Tablets are the most commonly used form of drug delivery as they are not only easy to produce but can also be produced in large quantities.

Dry granulation, which unlike wet granulation is a continuous process, is an established procedure in the production of pharmaceutical solids. It is employed not only for products that are sensitive to moisture or temperature, but also for its cost advantages.

In comparison to wet granulation, no energy-intensive drying processes are needed. This saves a major investment in equipment and production space and leads to a lower cost per lot thanks to the savings in energy cost. Without a drying step, it becomes superfluous to stock up on, distill and dispose of industrial solvents.

Bohle dry granulators guarantee a compacting process with a high material throughput of up to 400 kg/h. This allows different products and lot sizes to be produced with one machine.

Dry granulators are differentiated based on their roller configuration. There are granulators with rollers configured horizontally, vertically and diagonally.

L.B. Bohle focuses on horizontally configured rollers in the compacting process. Among the advantages of this configuration are a better de-aeration of the screws and a shorter discharge route for the slugs. In addition, dry granulators vary in terms of width, diameter and surface characteristics of the rollers.

The space between the rollers is divided into three zones. A pre-compaction of the particles takes place in the slip region (feeding zone). The main compaction of the particles takes place in the compaction zone; depending on the material in use, this can take place through particle deformation or particle fragmentation. The material release (extrusion) takes place in the third zone.

Another distinction between systems concerns the variability of the space between the rollers. Dry granulators with a variable gap are preferable as only they can ensure a consistent granule porosity at a constant compaction pressure, thereby guaranteeing reproducible production conditions for slugs. During the continuous monitoring of the process, a reference value comparing actual and target gap size is generated. The goal is to maintain a parallel gap between the rollers so that the slugs exiting the process exhibit identical characteristics throughout the entire lot.

The rotation of the feeding screw is in a control loop with the gap adjustment. This means that as the gap widens, less material is fed into the gap by the feeding screw so that the gap will close again. Due to this automated feedback control, the slugs are produced with a defined thickness and porosity.

With the BRC series, Bohle combines high production capacity with minimal material loss. Drive generation occurs purely electromechanically, in contrast to the competitors’ models. This ensures consistent slug characteristics. An electromechanical drive system avoids the disadvantages of hydraulic pressure regulation such as the need to replace old oil and valves, temperature excursions and contamination of the oil. This highly precise process is supported by the incorporation of pressure sensors located directly at the site of energy transfer and thereby capable of measuring the pressure directly. The results are more accurate than in hydraulic arrangements, whereby pressure values are generally arrived through calculation.

The BRC regulates the compaction energy and slug thickness in an innovative way and generates a consistent compacting of the material throughout a range of < 1 - 400 kg/h. Meanwhile, the advanced design of the unit simplifies handling and shortens the fitting procedure.

The “Hygenic Design” and already as standard integrated washing nozzles guarantee an effective WIP process with a residue-free removal of the product. The compactor also meets “Quality by Design” requirements with its functional GMP-tailored construction and the option of implementing PAT-tools.

Besides influencing the compacting energy of the unit, the milling step has a substantial impact on the particle size of the granule. Milling the slugs into a granule with the desired range of particle dimensions is performed by the conical Bohle Conical Mill (BTS) and sieve inserts with very little waste – even at a high throughput rate. Every BRC can be re-fitted in a matter of minutes to serve as an alternative rotational sieve and adapted flexibly to the process and slug conditions.

An important and substantial advantage of roller compactors is their small footprint and easy integration into the production process. Bohle has installed numerous BRC units in various production scenarios (stand-alone unit, wall installments, stage and multi-floor applications as well as individual containment applications) working with both batch and continuous manufacturing concepts.

T

he pharma industry operates at the sensitive intersection between medicine and money. While pharmaceutical products save countless lives every year around the world, an array of controversies – ranging from opioid addiction crises and product safety issues to allegations of anti-competitive industry collusion – have cast a shadow of suspicion over the entire sector.

In most polls gauging the public’s perception of various industry sectors, pharma can be found hovering at or near the bottom of the table. In the US, where privatised healthcare and insurance premiums have put patients at the sharp end of complex and sometimes brutal market dynamics, public views towards drugmakers could scarcely be dimmer.

