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Enteric coated tablets formulation Equipment

Formulation technologies are an integral process in many industries such as pharma and food. Chemical mixtures require strict handling to combine the separate ingredients into the homogenized recipe that makes your final product. Formulation technology stores, mixes and subjects the elements to a range processing parameters according to your specifications to develop the base material. The resulting formulas are then weighed, formed, packaged, or sent for further formulation.

Formulation

When taking a tablet, it is usually the job of our stomach to break down the medication to make it ready to be absorbed into the bloodstream. However, some drugs are not meant to be dissolved in the stomach because the acidic pH of the stomach can disintegrate the drug, making it no longer effective. Using tablet coating equipment that applies a polymer barrier to the tablet makes it possible to protect it from stomach acidity.

Enteric Coated Tablets

<span style="font-weight: 400;">For pilot and lab-scale pharmaceutical formulations, a high-shear granulation mixer is the perfect choice for cohesive materials. Traditional low shear mixers used in labs fail to process these materials due to higher amounts of hydrophilic polymer. A high-shear machine specifically designed and built for smaller scale operations will achieve optimum results at less cost.</span>
<h2>Value-for-money cGMP compliant small-scale pharmaceutical mixer/granulator</h2>
<span style="font-weight: 400;">The Sejong Pharmatech SM5C is an entry-level floor-standing mixer for pharmaceutical processes. cGMP compliant, the SM5C features digital controls and uses interchangeable mixing vessels for maximum flexibility.</span>

<span style="font-weight: 400;">Available in 1l, 3l and 5l batch versions, the SM5C is ideal for small scale production, pilot or lab work, and has been engineered to provide high quality particle agglomeration.</span>

<span style="font-weight: 400;">Fully mobile with built-in casters and able to run from a wide range of power supplies, the SM5C offers enhanced flexibility for the pharmaceutical industry.</span>

Entry-level high-shear mixer for drug formulation

<span style="font-weight: 400;">The efficient size reduction of granular powders is a key step in many pharmaceutical processes, and choosing the right equipment for your application can be vital. Conical mills offer excellent flexibility, as different forces can be achieved simply by changing the impeller type, and different particle sizes by changing the screen type.</span>
<h2>Highly flexible mill for a wide range of pharmaceutical powder preparations</h2>
<span style="font-weight: 400;">The Sejong Pharma CM Series of conical mills offers a range of milling head sizes to suit a variety of production volumes. Available in 500, 1000 and 2000 kg/hour versions, the CM Conical Mill is a fully portable mill, with electric height control allowing for operation into a range of output containers.</span>

<span style="font-weight: 400;">With easily interchangeable heads providing a wide variety of screen sizes and impeller variants, the CM series adds flexibility to your pharmaceutical powder production with reduced cost.</span>

<span style="font-weight: 400;">Easy to operate, with a simple electronic interface, the unit is also quickly and simply disassembled for cleaning thanks to a simple clamp action attachment system.</span>

Conical mill for drug formulation

<span style="font-weight: 400;">The ability to coat tablets in an even and controlled way is an important stage in the production of pharmaceutical doses. Layers can be aesthetic, protective, or active as part of the dose release mechanism. Large scale tablet coating machines are either inefficient or unsuitable when used in development or small batch production environments, where flexibility is a key requirement.</span>
<h2>Flexible tablet coater with advanced features for the development environment</h2>
<span style="font-weight: 400;">The Sejong Pharmatech C30FC automatic tablet coater has been developed specifically for the needs of R&amp;D, lab work and small scale production. With a flexible coating volume from 0.4 to 6.3l per batch and a small and portable form factor, the C30FC has features made to improve ease of use.</span>

<span style="font-weight: 400;">The C30FC features removable, fully perforated coating pans in mirror-finish 316L stainless to eliminate tablet sticking/clumping. Different pan designs allow for different volumes of tablets to achieve the perfect results. The low height of the machine means that removal and replacement is simple and only requires one operator and no additional equipment. All round observation windows make it easy to visually inspect the coating process throughout the cycle.</span>

<span style="font-weight: 400;">The built in spray gun has an easy set system with integrated measuring rule. This makes it very easy to set the correct spray position and head angle for each of the different coating pans.</span>

<span style="font-weight: 400;">As part of its standalone design, the C30FC features and electric heat exchanger, rather than relying on steam used in higher volume coaters. The unit also features a fully modular peristaltic pump for the coating solution, allowing for very simple maintenance, cleaning or repair.</span>

