Solid dosage forms are a preferred option of drug administration. But, deployment of novel materials and new age manufacturing processes, supported by technology, to meet the evolving requirements of patients would be key to their relevance in future
Solid dosage forms such as tablets, capsules, pills, powders etc. are among the most commonly used pharmaceuticals to treat various ailments. Since ages, they have been a reliable and preferred route to administer medications and generate the preferred pharmacological response.
Yet, with changing consumer demands, advent and progress of newer dosage forms and ever evolving regulations, it has become imperative to re-examine the current products and processes in solid dosage forms. To keep pace with the advancements of the pharma industry and meet the requirements of the present and the future, they will also have to continuously evolve and transform.
Therefore, it is essential to keep refining this dependable and convenient way to administer drugs through innovation. And, this would involve deployment of novel materials and new age manufacturing processes. Hence, the professionals involved in formulation R&D and manufacturing of solid dosage forms have to constantly update their skills and stay informed on the evolving trends, and advancements in this arena.
Therefore, Express Pharma and ACG recently organised a panel discussion on ‘Continually evolving solid dosage forms,’ second in a series of Knowledge Exchanges on this subject. The first one, titled ‘Reinventing Pharma Tabletting, was held earlier this year. Check out the learnings from that discussion at http://www.expressbpd.com/ pharma/cover-story/reinventing-pharma-tabletting/400284/.
This time around, an eminent panel reviewed the progress in solid dosage forms and ascertained that technological advancements are steering newer approaches in the development of these medications.
Dr Shirish Belapure, Managing Director, Zydus Hospira Oncology, the moderator for the discussion very effectively established the relevance and importance of solid dosage forms for the pharma industry today. He informed that solid dosage forms are very important because of their dose accuracy, high stability, cost efficiency and patient compliance.
In the course of the discussion, while several crucial aspects were discussed, the panelists also established that as solid dosage forms continue to evolve, technology will be a major enabler of future progress in this field, creating significant impact in some crucial areas. Let’s examine a few of them.
Ensuring quality
Panelists concurred that automation and digitalisation will drive a high degree of competence and value in the process of development of solid dosage forms. Therefore, new-age equipment and manufacturing technologies are incorporating features to enable segregation between process steps, control contamination, limit and control the impact of environmental
factors on the product etc. to usher improved quality and thereby better outcomes for the patients. Similarly, integrated process control systems and manufacturing execution system (MES) solutions are enabling increased productivity and efficiency in the development and production of solid dosage forms.
development), Zydus Healthcare
Throwing more light on this aspect, Brij Motwani, Vice President & Cluster Head USI Operations, Cadila Healthcare, informed that every company is going for measures such as lean manufacturing, operational excellence, reduce wastages, increase batch sizes, etc to improve operational efficiencies and product quality. He further informed that alternate technologies such as hot melt extrusion, weight granulation, 3D printing will have a great role to play in future and enhance efficiency and quality.
Dr Shirish Dhande, Ex-CEO, ACG Pharma Technologies informed that standardisation would also be key to ensuring quality in solid dosage forms and this would come with adoption of technology.
Manish Chauhan, Associate Vice President, Intas Pharma also recommended going for modification of current technologies to gain faster approvals and sail through regulatory audits. He also pointed out the benefits of these technologies to offer more differentiation in products and safeguard quality.
Cost optimisation
Dr Dhande pointed out that as price pressures mount, the pharma industry is looking for more and more cost-effective solutions without compromising on quality. He opined that this is where technology will have a crucial role to play.
Motwani also highlighted that every industry is looking at ways to contain costs and the pharma sector is no exception. He opined that automation is likely to be answer to a lot of these cost challenges and ensure that we produce maximum at minimum cost.
Adoption of new age technologies in the development and manufacture of solid dosage forms has also led to significant cost savings through the means of simplified processes, better space utilisation, improved energy savings, optimal use of resources, and increased batch sizes.
Experts highlighted that return on investment is also seen in reduced production time and elimination of product failures. This, in turn, provides a lot of benefits to the pharma company and the patients.
Improving efficacy
The growing demand, newer therapies and treatment protocols have made it imperative to bring in differentiation and ameliorate the performance of solid dosage forms as well to improve their ease of use and efficacy. As a result, tech-led innovations and alternative formulation techniques are being applied and adopted to gain better product benefits and meet the changing requirements. This has also led to more patient medication compliance, alongwith better cost-effectiveness and enhanced overall disease management.
