The Reign of Oral Solid Dosage Forms in the Era of Biopharmaceuticals

Despite the usherance of a plethora of novel drug delivery systems, oral solid dosage (OSD) forms still remain the most popular among other dosage forms. Tablets, capsules, granules etc. still reign the global pharmaceutical market and make up nearly 60% of the total drug products. Amidst the growth and demand for biologicals and biosimilars, the development pipeline of OSD products has continued to expand. OSDs top the list for being patient friendly as they are simple to administer. For drug makers, manufacturing OSDs are cost-effective and convenient unlike biopharmaceutical products which are comparatively more complex. They offer greater physical stability and are easy to handle.


As more and more complex molecules are being introduced today with the aim of delivering targeted therapies, working with them or formulating them into OSDs is increasingly becoming challenging. There has been an increase in the number of poorly soluble drug candidate where enhancing the oral bioavailability of these molecules becomes a must. Development of drug products with a modified release profile has been a well-known approach in dealing with this challenge. Multi particulate drug delivery systems are setting a new trend in OSDs that offer the flexibility of attaining dual release profiles.


The emphasis of many companies is now moving from blockbuster drugs toward cure for rare diseases intended to serve smaller populations. With a rise in the number of such specialized products, the industry is focusing on flexible and agile manufacturing options to address this shift from manufacturing low-cost drugs for a large population to high value targeted therapies. The trend of manufacturing smaller batch sizes is growing which is well suited to serve today’s highly fragmented market needs. Reducing the production volume also speeds up the process resulting in faster market reach.


The pharmaceutical industry is traditionally known to manufacture OSDs in batches. Batch production requires the completion of one manufacturing step to proceed to the next. Similarly, a new batch can be taken up only after the completion of the previous one. This type of manufacturing employs established manufacturing processes that have largely remained practically unchanged over the years. This essentially means that these processes have undergone the necessary optimization and offer very limited scope for betterment. This had led pharmaceutical manufactures to move towards continuous manufacturing. A continuous flow operation helps save time, offers greater efficiency, flexibility, increases productivity, involves minimal human intervention leaving little room for error and reduces wastage or losses. The advancement of technology has facilitated the pharmaceutical industry to switch from batch to continuous manufacturing swiftly.


OSDs though one of the oldest known drug delivery systems undoubtedly are the most preferred even to this day. The endurance of their popularity can be attributed to the opportunity they offer further improving them as more advanced products.

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