<span style="font-weight: 400;">The HMI graphical interface has been designed for ease of use and simplicity, and the whole system is fully 21CFR part 11 compliant.</span>

<span style="font-weight: 400;">Optional extras include companion stainless steel solution storage tank with heater element and a HEPA filtration system to allow maximum dust extraction or to handle hazardous product.</span>

Automatic tablet coater for lab scale

<span style="font-weight: 400;">Many pharmaceutical doses in tablet form require a coating before they are ready for use. These layers can be purely visual, providing a color difference, or may be based around sugars in order to increase palatability. Some coatings also have an active pharmaceutical property or can directly affect the means that the primary dose is released. For use in an R&amp;D situation, a full size coater is inefficient and too large to be viable. Smaller standalone jacketed coating machines offer a much more economical and efficient solution.</span>
<h2>Flexible tablet coater with advanced features for the development environment</h2>
<span style="font-weight: 400;">The Sejong Pharmatech C30JC automatic tablet coater has been designed to meet the needs of lab operations, research and development and small batch production of coated pharmaceutical tablets. Different pans allow for the accurate and uniform coating of as little as 0.4l and up to 6.3l per batch.</span>

<span style="font-weight: 400;">The pans for the C30JC are fully perforated and constructed of mirror-finish 316L stainless steel, which minimises any clumping or sticking. Different pan designs allow for different volumes of tablets to achieve the perfect results. The low height of the machine means that removal and replacement of the jacketed pans is simple and only requires one operator using the easy to operate lifting and removal unit supplied. </span>

<span style="font-weight: 400;">The built in coating spray unit is easy to set and features an integral measurement scale, making it simple to set the optimum position and angle of the spray head for each pan type.</span>

<span style="font-weight: 400;">Rather than relying on steam as found in larger scale coaters, the C30JC uses and efficient electric an electric heat exchanger that is able to run from a single phase supply for convenience. </span>

<span style="font-weight: 400;">The touchscreen interface has been designed for simplicity and clarity, and the whole system is fully 21CFR part 11 compliant.</span>

<span style="font-weight: 400;">Optional extras include companion stainless steel solution storage tank with heater element and a HEPA filtration system to allow maximum dust extraction or to handle hazardous product.</span>

Tablet auto coater for lab scale

<span style="font-weight: 400;">By employing a weight sorter that is fully flexible and able to handle a wide variety of dose shapes and sizes you can benefit from reduced equipment cost and improved production. Such flexibility without the requirement to change machine parts is now available for large scale production facilities.</span>
<h2>Easy to use, fully flexible weight sorter for large scale production</h2>
<span style="font-weight: 400;">The SADE SP440 from CI Precision is a highly accurate, easy to operate and fully flexible dosage weight sorter for use in larger-scale production environments. Featuring a single 150l hopper and 4 weighing channels for bulk operations at up to 22,000 units per hour and an easy-to-use operator interface, the SADE SP440 is accurate to within +/- 2mg.</span>

<span style="font-weight: 400;">Designed with flexibility in mind, the SADE SP440 can handle a wide range of tablets and capsules, switching between them with no requirement for changing physical parts to accommodate different dose types. The SADE is able to weigh tablets up to 20mm x 24mm, and capsules from 5 through to 00 size (larger sizes may be accommodated). The machine is also able to be quickly and easily dismantled for cleaning and sanitizing.</span>

<span style="font-weight: 400;">The unit has the ability to reclaim “good” product from a weight-rejected batch, saving valuable product and producing less waste. The unit records all sort operations and can print reports direct to a printer or send to a PC.</span>

High capacity weight sorter for tablets &amp; capsules

Tablet coating can be applied for adding colours or glosses, or based around sugar in order to increase palatability. Some coatings also increase stability where some have an active or functional pharmaceutical property and can directly affect the means that the primary dose is released. When used for development or small batch production, a full-size coater is too large to be feasible. You need a flexible solution to coat tablets in an even and controlled way.
<h2>Flexible tablet coater for research and development</h2>
The Laboratory Tablet Coater from Romaco Tecpharm is designed to produce the film coating of tablets or pellets, suitable in aqueous and organic coatings. It is important to optimise processes before industrialization. Therefore, to minimise time and cost risks, the tablet coater for laboratory scale is used for testing purposes prior to industrialization.

The equipment controls each critical variable, such as applied liquid flow, air flow, air temperature, tablet temperature during the process, and the turning speed of the pan drum,  which  ensures a state of balance between continuing processes. Being a R&amp;D equipment, controlling different variables allows you to decide changing which variable could best optimize your production process.