In Gallup’s latest Work and Education poll released in September, the pharmaceutical industry ranked dead-last among all major industries based on public attitudes. Around 58% of Americans had a negative view of the industry, while just 27% felt positive about the sector.

To some extent, the nature of the pharmaceutical industry’s work has always provoked strong feelings and drawn stern criticism. But with high-profile political figures like Bernie Sanders and Elizabeth Warren taking Big Pharma to task while campaigning for the Democratic nomination in 2020, there has never been such tension around the industry, and especially its pricing.

“Pharmaceuticals are the only product that people believe they are entitled to,” says Eric Dezenhall, CEO of Washington DC-based crisis management firm Dezenhall Resources, which specialises in shepherding its clients through public relations disasters. “It’s an extension of health, so there’s a sense that I am owed my health, why should I have to pay for it? So much of my business, I see people who are angry with companies about their products. That’s not the case here. People really want pharmaceutical products – they just don’t want to pay for them.”

To put it mildly, the pharma industry has a difficult task in the field of PR. With complex science and economics to discuss with a highly sceptical audience, not to mention the whirlpool of information (and misinformation) that is social media in the 21^st century, the challenge of effectively promoting new treatments while warding off potentially ruinous criticism is extreme.

“One of the challenges is that healthcare companies now have to sell more than the product,” says Philip Lucas, medical writer at Inklab Medical Communications, a healthcare PR agency with offices in Dublin and Belfast. “So communicators like myself must show that the industry is building and creating solutions that are beyond just a tablet or a pill.”

For everyday communications, such as relaying trial results or extolling the clinical benefits of a novel therapy, one of the most obvious keys to effective marketing is to identify the intended audience and tailor communications to their level of expertise and media consumption habits, which will differ widely between, say, pharma’s traditional expert audience or the general public.

“I think that’s really key to producing good communications pieces, in terms of how they consume information, demographics, age, sex,” says Lucas. “That will allow you to effectively choose the channels you use. The main issue sometimes is just not knowing the target audience, and not tailoring the message to the audience. I’ve seen some companies have reproduced quite complex data and sent it out into the public domain, where I think it will just fall on deaf ears.”

Pharma firms routinely contract external PR agencies like Inklab to supplement their own communications departments and support the rollout of key strategic messages. For Chad Hyett, executive vice-president at New Jersey-based medical PR firm MCS Healthcare Public Relations, setting the right tone between a pharma client and their agency is vital.

“We need to be fully on-site with the clients,” he says. “Some clients love that, and other clients are resistant but they come around to it. We are at the table and we make that expectation very clear upfront, because otherwise that’s how you lose clients. You’re not connected to the broader team and you don’t understand the broader vision and you don’t immerse yourself in their business. You become a vendor rather than a partner.”

The rise of social media has had a massive impact on the nature of corporate messaging, turning one-way communications into an open discussion. Pharma, like many highly regulated industries, has been wary of engaging with a potentially hostile audience in the uncontrolled and highly public battlegrounds of Facebook and Twitter. Nevertheless, the social media horse has already bolted, and there’s no use closing the stable door now. The dilemma for drugmakers has become how to use these platforms, and who to engage.

“People want to hear back from a pharma company on social media, just like they want to hear back from [fast food chain] Wendy’s,” says Hyett. “We’ve failed to put the mechanisms in place, and it’s all risk-driven. But there’s a pathway and I think some companies are getting a little better at doing that.”

It’s also about having clarity on the objective of digital communications within the social media landscape. Hyett notes that social media exchanges are best suited to listening to customers rather than simply promoting your product, and striking the right chord with patients can lead to benefits in research. Finding and retaining clinical trial participants is one of the industry’s most persistent problems, and it’s an area where effective communications can be a great help.

“If you can communicate effectively to patient groups or the public, you’ll get a better response, greater patient insights, and the opportunity to collaborate with patients and patient organisations in a transparent and ethical way,” Lucas says. “In the long term, this will lead to better trials, I think, and better patient outcomes.”

