Except from World Pharma Today's article
August 24, 2020
Manufacturing drugs is one thing but its effective usage is another. Howsoever, complex the treatment or its term be, it all boils down to the dosage and its form. Pharmaceutical Companies today are doing their bit to ensure that the dosage to the patients reaches in its most-liked form. With all that is going around, while reconstructing the design and application pattern, one of the most important elements i.e. scalability is well taken into account. World Pharma Today, in its quest to gather information on the latest trends in the dosage forms, puts forth the views of industry experts who confirm their inclination towards it and how they have become increasingly conscious about the soaring aspirations of the patients.
Nasal dosage forms, wearable technology and injectables are witnessing express innovation and no pharmaceutical company is refraining from trying out options that could help them build a promising path. In this article, we also throw light on the extent of challenges faced by the drug development companies and how they have been coping up on the delivery front. To be customer-centric, one has to be very particular on how effective the dosage comes out and whether or not it has been received well by the patients. Through this piece, we have a crystal clear picture of the current processes that are becoming a norm in the drug development landscape.
The motive of the task undertaken by the pharmaceutical companies today lays out a plan that talks of the innovations taking place in the drug form and also the effects that the dosing regimen is going to have because of it. Experts thereby do share their experience and how the manufacturers have involved themselves lately in continuously working out for a solution-driven, customized, and overall a liked-by-all alternative that is here to stay.
Ramarketing roundtable feature on ‘Oral Solid Dosage’
World Pharma Today recently spoke with Lonnie Barish, VP business development and marketing, Bora Pharmaceuticals about trends and innovation in drug dosage forms.
1. With the pipeline dominated by potent small-molecule compounds intended for oral delivery, what is challenging drug developers most when it comes to delivering these kinds compounds to patients effectively?
The drug development pipeline is being filled with harder to formulate and manufacture compounds as well as manufacturers looking for ways to extend their patent life. The increasingly potent active pharmaceutical ingredients (APIs) reaching patients today are requiring more complex delivery strategies to ensure both safety and the desired therapeutic effects.
Formulators are being challenged on three important fronts when it comes to developing their “difficult” compounds and APIs into effective medicines:
- Low solubility
- Low permeability
- Short half-life
Many of those issues can be overcome by precisely controlling the delivery of API payloads and carefully managing their release in-vivo. More and more commercial contract manufacturers like Bora Pharmaceuticals are being tasked with developing complex modified release dosage forms that require a high level of technical skill.
Not only are today’s modified release technologies effective for today’s potent, challenging APIs, but they are also proving useful tools for improving existing formulations, thus paving the way for line extensions and other lifecycle management strategies.
For example, the FDA’s accelerated 505(B)(2) development pathways are allowing drug developers more economic routes to breathe new life into existing products. The FDA 505(B)(2) pathway allows drug developers a faster route to improve existing drugs. This development route is helping pharma develop new dosage forms that are longer acting, easier to swallow or combining two active ingredients in a new way to simplify treatment.
2. Given the complexities and challenges of manufacturing safe effective medications of all kinds, what recent innovations and processes are helping the industry formulate and finish complex orally administered drugs more efficiently?
Extrusion-spheronization is a formulating and processing technique for controlling API delivery. Suitable for a broad range of oral solid dose therapeutics, extrusion-spheronization offers an efficient route to more effective, patient friendly therapeutics and a reliable, effective way to manufacture today and tomorrow’s complex oral solid dose drug products.
Extrusion-spheronization creates bead shapes that offer superb functional and manufacturing utility while supporting a wide range of release profiles, depending on the formulation.
Although well understood, the process and its core technologies have seen significant improvement over the decades, with advances decreasing variation, increasing yield, and throughput among other benefits. Bora has kept pace and offers extensive capabilities and experience applying the process in an advanced CGMP environment.
3. Patients are front-and-center in drug development. What drug delivery technologies and dose forms are proving effective to meet patient friendly therapeutic goals?
Designing and formulating dose forms to better suit a given patient population’s specific needs to treat disease more effectively – in principle – is a patient friendly strategy.
Orally administered drugs are by far the preferred dose form. Most patient groups respond well to taking oral medications that are easy to swallow, require fewer doses to be effective (for longer periods), and reduce or eliminate unpleasant side effects.
For drug strategists looking to develop patient friendly oral solid doses (OSDs), there are two emerging finished dose forms that extend extrusion-spheronization’s dose-controlling functionality and offer drug developers economic ways to explore and exploit complex patient friendly OSD drug strategies:
I. Fixed-dose combinations (FDCs) combined, modified release single-capsule forms
II. Multi-unit particulate system (MUPS) tablet designs
Multi-particle, multi-sphere finished-dose forms, for example, are consistently demonstrating higher levels of desired reproducible PK and PD behaviors (including insoluble potent APIs) resulting in improved therapeutic effect in patients.
4. Engaging strong external partners has become a common theme of successful drug development. What is your organization doing to support the drug strategies of clients and partners more effectively?
One of the biggest changes to the pharmaceutical manufacturing industry is the increasing reliance on external partners to develop and commercialize their products. Broadly the change has been extremely positive for the entire pharma supply chain by promoting quality, innovation, and cost-efficiency.
Companies engage international manufacturing partners for several reasons. Access to lower-cost manufacturing and proximity to emerging markets are two prominent drivers. But considering recent development paths and other trends, securing strategic experience and expertise is playing an even bigger role in successful drug strategies.
Although managing costs are a central theme, access to capacity, integrated technical capabilities, and leading-edge technology is prompting many of our recent partnerships, while sustaining our more mature relationships, especially those involving commoditized, high-volume products.
Unlocking an API’s therapeutic value requires focused science, technical expertise, and operational excellence to do it wellandmeet the industry’s commercial, financial, and regulatory expectations. It is becoming increasingly recognized that, by the very nature of working on many compounds for numerous clients, CDMOs can offer these broad capabilities.
5. Given the drug pipeline what is on the horizon for drug delivery development and technology innovation?
Demand for therapeutics of all kinds is increasing at an incredible pace now that much of the world has better access to healthcare and there is a demand to treat more diseases with larger populations. This has also prompted the development of medications to treat or cure more “niche” diseases. It is also prompting further development and exploration of new modalities, genetic techniques, and chemistries to make better performing drugs for more people.
The drive towards enhancing patient compliance and better outcomes will likely prompt the development of even more complex but functional drug forms, including combining APIs for related disease states and deploying them in bilayer/tri-layer tablets and more sophisticated combination products.
Personalized/precision medicine continues to play an important trend in pharmaceutical development. Personalized medicine principles are being applied in new and innovative ways including diagnostics, genetic profiling, and the creation of advanced analytical techniques.
Equipped with these tools, researchers can gain deep insight into different patient sub-populations and the pharmacokinetic and pharmacodynamic effects of drug substances. With this data, researchers will become even more successful in developing the effective patient friendly pharmaceuticals that societies are demanding now to meet the future of healthcare.