The standard equipment is suitable to work with interchangeable drums from 0.5 to 2 kg. With a perforated coating pan, the equipment allows different capacity to be processed without need to change the drum.

Tablet coater for laboratory scale

Pharmaceutical laboratories need compact equipment to handle and produce small amounts of granules from a mixture of wet and dry elements for R&amp;D applications. Furthermore, the granulation process requires short residence times in drying the products to easily identify and remove the defects without discarding the entire batch.


<h2>Automatic feeding, granulating, and quick drying of pharmaceutical  products</h2>
The QbCon 1 from L.B. Bohle is a continuous wet granulating and drying system for pharmaceutical laboratory scale applications. The system performs three processes: feeding, granulating, and drying. It features a twin screw granulator with a hinged barrel for easy access to its parts. The unit comes with a multi-position feeder and interchangeable ports, ensuring accurate gravimetric feeding of dry powder and using a pulsation-free pressurized feeder for granulation liquid.

The wet granules are gently dried by a moving fluid bed that provides short residence times and consistent product output. Its narrow residence time distribution allows easy traceability from the initial product to the final tablet or vice versa. The drying process parameters, such as airflow, temperature, and conveying speed, can be controlled and adjusted according to product requirements. The system allows for sampling wet and dry granulations without interrupting the ongoing processes. The system also has an innovative filter cleaning system to prevent clogging for longer hours of operation. The unit also features a complete WIP (Wash-in-Place) cleaning.

Continuous wet granulator and dryer for R&D

API making equipment must observe rigorous quality control standards across the entire manufacturing process. The pharmacodynamic properties of active pharmaceutical ingredients API make them highly sensitive to their environment, making API manufacturing and production a tightly regulated field.

Active pharmaceutical ingredients (API)

Microtablets range between 1 and 4 millimeters, making the dosage form an excellent delivery system in polypharmacy. The size of the products makes them easier pills to swallow, but microtablets production brings a unique set of complexities.

Microtablets

L.B. Bohle is a technology leader in machines, systems and processes for the pharmaceutical, chemical, food and nutraceutical industries. Our focus is on equipment for tablet manufacturing.

Continuous wet granulation and drying have been widely discussed in pharmaceutical research and development (R&amp;D) and industry. Daniel Emanuele from the Dortmund University of Applied Sciences and Robin Meier from L.B. Bohle set out to test if the QbCon® 1 from L.B. Bohle is suitable for extended process times and meets the quality standards of the market.


<h2>The research zoomed into three metrics</h2>
The research focused on measuring moisture content, residence time distribution, and granule size distribution of the granulator and dryer. The results indicate that the dryer achieves very precise and consistent residence time distributions, resulting in uniform drying of granules across different size categories. The process consistently produces granules with the desired moisture content and particle size over extended periods. By adjusting the conveying speed of the granules in the dryer while keeping other parameters constant, the researchers were able to determine the limits for specific process/formulation combinations, primarily influenced by the depth of the fluid bed.

The ability to monitor the process in real time makes the QbCon® 1 an ideal choice for introducing continuous wet granulation, especially with its innovative drying process.

See it in the video!

[embed]https://youtu.be/XRyCPRNM9jE[/embed]

&nbsp;

Scientifically tested continuous drying for your tablets

Pharmaceutical

Pharmaceutical powders provide longer shelf life and better stability than liquid dosage forms. But the processing of pharmaceutical powders is crucial for growing segments besides pharmacy. Functional foods and cosmetics formulated with active ingredients and excipients depend on powdered forms to fulfill their promises.

Pharmaceutical powder

Pharmaceutical developments walk side by side with health advances to provide new medicines, treatments, and therapies that have increased life quality and extended life expectancy by years. Pharmaceutical manufacturing equipment helps deliver products to a great deal of the population, but there’s a significant share that doesn’t benefit from them yet. Over 2 billion people cannot get the medicines they need, according to the United Nations Industrial Development Organization, and local production might be a way to provide for these people.

Pharmaceuticals

Among all dosage forms in use today, tablets constitute the most common one. They are pharmaceutical solid dosage forms containing active ingredients and excipients such as diluents, binders, glidants, and lubricants. Using tablet making equipment, these solid dosage forms are made by compression of granules or powder blends and then shaped by molding.

Tablets

In pharmaceutical industries, where large-volume production is the norm, compactors or granulators are used to turn powdered materials into granules. As hydraulic systems are commonly utilized in these granulators, the compressibility is affected by the properties of the oil used. Certain oils can be compressed more than others and their properties degrade over time and are affected by temperature fluctuations.


