Examining Trends in Oral Solid Dosage Manufacturing – Pharmaceutical Technology Magazine
The state of oral solid dose manufacturing is influenced by new approaches, novel technologies, and the structural evolution of the raw materials market.
When one thinks of medicine, the first image that comes to mind will likely be a small white pill, or perhaps an orange bottle full of them. While biologic therapies and various parenterals have experienced significant advances in recent years, the ubiquity of dental solid dosage (OSD) drugs —whether pills, tablets, capsules, soft gels, effervescence, gummies, or any other variant— remains at the forefront of the particular industry.
“OSD drug delivery systems are predominantly preferred over a parenteral (injection or even drip) intravenous drug shipping for many reasons, ” says Paul DiMarco, vice-president associated with Global Commercial Operations, BioSpectra. “Not the least of which being ease of use, lower purity demands due to the acidic environment of the particular stomach, and little or no medical supervision during administration. ”
The popularity of OSD puts it at the heart of the pharmaceutical industry, and it is particularly susceptible to emerging trends or market forces. This article examines the latest systems and trends unique to OSD, as well because takes a look at the particular greater marketplace forces influencing its production.
Embracing new methods
One process that will the pharmaceutical industry as a whole has been attempting to adopt, where possible, is continuous manufacturing, due to the decreased resource drain plus increased flexibility continuous processes provide. However, while constant manufacturing has seen steady growth, OSD has faced some difficulties in switching over due to the particular nature associated with its manufacturing process—the first oral solid dosage drug manufactured via a continuous approach was not approved until 2015 (1). Largely, these difficulties resulted from the equipment being designed with downtime in mind.
In this regard, numerous equipment suppliers have stepped in to try to ease continuous production hiccups. For instance, L. B. Bohle’s QbCon1, a continuous dryer and granulator, uses a novel process to allow for infinite operation without needing to stop the machine for cleaning (2). Similarly, Herma US released modules for its 132M HC Wrap-around Labeler that allow for it to be integrated into a continuous manufacturing process without requiring downtime for replacement paper (3). In this vein, companies have come to the understanding that facilities must be developed with continuous “powder-to-tablet” capabilities in thoughts.
On the client end, there has also been increased demand for other new techniques, as Robert Sedlock, director at Natoli Scientific, notes.
“In the past few years there offers been a push with regard to collecting data in the more scientific approach. USP [United States Pharmacopeia] published a new chapter (4) concerning tablet characterization methods, which require instrumented pill presses, ” says Sedlock. “There will be now a higher demand regarding instrumented single-station machines, rotary tablet presses, and compaction emulators/simulators. Understanding material mechanical properties is now a standard in the OSD industry. ”
This standard is a natural evolution of the current pharmaceutical business: as information integration becomes more pronounced, client companies are going in order to want more detailed information to refine their procedures. Savvy manufacturers will build and design processes with this in mind as a means associated with satisfying ever-increasing data demands, which will certainly in turn continually influence the particular technologies plus approaches of OSD manufacturing.
Analyzing materials sourcing
A striking dichotomy has emerged in finding for the two components of mouth solid dose drugs, excipients and APIs. Excipients are usually typically considered more complex than APIs, largely as a result of their multi-component nature. This characteristic often results in the performance impact from the various components being not really well understood; in the similar problematic vein, the composition profiles associated with complex mixtures may not be well-defined. In contrast, APIs are comparatively simple mixtures—they are improved by reducing the presence of all other chemicals, which can render them inert or even result in unintended side effects (5).
However , the stark difference in relative complexity has shaped who is producing them. Because excipients are relatively complex formulations, they require significant regulatory oversight to ensure consumer safety. Consequently, they are largely manufactured in countries with well-regarded, overarching regulations; North America holds the largest share within the pharmaceutical excipient market, followed by Europe (6).
“Pharmaceutical companies in the particular United States and Europe are held to a rightful standard simply by [FDA]—one that is not equally experienced by their own counterparts within China and India, ” says DiMarco. “These businesses use higher purity ingredients and fine chemicals sourced from local manufacturers plus, consequently, produce higher quality [and] a lot more consistent, more sophisticated finished drug products. ”
APIs, on the other hand, do not need to be quite since closely scrutinized, allowing countries like India and China, who possess less stringent regulations and much lower labor costs, to leverage those characteristics to gain a manufacturing stranglehold. Whilst it should be noted that there is some dispute over the precise numbers, in particular because most medication manufacturers perform not need to disclose where they source APIs, in 2017 the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) estimated that will 40% of global API production was coming from China in the time of the particular report (7). Similarly, a 2021 report from Mordor Intelligence, the marketing intelligence firm, indicated that approximately 75% to 80% associated with APIs imported to the US were coming from The far east or Indian at the time of their particular report (8).
This dichotomy in materials sourcing offers shaped the particular landscape of the oral solid medication dosage manufacturing market. For instance, while presently there have already been calls in order to reshore manufacturing following the supply chain interruptions brought on by the COVID-19 pandemic, the reliance of the US on these types of countries intended for API sourcing complicates that matter; it is especially exacerbated by desires to reduce drug costs, which necessitates outsourcing to nations who can price relative to their labor expenses.
“The supply chain security issues that began with tariff wars between China plus the US ALL, followed simply by the outbreak, continue through this day along with strained provide chain logistics and natural material capacity constraints, ” says DiMarco. “The worsening relationship among the PEOPLE and Tiongkok could quickly lead in order to more serious conflict and could easily become a good existential event that would dwarf in comparison almost all previous challenges regarding supply chain issues and constraints. ”
1 . Vertex Pharmaceuticals, “FDA Approves Orkambi, ” Press Release, July 2, 2015.
2. L. B. Bohle, “Continuous Granulation and Drying for the particular Pharmaceutical Industry QbCon 1 – R& D, ” www.lbbohle.com , accessed Oct. 28, 2022.
3. Freudenberg Medical, “Freudenberg Medical Launches HeliFlex TPE Tubing from Bioprocess International Conference, ” Press Release, Sept. 29, 2022.
4. USP, “General Chapter < 1062> Tablet Compression Characterization, ” USP 36–NF 31 (Rockville, MD, Dec. 1, 2017).
5. W. Carlin, et al., Pharmaceutic Technology 46 (8) 2022.
6. IPEC Federation, Qualification of Excipients for Use in Pharmaceuticals (IPEC, Brusells, 2nd ed., 2020).
7. MHRA, Medicines and Health care products Regulating Agency International Strategy, www.gov.uk (2017).
8. Mordor Intelligence, Active Pharmaceutical Ingredients (API) Market-Growth, Trends, COVID-19 and Forecasts, (2022 – 2027) , Market Research Report, 2021.
About the author
Grant Playter is usually the Assistant Editor to get Pharmaceutical Technology , BioPharm International, plus Pharmaceutical Technologies Europe.
Vol. 46, No . 10
When referring to this article, please cite it as G. Playter, “Examining Styles in Oral Solid Dosage Manufacturing, ” Pharmaceutical Technology 46 (11) 26-27 (2022).