Serialisation is the buzzword transforming pharma packaging industry
Pharma packaging is one such pillar for business development which has evolved and is still evolving in an accelerated pace. The motive has been defined differently from time to time from containment and protection, to branding to user-friendliness.
Now is the era where the business perspectives are driven through regulatory compliance, customer focus, and environmental sustainability. So maintaining the same packaging should also be designed with a purpose to meet the mentioned perspective as
Regulatory changes are driving packaging innovation globally. Track and trace of the products throughout the supply chain to address the counterfeit issues. Serialisation is the buzz word transforming pharmaceutical packaging industry.
Evolving Product Composition – Rethinking Primary Packaging
These days the focus is on biologic drugs. Most biologic drugs being injectables; glass is the logical choice for primary packaging. However, some biologic drugs are found to interact with glass, delaminate it, causing flaking. So, it is necessary to keep this in mind while developing the primary packaging.
Customer focus and intelligent packaging
An ageing population and increasing life expectancy provides room for packaging innovation. While digital medicine with in-built sensors is making inroads in compliance monitoring and connected care, features such as daily dose markings on the pack are common, advanced features such as digital timers and alarms on packaging reminding patients of the time for next dose are the need of the hour.
Accurate dosing and dose monitoring: Dose monitoring features in packaging are increasingly playing an important role in abuse deterrence as well as patient adherence. Simple metered dosing systems to calendar-enabled closure technologies tracking and counting pills as they are dispensed and send the data to a smartphone. Unitdose packaging with key drug details incorporated in every dose is gaining popularity in hospitals and clinics as a convenient and safe option, driving allied trends in packaging.
Tamper protection and Child Lock: With a high contribution of pharmaceuticals unintentional childhood poisoning, need for child locking mechanisms is critical. Packaging industries continue to incrementally innovate in striking the right balance between making it inaccessible to children but not too difficult for elderly patients. Several innovative packaging mechanisms are evolving in pharmaceutical packaging, including braille printing for blind people
Sustainability: Lot of packaging waste generated gets dumped into ocean, destroying marine life. In the process, it is destroying the ecological balance.
Business will sustain with its people and mankind will sustain only with a safe and healthy environment. Packaging shall be designed in a way to meet the three main mantras Reduce, reuse and recycle.
Packaging has a profound impact across the entire supply chain
The Indian pharmaceutical industry is undergoing significant growth. Even at current rates of seven to eight per cent CAGR, the industry’s annual revenues can grow to about USD 80 to 90 billion by 2030. As we enter in the new decade, pharma will continue to face the challenges from the past. Particularly, the globalisation of drug supply, delivering new product types, meeting demand from emerging countries, the rise of chronic lifestyle conditions such as obesity and diabetes, and the growing threat of counterfeit and falsified medicine.
To fulfill these requirements, the demand for pharma packaging products will rapidly evolve in the next three to seven years as portfolio diversification strategies translate to revenue realisation milestones. This will drive expanded demand in several products categories across primary and secondary packaging.
In the coming decade, there will be numerous changes within the pharma industry:
1. Increasing in the number of complex formulations
2. More active engagement in biopharmaceuticals
3. Increasing price pressure and competition within generics, regulatory changes and critical emphasis on the product safety and integrity
4. Increasing the focus on patient-centricity etc.
ANDA Filled by Indian generic companies – (December 2019)
A- Solidoral doses
D- Others (Inhalation, topical, Transdermal etc.)
The above chart shows that about 85-90 per cent of the ANDAs held by Indian pharma companies are comprised of oral solids but there is a planned shift towards more complex molecules whose packaging is not only complex but also should be based on patient safety, patient compliance and patient convenience as well as patient-centric, intelligent and smart packaging for coming decade.
So, in the face of such disruption, we can expect some leading developments from Pharma packaging in the coming decade.
A) Focus on patient safety, compliance and convenience.
The patient today has progressed from being the passive recipient of drugs to an active partner in the entire drug development process, right from the formulation type to the type of packaging. Digitalisation and awareness through social media have been the key driver of this change and the industry has been proactive in recognising the importance of ‘patientcentricity’, better to put as ‘customer-centricity’.
Some examples of patient safety, compliance and convenience pack
◗ Child-resistant packaging and Senior Friendly packaging
◗ Wallet pack
◗ Unit dose packaging with CR features. Unit dose packaging to avoid contamination of the drug product
◗ Child-resistant medication with timer or alarm caps
B) Smart Packaging and intelligent packaging
Embedding advanced features into packaging such as sensing or wireless communication makes packaging ‘smart’ which can provide significant functionality. The packaging then becomes not only a way to protect and provide information on medicines but can add a whole host of extra functionality. The smart packaging can reduce supply chain losses through enhanced environmental monitoring and support improved patient adherence through smart adherence packaging.
For an example – Smart Bottle uses Biometric (fingerprint) authorisation to ensure that patients—and only patients—receive their prescribed doses of liquid opioid medications. If an unauthorised user tries to tamper with or force-dispense medication from the Smart Bottle, the device immediately neutralises the opioid.
C) Device and self-administration
Changing in hospital administration to self-administration process is increasing rapidly in the market. So, the medical devices are taking the leading role for the coming decade.
D) Connecting device
A connected medical device can collect and store data about patient use and trace the effectiveness of a particular device and treatment to help them to do so.
Utilising connectivity in drug delivery devices such as injectors and inhalers, connected health solutions help pharmaceutical companies, healthcare professionals and patients, improve how people take their medication. In addition to medication tracking, these systems support patients through reminders, incentives and peer communities to improve disease management, medication adherence and, ideally, outcomes. Additionally to this, we hope the connecting device will be used for the emergency treatment of the patient in the coming decade with a secure channel.
E) Blow fill seal(BFS) for unit dose stérile product
The inherent safety of the process, packaging sterile products under aseptic conditions without human intervention, has led the FDA to characterise Blow/Fill/Seal technology as an "advanced aseptic process", indicating its use as a preferred technology going forward for thecoming decade.
G) IoT (Internet of Things)
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