Motwani predicts that one machine is going to do a lot of jobs in future such as drying, granulation, blending, compression, coating etc. In the next 20-30 years, one might see that millions and millions of tablets are being manufactured in one small room.
Naresh Gaur, Vice President Operations, Amneal Pharmaceuticals believes that technology will be a gamechanger
but also cautions that scalability of these technologies and processes will be a major challenge that would have to be tackled. He emphasised on the need for the adoption of quality-by-design (QbD) and effective utilisation of new-age technology to achieve it effectively.
Dr Dhande recommended that the industry needs to have a more risk-based approach to eradicate errors. He empahsised that it is important to understand the quality parameters well and maintain them with the help of technology rather than trying to rectify errors which have several adverse after effects in terms of costs and compliance.
Regulatory compliance
A range of new age processing technologies, including continuous manufacturing are being utilised in the current times to produce high-quality, solid dose, pharma products. Sensors, automated transfer system, cameras, automation in compression and coating machines etc. are a few examples. The use of these technologies have also brought in better understanding of the QbD concept, leading to optimisation of raw material, formulation, and processing variables. This, in turn is aiding regulatory compliance.
Gaur explained this point with a very pertinent example. He pointed out that paracetamol is an age-old product but we continue to see quality and efficacy issues even in that. These things can be avoided through QbD, enabled by technology. He also accentuated that as new regulations such as GDUFA come into place, it will be essential for pharma companies to restrategise and be future ready.
Interestingly, regulators themselves are also using technology to ensure that the companies adhere to their requirements. Dr Hemant Koshia, Commissioner, FDCA Gujarat explained how technology is not only enabling regulatory compliance but also helping in regulatory enforcement. He cited the example of how the Gujarat government has a database maintained through a software for product licenses given out to pharma companies since May 1, 1960, when Gujarat came into existence as a state. He informs that they have the details of over 375850 product licenses given out and the list is growing with each passing day. Of these licenses, 65 per cent of them are for solid dosage forms.
Dr Koshia also spoke on how technology ranging from simple, chemistry-based kits to high-end technologies such as LED infrared, X-ray analyser, photometers, mobile drug testing labs etc., are being utilised help enforce adherence to
regulations.
What does future behold?
The discussion very clearly brought out that the pharma industry is undergoing a change which is unprecedented and the market for novel products will continue to grow.
However, as Ajit Kanetkar, Head Process Technology and training, ACG highlighted in an informative presentation, solid dosage forms have been around for centuries and they are evolving at a very fast pace, falsifying predictions that they would cease to exist.
But, solid dosage forms will also have to tackle the challenges that hamper its future prospects such as poorly soluble drugs, huge tablet size limitation, outdated manufacturing techniques, obsolete equipment, lack of trained resources etc.
Thankfully, with the advent of new coating technologies, avant-garde manufacturing technologies, novel designing methods, and innovative formulation techniques and delivery methods, solid dosage forms can disassociate itself from the disadvantages.
Thus, it is clear that pharma companies need to adopt alternate processes. They would also have to invest in innovation which will enhance the quality, efficacy and reproducibility of solid dosage forms and be better equipped to meet the requirements of patients.
Some Upcoming trends & technologies
3-D printed drugs
Tablet is made by 3-D printing layers of the powdered drug. The advantage of this process is that the drug’s unique structure allows it to dissolve considerably faster than the average pill.
Digital pill
A new ‘digital pill’ can tell doctors whether a patient has taken his or her medicine. The pill, which was approved by US Food and Drug Administration on Nov. 13, sends a signal to a wearable sensor when a patient has taken the medication, and that information is then sent to a doctor’s office.
PODRAS (Paradoxical Overdose Resistance Activating System)
It deliberately regulates the bioavailability of active ingredients in both generic and non-generic medications in a way that reduces the opportunity for overdose and/or abuse. PODRAS delivery technology is designed to prevent overdose when more pills than prescribed are swallowed intact.
Osmotic Release Oral System (OROS)
It is an advanced controlled release oral drug delivery system in the form of a rigid tablet with a semi-permeable outer membrane and one or more small laser drilled holes in it. As the tablet passes through the body, water is absorbed through the semipermeable membrane via osmosis, and the resulting osmotic pressure is used to push the active drug through the opening(s) in the tablet.
Source: Sanjay Motipwer, GM (Pharma technology, formulation & development), Zydus Healthcare
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