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MR dosage forms revolutionize patient compliance: Girish Nihalani
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Shardul Nautiyal, Mumbai
August 24 , 2024
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In the ever-evolving pharmaceutical landscape, modified release (MR) dosage forms have emerged as a groundbreaking innovation, providing solutions that significantly improve patient compliance by simplifying complex drug regimens.
MR formulation development, despite the challenges posed by the need for advanced equipment, regulatory knowledge, and technical expertise, continues to drive the industry towards more patient-centric drug delivery systems. This push for innovation is fueled by a growing demand for simplified administration of increasingly complex molecules, as well as the need for effective management of chronic conditions like cancer, diabetes, and hypertension.
Pharmaceutical expert Girish Nihalani, a veteran with over 18 years of experience in the field and a Master’s degree in pharmaceutical sciences from Mumbai University, is at the forefront of this revolution. Nihalani's career, spanning multiple pharmaceutical organizations, has been centered on the development of complex MR products designed to meet the stringent demands of the US market. His expertise lies in tackling the challenges posed by new active pharmaceutical ingredients (APIs) that often suffer from poor solubility, bioavailability issues, and stability concerns, all while ensuring that these formulations can be successfully scaled up for commercial manufacturing.
"MR formulation development isn't just about extending the release of drugs; it's about designing innovative, patient-focused solutions that improve adherence by reducing the complexity of dosing regimens," explains Nihalani.
"This means developing products that allow for fewer doses, minimize side effects, and offer convenient administration methods—ultimately making life easier for patients who are already dealing with chronic health issues," he adds.
One of the key drivers behind the development of MR dosage forms is the need to address non-compliance among patients. Non-compliance is a widespread issue, often stemming from factors such as pill burden (the need to take multiple pills daily), high doses of medication, and intricate dosing schedules that may require medication to be taken before or after meals. These challenges are further exacerbated by the side effects of drugs, such as gastrointestinal upset or difficulty swallowing or chewing pills. For patients with chronic conditions, the physical burden of disease management is compounded by the emotional toll it takes on their well-being.
Nihalani’s work focuses on alleviating these burdens through the development of MR formulations that offer more manageable dosing schedules and reduce the likelihood of missed doses. By extending the release of drugs over longer periods, MR formulations minimize the need for frequent dosing and help maintain consistent therapeutic levels in the body.
For example, extended release (ER) formulations, which are designed for drugs with a biological half-life of 2 to 8 hours, can provide sustained drug release over 12-24 hours. This not only reduces the number of pills a patient needs to take daily but also enhances adherence by minimizing the chances of missed doses. Delayed release formulations, on the other hand, are tailored to control drug release in specific parts of the gastrointestinal tract, preventing degradation of the API in the stomach and reducing side effects associated with the upper GI tract.
"Patients need solutions that integrate seamlessly into their lives, rather than imposing more complexity on already challenging conditions. By focusing on optimizing drug release profiles through the intelligent design of MR formulations, we can offer patients a better quality of life and a more consistent therapeutic effect," says Nihalani.
The development of MR dosage forms demands not only an in-depth understanding of the physiochemical properties of APIs but also a keen awareness of how these APIs interact with the excipients used in the formulation. Excipients—substances that are added to drugs to facilitate their manufacturing and enhance their stability, bioavailability, and overall effectiveness—play a crucial role in the performance of MR products.
Need for expertise lies in the meticulous selection and optimization of these excipients. Polymers, such as hypromellose, hydroxypropyl cellulose, ethyl cellulose, polyvinyl pyrrolidone, and methacrylic acid co-polymer, are just some of the functional ingredients that Nihalani uses to modulate drug release kinetics. These polymers can be fine-tuned to achieve desired release profiles by manipulating their chemical properties, grades, and interaction with other excipients in the formulation. Additional non-polymeric components, such as plasticizers, processing aids (e.g., talc, magnesium stearate), pore formers, and surfactants, are also carefully considered to enhance the final product's performance.
This intricate balancing act of selecting the right excipients and optimizing their performance in the formulation is key to achieving critical quality attributes such as consistent release rates, stability, and bioavailability. Failure to select the appropriate excipients can lead to problems such as API degradation, high levels of impurities, or promising in-vitro results that fail to translate into effective in-vivo performance.
"The formulation process is a delicate dance between chemistry and practicality. We have to ensure that the final product not only meets the necessary regulatory and manufacturing standards but also delivers real, tangible benefits to the patient," notes Nihalani.
The future of MR dosage forms is bright, with the oral solid dosage pharmaceutical market projected to grow at an impressive compound annual growth rate (CAGR) of 6.4%, reaching a market valuation of USD 1.0 billion by 2032. This growth will be driven by the continued introduction of new technologies, the development of alternative administration methods, and a growing emphasis on cost-effective solutions that offer better patient outcomes.
One of the most exciting areas of innovation in MR formulation development is the oral delivery of peptide molecules and the processing of APIs to leverage their amorphous properties. Peptides, due to their size and instability, have traditionally been difficult to formulate as oral dosage forms. However, advances in excipient technology and biopharmaceutical knowledge are opening up new possibilities for the oral delivery of these complex molecules.
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