<h2>Compacting dry powder into granules using an electromechanical roller drive</h2>
The Dry Granulator BRC 100 from L.B. Bohle, is a compacting system that turns powdered materials into granules for pharmaceutical industry applications. The system utilizes an electromechanical roller drive to provide precise control, consistent compressibility, and minimal material loss compared to hydraulic systems that rely on oil properties to drive the rollers.

This setup offers less maintenance as it does not require oil changes and an oil cooling system. The system has a flexible sieve setup allowing for the use of either a conical sieve or an oscillating sieve to obtain the desired granule size of the product coming out from the rollers. The granulator comes standard with integrated WIP (Washing in Place) nozzles for effective and easy cleaning. The entire system can be assembled or disassembled quickly, which helps improve maintenance and installation.

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Dry granulator for pharmaceutical powders

Chewable tablets are suitable for patients who have difficulty swallowing. Chewable tablet formulation masks the natural flavors of pharma drugs and alters their aftertaste. But besides the taste, chewable tablets favor the bioavailability of pharmaceutical ingredients.

Chewable tablets

Pharmaceutical innovations, particularly with highly potent active ingredients (HPAIs), are thriving largely in oncology medication. However, ensuring safety for both operators and patients is paramount. L.B. Bohle has sought to make sure that your medicine comes with the highest quality and that your operators stay safe during the dry granulation process.


<h2>Safe production = safe medicine</h2>
If we look at pharmaceutical production at containment level OEB 5, which has high potency and toxicity, you must make sure that there is absolutely no direct contact between your operators and the medical substances.  L.B. Bohle has tackled the concerns and can integrate them within their BRC dry granulators. Features such as glove boxes for safe handling and an integrated isolator unit in the compacting unit comply with manufacturing guidelines while prioritizing safety and efficiency.

The granulators have a containment port underneath the sieve unit for the removal of granules and a containment port for flake sample collection. You can also remove the product from inside the granulator residue-free with integrated WIP equipment.

Are you eager to learn more? <a href="https://lbbohle.com/pharma-whitepaper-pharma-product-brochures">Bring yourself up to speed with the whitepapers from L.B. Bohle.</a>

Aim your safety standards high, while granulating dry

Manufacturing pharmaceutical solids like tablets requires using a proper blender to blend dry powders into a homogenous mixture. Having a blender that can accommodate various blending container sizes allows easy adjustment of the production volume.


<h3>Blending homogenously dry powder batches using a stationary blending device</h3>
The Container Blenders PM from Bohle is a blending system for fine solids and powders in pharmaceutical applications. The system features a wide variety of blending containers with various capacities that can handle square or round containers. Each blending container can be used to mix powders effectively at a range between 20% to 85% of its total container volume for densities ranging from 0.2 to 1.2 kg/L. The blending process is done in a closed system; each container has an inner lid for filling.

The blending system rotates at 6 rpm with an option to increase the speed depending on process requirements. It can be equipped with a chopper that operates at a speed of approximately 750 rpm to break solid lumps and chop small amounts of ingredients.

Product changeover can be done quickly by simply exchanging the blending container. The entire system can also be used as a milling station for bin-to-bin product transfer.

Container blender for pharmaceuticals

Multilayer tablets are a popular fixed-dose combination (FDC) offering a range of release profiles for effective drug delivery. Multilayer tablet technology solves challenges to API consistency, allowing manufacturers to develop formulations from incompatible ingredients while optimizing the release profile for immediate release and controlled release.

Multi-layer tablets

Whether you are making pharmaceuticals, chemicals, or nutraceuticals, you will need to blend your ingredients. Depending on your product and production needs, finding a suitable blender is the utmost priority, but it can prove to be a challenge. L.B. Bohle has tackled the need and come out with a wide array of blenders, adjustable for your processing needs and goals.


<h2>Five solutions to fit your needs</h2>
Their portfolio of blenders can be scaled up to 12,000 liters with standard exchangeable containers up to 2,400 liters. You can choose from five different pick-up systems.

First, you can request standard load arm and clamps, with containers docked using electronically monitored quick clamps for your blender. In this solution containers up to 1,200 liters, mounted on an undercarriage, can be adapted without additional lifting equipment. Additionally, you can opt for a chopper installation whose drive is integrated into the load arm.

Secondly, you can request a blender version where the system can be swiveled around its vertical axis. This design comes with a huge advantage: long service life and extremely low maintenance requirements!

