Chemicals & raw materials
pharmaceutical perspective and for the patients”. But not all drugs can currently be produced in a tablet form. Bashir gives the example of new drug chemical entities like therapeutic proteins and peptides (TPPs). “These are better than small drug molecules because they are target-specific,” she says. “For example, insulin (a peptide drug) only acts on a specific target site, so it has minimal adverse effect. However, TPPs are more challenging to deliver orally because they consist of biological material, which our body very easily degrades and breaks down.” The biggest challenge, Bashir adds, is for companies to source cheap and affordable excipients that can stabilise and protect TPPs (usually sugars such as dextran, trehalose and pullulan), both during manufacturing processes and in terms of storage and transport, including cold chain considerations. One recent study into additives for vaccine storage to improve thermal stability of adenoviruses found that the use of inexpensive, biocompatible additives to slow down the degradation of virus particles could address the cold chain problem. The study concluded that, while sugars have the advantage of being inexpensive, and continue to show the best performance, they only do so at high concentrations. Nanoparticles and polyols, on the other hand, offer a more costly alternative, but can demonstrate effects at extremely small concentrations. Substitutions like this might prove more expensive – but they also reduce the possibility of side effects in high-risk patients. Such research suggests that conventional approaches to excipients (for example, the use of cheap and basic substances such as sugars and starches) are beginning to shift, to incorporate new types of additives. Yet, as Bashir notes, “although research has demonstrated positive responses and future promise, the biggest issue is the scaling up of these specialised advance formulations and the cost of manufacturing”. In other words, effecting this kind of change across the pharmaceutical industry will be difficult – but unless real change is instigated, “pharmaceutical companies will carry on producing what they’re producing”, Bashir says. “And healthcare systems will carry on purchasing what they produce. It is for benefit of the patients that we have to make the change,” she adds.
Humane instinct At the end of the day, innovations in drug formulation should come down to a question of humaneness. Bashir offers the example of a person who has diabetes: “An individual who has diabetes is injecting insulin every single day. Why change it? Because it is humane to make that change – to put in the investment and the funding, and to try to find an alternative, non-invasive route of administration.”
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
Furthermore, when it comes to vaccines, changes in drug formulation could be revolutionary on a global scale. “Almost all vaccines are injections”, say Bashir. “But say, for example, that you make the change and formulate them into tablets – imagine the potential of that! Because now you could supply them to low resource countries, where the vaccine could be self-administered – people wouldn’t have to travel for miles to get to the nearest clinic where trained personnel can inject it.”
Injectable drugs are more expensive than solid oral dosage forms to produce due to the cost of sterilisation and cold-chain shipping.
“You have to spend a huge amount of money sterilising these injections and maintaining these formulations, because they have to be refrigerated, sometimes at -20ºC.”
The starting point for this change should be patient-centric – but, longer term, it could also entail financial benefits for pharmaceutical companies. As Bashir notes, injectable drugs tend to be more expensive to formulate and produce: “You have to spend a huge amount of money sterilising these injections and maintaining these formulations, because they have to be refrigerated, sometimes at -20ºC. And if you’re transporting them, that’s going to cost a lot of money as well.” It may seem surprising that a discussion of drug delivery innovation should bring us full circle, back to the hard little tablet. But it’s a tried and tested product: oral dosage forms like pills and liquid preparations have endured for millennia because they’re cheap, convenient and easy to administer. The challenge faced by pharmaceutical companies now, then, shouldn’t necessarily be coming up with new routes of administration, but finding solutions to getting new drugs into old forms – and innovations in excipients might just be the key. ●
$8.3bn
The global market for pharmaceutical excipients is
predicted to grow by this amount in 2021 to $10.6bn in 2026.
BCC Research 35
Sergii Sobolevskyi/
Shutterstock.com
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