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Future of solid oral dosage form manufacturing

Professor Ambikanandan Misra
Wednesday, January 24, 2018, 08:00 Hrs  [IST]

The pharmaceutical market for the solid oral dosage forms like tablets and capsules remain well built, dominated and continuously evolving through several innovative tools for pharmaceutical process and formulation development. Owing to certain advantages such as dosage accuracy, stability, patient compliance, greater dose precision and least variability with highest cost efficiency makes solid dosage forms of choice over the worldwide. Since pharma market is growing for drug molecules continuous to pick up race, future of the solid oral dosages will be expected to rely not just on generic products but several other drug molecules with high potency as well, e.g. oncology products. Technological advancements and innovative tools for pharmaceutical process and product development will be the need of the hour. The present topic briefly discusses the some of the tools such as 3D printing technology, Continuous manufacturing, process analytical technology (PAT) tools, etc. Further, manufacturing of pharmaceutical products has been considered as chained unit processes with several after effects, so to reach the optimal goal of the unit process, some monitoring tool is needed rather merely depending upon on operators having experience which is obtained with several trial and errors with quantitative or qualitative measurements. As this trial and error fluke does not work every time to reach optimal goal of unit process.

3D printing technology
The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial-scale manufacturing of complex drug delivery systems using the existing technologies is challenging. Using of outdated current technologies for commercial scale manufacturing of highly engineered drug products are like can of warm. There is an urgent need for innovative technological solution for design and development of solid oral dosage forms. 3D printing technology is an additive process of manufacturing 3D solid objects from melted or liquid objects using a digital processing. This technology relies on computer assisted designs to attain many features like flexibility, fast, and outstanding capability of pharmaceutical manufacturing.

3D proto-typing of layer-by-layer fabrication with different pre-design models to formulate drug materials into the preferred dosage form. FDA approved the first-ever 3D printed-medicine SPRITAM of Aprecia Pharmaceuticals highlights the promising potentials of 3D printing technology in pharmaceutical drug delivery area.
Challenges in 3D printing technology
i) Development of new excipients for 3D printing technology is main concern for adopting this future technology. Nowadays pharmaceutical industries suffer from lack of useful excipients and approval from regulatory for newly develop excipients are very tedious and time-consuming process.
ii) Development of advance and flexible software for designing basic structure of predetermined product.
iii) The sheer scale of investment required is a deterrent for many companies who would otherwise want to experiment.
iv) Regulatory approval of working machines and printing machines are very monotonous.

However, 3D printing technology have potential to bring revolution in pharmaceutical industries with benefits like personalized drug dosing, unique dosage forms, printing living tissue, more complex drug profile release. We believe that with patience and perseverance, this technology will continue to transform into the more safe and efficacious product development.

Continues manufacturing
Batch based production of existing blockbuster molecules for solid dosage form ruled pharmaceutical industry more than 20-year. Continuous manufacturing can be defined as a process where starting materials are manufactured into the final product as a constant flow with an integrated set of equipment, and equipment is controlled to produce required product quality.

Among the key technologies, continuous manufacturing can offers noteworthy innovations in the pharmaceutical manufacturing sector and also motivated by the vision of developing “on demand” personalized medicines. Consistency in product quality and overall process efficiency, more distributed and even mobile manufacturing systems that could be located at the point of use, improving access to novel medicines, opening new market and adds the extra feathers in the cap of continuous manufacturing. PROMISEline and ConsiGma provide complete solution for the continuous production of tablets in pharmaceutical industries.

In corporation of continues manufacturing in a pharmaceutical production process increase system capacity to fullest and optimize their process in all relevant areas. Several key dominances are following:

Verification of product quality and the real-time release of products; Lower investment and operating costs, higher energy efficiency, and lower CO2 emissions; Shorter time to market and greater flexibility in production across the entire product lifecycle.

To the upcoming years, more inclined from batch to continuous manufacturing with advancements in the process controls will turn out to be more clear as industries look to drive the efficiency envelope while concurrently product quality improvement and reducing the time to market.

PAT tools
PAT is a term used for describing a broader change in pharma manufacturing from the static batch manufacturing to a more dynamic approach. PAT has been defined by US FDA as a mechanism/tools to design, analyze, and controls the manufacturing processes of pharmaceuticals through the evaluation of Critical Process Parameters (CPP) which may affect the Critical Quality Attributes (CQA) and finally to Quality Target Product Profile (QTTP).
 
The concept aims by understanding the processes parameters and thus defining their CPPs, and after that accordingly monitoring them in a timely way (preferably in-line or on-line) and thus being more efficient in testing while at the same time reducing over-processing, enhancing consistency and minimizing rejects.

The long-term goals of PAT tools are: To reduce production cycling time; Facilitate continuous processing; Enable real-time release in the manufacturing area; Provides product uniformity; Reduces product change-over time; Increases automation to improve operator safety and reduce human errors; Increase automation and control; and Prevents rejection and re-processing of batches.

To implement a successful PAT project, a combination of three main PAT tools is essential:
Multivariate data acquisition and data analysis tools: Usually advanced software packages which aid in design of experiments, collection of raw data and statistically analyzing this data to determine what parameters are CPP. Investigation of the variables that affect processing can be performed using a formal experimental design. Risk analysis should always be the starting point for allocation of the resources for this activity. It is also important to use prior knowledge to define the range within which the experiments are performed and to exclude experimental areas in which it would be impossible to operate. Utilization of prior knowledge is crucial for ensuring that only a reasonable number of experiments are performed.

Process analytical chemistry tools: In-line and on-line analytical instruments used to measure those parameters that have been defined as CPP. It may include mainly near-infrared spectroscopy; it also includes biosensors, mid-infrared and Raman spectroscopy, fibre optics and others.

Continuous improvement and/or knowledge management tools: Paper systems or software packages which accumulate the quality control data acquired over time for specific processes with the aim of defining the process weaknesses and implementing and monitoring process improvement initiatives.

Pharmaceutical manufacturing sector for solid oral dosage forms remains the most leading and dominant segment in pharma market. To cope up with the future demand and supply of quality drug products, technological advancements and innovative tools for pharma process and product development will be the need of the hour with the existing technological tools.

(Author is with Faculty of Pharmacy, Kalabhavan Campus, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat 390 001)

 

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