Did this spark your interest and are you curious to find out about the other systems? <a href="https://lbbohle.com/pharma-whitepaper-pharma-product-brochures">Read more on the whitepapers from the L.B. Bohle team.</a>

Discover the best mix for your blending application

Chemical

Due to their potential hazardous nature, chemicals are classified for proper identification and safety during production. Chemical classification depends on their properties, structures and functions. In the chemical industry, you can regard them as basic chemicals such as acids, chemical products to produce plastic materials and finished chemicals for use in cosmetology. As a manufacturer or engineer, you want to know their reactivity when using chemical processing equipment.

Chemicals

Eating is more than just nutrition, but we have found ways to increase the nourishing power of our foods. Nutraceuticals manufacturing, from vitamin C powder and probiotics to omega 3 oil, is a concentration of natural ingredients and health supplements that complement our diets. While dietary supplements are not quite haute cuisine, the process of extraction and purification is no less a blend of science and art.

Nutraceuticals

Tablet coating involves applying a thin layer of coating material to pharmaceutical tablets, which requires controlled temperature, humidity, and air quality. This process typically consumes significant energy and contributes to high costs and environmental impact. To address this, an advanced energy monitoring system can be integrated into your coater for a more sustainable process. Additionally, by implementing heat recovery in the ventilation system, the excess heat generated can be captured and repurposed, reducing waste.


<h2>Evenly coat your tablets using automatic and adjustable spray nozzles</h2>
The BFC 400 from L.B. Bohle is a film coater equipped with 8 adjustable spray nozzles inside a long drum with patented helical baffles. The tablets are sprayed on a flat tablet bed while mixed gently and thoroughly by the helical baffles, which helps prevent the products from twinning. The system’s controlled air movement allows for improved coating structure of the tablets with minimal spray and suspension losses.

The system comes with an iFix control system featuring a large sight glass and a small nozzle arm for good visibility of the coating process. The machine allows fully automatic sampling and feeding even with the door closed for additional safety features. The system can be rapidly discharged by reversing the rotational direction of the pan and by tilting. The machine is also equipped with a CIP system for easy cleaning. A cleaning lance is provided at the bottom of the unit and an enlarged drain pipe allows quick draining of cleaning agents without leaving residues. Optional features include integrated energy control and heat recovery in the ventilation system for a more sustainable operation.

Energy-efficient film coating machine for pharmaceutical tablets

While coating your tablets, uniformity is the key aspect to keep in mind, since uneven coating could yield a huge loss in your production line. We had a chance to see L.B. Bohle's innovations up close, and we can tell you that you can leave all unevenly coated tablets in the past.


<h2>Achieve a larger spray area with an increased spray rate</h2>
L.B. Bohle has put the innovations into practice with the BFC tablet coater series. The drum geometry of the coater has a large spray area within the moving tablet bed, which allows for the utilization of more spray nozzles compared to shorter drums. Therefore you will have a larger total spray area and increased spray rate.

L.B. Bohle offers various solutions for adjusting the distance between the nozzle bed, the spray angle of the nozzles, and the pressure parameters for atomization. Typically, the amount of suspension mass in film-coated tablets ranges from 5% to 15% of the core mass. The film thickness is especially critical if you are making tablets with active ingredient coatings and thin-color (protective) coatings.

See for yourself in the video below!

[embed]https://youtu.be/GSDL1A19Va0[/embed]

Coat-astrophe averted: a sprightly spin on tablet efficiency

When making pharmaceutical tablets and coating them it's pivotal to get all your tablets out of the coater fast and clean the equipment for upcoming batches. L.B. Bohle has come up with a solution that enhances the process.


<h2>Turn your head towards the end of the coating</h2>
Not only have they perfected the coating process, but also the discharging after the coating is done. Therefore, you can discharge your tablets from the coater by reversing its rotation and adjusting its inclination. Thus the coater is tilted and you can get your products out quicker and easier. This step is followed by fully automated cleaning.

Additionally, L.B. Bohle has integrated an extra cleaning lance at the unit's base as a standard feature. Compared to prior technology, the cleaning time is now shorter and ensures that the cleaning solution drains away rapidly and completely, leaving no residue.

Watch the video to see how the discharging process on the BFC 400 works!

