://www.pharmabiz.com/PrintArticle.aspx?aid=66330&sid=21
4. http://emea.ingredion.com/chooseapplication/Pharmaceuticals.html
5. https://books.google.co.in/books?id=fnkxDQAAQBAJ&pg=PT21&lpg=PT21&dq=high+quality+excipients&source=bl&ots=35jmNwhaNd&sig=47S1cwgSJHau8t-6IZTwmaJbHqE&hl=en&sa=X&ved=0ahUKEwig_pHsyPjbAhVUXisKHQMNAXU4FBDoAQgsMAI#v=onepage&q=
   high%20quality%20excipients&f=false
6. http://www.pqg.org/pdf/IPEC_PQG_GMP.pdf
7. https://www.gmp-compliance.org/gmp-news/handling-of-apis-and-excipients-new-guidelines-in-chapter-5-of-eu-gmp-guide
8. http://www.pharmtech.com/current-trends-and-challenges-excipients-market
9. https://www.researchgate.net/publication/234851297_Significance_of_Pharmaceutical_Excipients_-_A_Review