In terms of knowing your audience, patient advocacy groups have an increasingly powerful voice in the sector, and offer the prospect of genuinely productive collaboration with patients and caregivers in the appropriate disease areas. Pharma companies have long been prolific financial donors to patient organisations, but Hyett argues these relationships should be more open and less transactional.

“What I often hear from advocacy groups is that companies come in and they ask the patient advocacy groups, ‘How can you help me with my product or my messages?’” he says. “I think advocacy groups want more mutual collaboration here. There’s a lot to learn from each other, and collaborating to help [patients] needs to be the mindset, not how can we use patient advocacy groups as a channel.”

Of course, in the event of a major controversy or public relations crisis, peacetime practices tend to fall by the wayside in favour of whatever measures can reduce a company’s exposure to public opprobrium.

Dezenhall has worked in crisis management for more than three decades, and while he refuses to reveal contracts, the firm reportedly counts the likes of ExxonMobil, Michael Jackson’s legal team and pharma giant Eli Lilly among its past clients.

Recently-revealed bankruptcy documents from Purdue Pharma, which went bust in September after being implicated in the escalating US opioid addiction epidemic, reportedly also showed that the company has worked with Dezenhall Resources.

Dezenhall’s thinking contradicts many of the more sensitive views of his counterparts in PR, which should come as little surprise for a man who has been described as the ‘pit bull of public relations’, and whose role is more to do with damage limitation than bridge-building. In fact, Dezenhall doesn’t even see crisis management as part of the same field as PR communications.

“I don’t believe [crisis management] belongs in the PR industry; I believe it’s some combination of management consulting, journalism and psychiatry,” he says with a wry chuckle.

He sees dealing with a reputational crisis as closer to a political campaign than an ad campaign, and notes that executives often aren’t ready for the stark choices that must be made in the event of a sudden controversy, justified or not.

“There is a tendency to view crises as communications problems rather than conflicts,” he says. “I look at them as conflicts. I don’t think there are many misunderstandings here. I think these are fundamental conflicts that a lot of industries try to medicate as if they are just some misunderstanding.

“I always say to a client, ‘What do you want? Is the goal justice, revenge, money, to be loved?’ I think a lot of times clients want to be loved when I don’t think that’s really on the table. I think for the pharma industry, what you really want is to be attacked less, as opposed to being loved. I just don’t think being loved is going to happen until you start giving away your product for free and guaranteeing a 100% chance of success.”

Similarly, Dezenhall describes exhaustive preparation as something the PR industry recommends “because they get to bill for it”, and while other PRs champion social media as a powerful tool for healthcare engagement, in a crisis he rejects such platforms for their volatility.

“Five years ago, any millennial wearing rectangular glasses who used the term social media was hailed as a genius,” Dezenhall says. “Now what I’m seeing is top executives calling me privately into their offices, shutting the door and saying, ‘This stuff may actually be the problem.’”

So what broad strategy does Dezenhall recommend for pharma companies in the midst of a PR crisis? The answer cleaves close to the traditional communications tenet of knowing your audience.

“I think the industry needs to think less about its reputation writ large, and more about all of the sub-audiences that it cares about,” he says. “What can be better is targeted communications designed to help you be attacked somewhat less. That’s actually more effective because it’s harder to attack someone you’ve been communicating with. But that’s not a very glamorous proposition. What most people want to hear is, ‘Let’s spend $70m on an ad campaign with little girls and puppy dogs'. Everybody just feels so good about it that nobody ever asks the question, is it effective?”

In the age of big data, Dezenhall also emphasises the merits of presenting a human face in times of crisis.

“I’ve got to tell you, the biggest problem I’ve had with pharma companies is finding an actual person who, in times of controversy, will actually dive in front of a camera and do combat if necessary. I think what happens is the individuals keep saying, ‘What’s in it for me to go on camera in the middle of a controversy?’ And that’s true because whoever goes on TV has a career problem. But people don’t want to see data, they want to see people. I’ve really had a problem with this, not just with pharma but with multiple industries – where are the human beings?”