[embed]https://youtu.be/vhgV0pfOz9A[/embed]

Lean into efficiency with inclined tablet discharging

Producing the finest micro-emulsions and suspensions requires a mixing machine that generates extremely high shear.  Multi-staged rotor/stator dispersing machines work well for this purpose because of the high shear forces applied to the mixture at each rotor/stator stage.  A rotor /stator dispersing machine that also incorporates extremely fast rotation and resultant tip speeds for even greater shearing action will lead to the creation of super-fine emulsions and ensure the success of your process.
<h2>Top-of-the-line rotor/stator dispersion with utlra high shear for nano-scale particle emulsions and suspensions</h2>
The DISPAX-REACTOR® DRS from IKA is an inline ultra high shear dispersing machine used to achieve the finest micro-emulsions and suspensions. Extremely high shear rates (up to 190.000 1/s) combined with a fine generator geometry enable crushing of droplets and solids particles down to the nanoscale. The resulting product has long-term stability which reduces the need for emulsifying agents and thickeners. Because of the extremely high energy density, other dispersing aids can be reduced or possibly eliminated.

The DRS is usually equipped with a two-stage rotor-stator system (generators). The high tip speed of 40 m/s (10.000 fpm) often negates the need for a third stage. The ultra-fine dispersing machine, designed with the same high quality features as the ULTRA-TURRAX® UTL and the DISPAX-REACTOR® DR, is especially well suited for challenging pharmaceutical applications.  The units are designed for easy and reliable scalability and sizes are available with flow rates from 70 to 40.000 liters per hour.

Ultra-fine dispersing machine for emulsions and suspensions

Used in the pharmaceutical industry to produce tablets and capsules, among others, pharmaceutical granules are made to enhance the uniformity and flow of powder, increase the density of the blend and reduce dust and, therefore, toxic exposure. The choice of the granulation process, whether it is wet, dry, or direct compression, as well as the selection of appropriate pharmaceutical granulation equipment, depends on the specific drug being formulated.

Pharmaceutical granules

Built upon its world-leading laboratory equipment, IKA Process is a game changing manufacturer of dispersing machines, homogenizers, stirrers, jet flow agitators, and kneading machines.

In the pharmaceutical industry, change often moves at a snail’s pace due to stringent regulations, but it does happen.



Traditionally, API manufacturers relied on the dry milling process, which begins with crystallization or precipitation within a liquid medium, where crystals form and grow. These crystals are separated using a centrifuge, dried, and finally subjected to dry milling before tableting.

As APIs became more potent, dry handling became problematic due to dust generation, causing cleaning issues and product loss. Furthermore, stricter ATEX regulations for handling hazardous powders have expedited the demand for change.

It’s not as simple as just mixing dry ingredients together, and voila, you have your API. APIs are always, and I mean always, synthesized within a liquid medium to form solid crystals. If liquid is always a part of the equation, why not control the growth of those crystals already in the crystallization step?

And this is where wet milling came into play. This approach allows early particle size control during precipitation, enhancing pharmaceutical manufacturers’ control over the API’s final particle size and distribution.
<h2>“<em>The value of an idea lies in the using of it</em>.” – The benefit of early particle size reduction</h2>
We had a chance to speak with Werner Kanzinger, <a href="https://www.ikaprocess.com/en/Products/Process-plants-cph-18/?gclid=Cj0KCQjwmICoBhDxARIsABXkXlLSTjoDkEyEOxqysB6am7wNW99asG4jDKpXJpsQO5pzSj_wv8ZdyHYaAlsvEALw_wcB">IKA</a> Vice President, one of the first to use wet milling for API production. Creating new pharmaceuticals requires starting from scratch and developing principles in the R&amp;D world. To address this need, IKA introduced an innovative three-stage inline dispersing technology called the <a href="https://www.ikaprocess.com/en/Products/Pilot-plants-cph-40/magic-LAB-csb-MLAB/">Magic Lab</a>.

“<em>We knocked on every door in the R&amp;D world and were surprised how the technology was well-received. The industry recognized its</em><em> potential to simplify production through early-stage particle size reduction,” </em>Werner explains.

According to Werner: “<em>Even at a half-liter batch, APIs are very valuable and pricey. As production scales up to 1000 liters per batch, the cost can be over 1 million, and nobody wants to take any risk.”</em>

To serve the industry across diverse production scales, IKA replicated Magic Lab’s success on a larger scale, ensuring consistent milling outcomes without compromising quality.
<h2>No dust, no fuss - Wet milling is here to simplify your life by shortening your production time</h2>
In dry milling, solid materials undergo high-speed impact and shearing forces, generating airborne dust particles. This dust settles on equipment, necessitating extensive cleaning to prevent cross-contamination.

“A w<em>et mill is already designed to create a high-turbulence environment, which helps with dust reduction</em>,” Werner continues.

Additionally, wet mills are easier to clean than dry mills due to their smaller and less complex internals, requiring less time and effort. Operating already during the crystallization step, wet milling allows for localized energy application. This reduces energy consumption compared to drum mills.

“<em>IKA three-stage inline technology allows for complete drainage after use. The product flows from the top to the bottom through a three-stage rotor-stator, progressively reducing particle size from coarse to fine. Since it’s vertically installed, no product remains inside, making cleaning straightforward,</em>” Werner concludes.

Just remember, it is better to move forward at a snail’s pace than backward at any pace.

Wet milling: The revolution in the API production

Biopharmaceuticals are drugs in which the active substance is manufactured or extracted from biological origin materials. They are usually produced in bioreactors by plant cells, microbial cells, yeast cultures, or mammalian cells. Also known as biomanufacturing, they are used to either treat or diagnose and prevent a patient’s medical condition or disease. Biopharmaceuticals are typically complex macromolecules administered by injection or infusions, and examples include vaccines, serums, and insulin.

Biopharmaceuticals

The most important part of a capsule is its contents. But if the shell is not carefully made, the dosage ingredients inside lose effectiveness. From molding to sizing, capsule manufacturing equipment forms perfectly-matching husks ready for filling. The simplicity of encapsulation revolutionized pharmaceuticals since it was introduced in the 19<sup>th</sup> century. However, capsules are changing to increase delivery efficiency and reduce the dependency on gelatin.

Capsules

<p class="filterable-grid__description">Liquid dosage forms are designed for easy absorption. The body quickly carries the active ingredients through the system and triggers the required response. But the greatest advantage of this medicinal type is its flexibility in formulation and dispensation. From lotions and syrups to drops and sprays, liquid solutions can be adapted to different administration routes including parenteral, topical, and oral. The fundamental liquid dosage manufacturing process involves dissolving or suspending solutes in a fluid. But that is not enough. A precise blend of excipients is needed to make the medicine go down.</p>

Liquid dosage forms

The building blocks of matter have driven the imagination of philosophers, scientists, and artists for millennia. But, for manufacturers, these elements have a more concrete existence as powders. Powder processing technology conditions these primary materials to create a vast range of products, from chemicals and foods to pharmaceuticals and ceramics.

Powder

Tablet coating requires spraying, mixing, and drying procedures that must be carried out simultaneously under strict conditions to maintain the coating's stability. For a high-quality result, liquid coatings must be applied uniformly to every tablet to protect them from light and moisture.
<h3>Spray, mix, and dry tablets quickly and evenly</h3>
The Tablet Coaters BTC from Bohle is a system that combines mixing, spraying, and drying, to produce uniformly coated tablets. The system consists of a flat tablet bed with a long pan that sprays the tablets while being mixed carefully and continuously by helical baffles. The systematic forced guidance in the pan keeps the load in constant motion, preventing twinning and loss of solids and coating. Thanks to the elongated pan, the flat tablet bed allows minimum static pressure, which helps prevent the tablets’ breakage.

Emptying the system can be done quickly by reversing the rotational direction of the pan. Air is supplied and exhausted through the perforated pan to quickly dry the spray-coated tablets. The system is equipped with a multi-panel display for operation controls and can be integrated with CIP system.

Pharmaceutical tablet coating machine

Who knew that dragee and tablet making had something in common?

The sweet connection to the pharmaceutical world lies in the art of coating, which has its roots in the confectionery industry. Both dragee and tablet coating involves the application of a layer of material – sugar for dragee and a polymer film for tablets - around a core, be it a nut or a drug substance.

But as you may know, in the pharmaceutical industry, rules and regulations are kings. According to the pharmacopeias, coated tablets must pass the test on uniformity of dosage units. Obtaining a uniform coating across all tablets in a batch may seem simple, but it is actually a complex process involving spraying, mixing, and drying.


<h2>Can you guess what might cause tablet coatings to be uneven?</h2>
How about improper mixing, inconsistent drying, or poor atomization? All those factors can cause uneven coating thickness…and that’s where the coater design comes in.

For instance, a pan with a small bed surface may not provide enough space for the tablets to move freely, causing uneven coating distribution. Or if the tablet bed is not flat, this can lead to tablets accumulating in the center or on the sides of the pan.

If the baffles are not properly designed, they can cause dead spots that the coating solution may not be able to reach. In addition, the number of nozzles and nozzle-to-nozzle distance can lead to areas of undercoating or overcoating.
<h2>Good things come in threes.</h2>
We talked with <a href="https://lbbohle.com/" target="_blank" rel="noopener">L.B. Bohle</a>'s technology expert, Tobias Borgers, on the ins and outs of their coating machine, and what makes it stand out in the industry.

“<em>Bohle technology contains three unique design principles which assure a good coating uniformity,</em>” explains Tobias.

First, the pan geometry provides a large tablet bed surface which allows the incorporation of a high number of spray guns, resulting in time savings of up to 40% during the coating process.

Second, helical baffles offer continuous and homogenous axial mixing within the tablet bed, preventing the formation of dead zones and minimizing tablet damage or twinning by avoiding acceleration peaks.

Third, the air principle allows for drying to occur within the tablet bed while keeping the rest of the coater and the spray guns cool.

“<em>In this way, spray losses are reduced to a minimum which leads to coating efficiencies of &gt;95%,”  </em>Tobias concludes.

Remember, coating isn’t just for candies. However, while an uneven coating on candy may only result in an unpleasant look and taste, a poorly coated pharmaceutical tablet can severely affect the patient's health.

The sweet world of pharmaceutical tablets - The trifecta for achieving coating uniformity

The billions of microbes living in our gut have a significant impact on gastrointestinal health, mood, and behavior. Every individual develops their microbiome community. Probiotic processing technology makes sure that harmful bacteria never outnumber good citizens.

Probiotics

The fizz of effervescent tablets is commonly associated with a vitamin C boost. But the soluble pill is an excellent drug delivery method for pediatric and geriatric patients. Sometimes referred to as carbon tablets, manufacturing effervescent tablets binds biocarbonate and citric acid that produce the smooth hiss as they dissolve in liquid.

Effervescent tablets

The two-piece capsule is a visual shorthand for all types of medical remedies. Advances in technology have made the production of hard-gelatin capsules a convenient delivery method for drugs and other ingested substances. But the simple solution requires micrometric precision to be manufactured to the proper pharmaceutical standards.

Hard gelatin capsules

Softgel capsules fast-track the delivery of medication to the bloodstream. Unlike solid pills, they do not need to be broken down by the body before the drugs can be absorbed. Moreover, they are optimal vehicles for oils and fat-soluble formulations that cannot be compressed into tablets.

Softgel capsules

The nonproprietary name for HPMC – hydroxypropyl methylcellulose – is such a mouthful that it has two abbreviations. Hypromellose is the other one. The non-ionized material offers a safe alternative to gelatin capsules, especially as most common API and excipients are suitable HPMC capsule ingredients.

HPMC capsules

Making.com is a new online platform that helps makers find production technology quicker by grouping it around the products they make.

What's new in pharmaceutical packaging?



During <a href="https://www.pharmapackeurope.com/en/home.html" target="_blank" rel="noopener">Pharmapack</a>, we met Chantal Younes, Key Account Manager at <a href="https://www.csptechnologies.com/" target="_blank" rel="noopener">Aptar CSP Technology</a>, who introduced us to the world of active packaging.

The pharmaceutical industry is subject to strict regulations, so that's why manufacturers are very meticulous when formulating their products but especially about their packaging, which must keep their products safe. Due to the formulation or active ingredient, pharmaceutical products can present significant stability issues if they come in contact with moisture or oxygen.

This is where Aptar CSP Technology comes in. Aptar CSP Technology has developed several active packaging solutions to protect pharmaceutical products and ensure extended shelf life.

The company has developed a new class of highly engineered polymer compounds that protect drug products, probiotics, and drug delivery systems from impurities, oxygen, and moisture. The polymer can be extruded into a film, injection molded, or blow molded.

#Changemaker: Ready to protect your pharmaceutical products from moisture?

Parenteral preparations refer to drugs using non-oral means of administration. Injectables, such as needles and syringes, are used to deliver a drug into the systemic circulation directly in the veins, muscles, under the skin, or in the tissue.

These parenteral formulations are pharmaceutical dosage forms that have strict regulations on being sterile, pyrogen-free, and free from visible particulate matter including reconstituted sterile powders. Solutions, suspensions, emulsions, and gels with APIs intended for administration by injection are usually supplied in vials, ampoules, pre-filled syringes, or pens to facilitate ease of use.

Injectables

It is strange how two tablets can belong to the same but at the same time to a different category depending on how the tablet itself is classified. For example, chewable tablets and effervescent tablets have two different routes of administration but both belong to the category of uncoated tablets. Uncoated tablets are prepared by compression of granules in which no coating is added after compression. They may be single-layer or multi-layer tablets.

Uncoated tablets

Did I take my medicine this morning or not?

Let's be honest. How often have we asked ourselves this question and failed to find an answer simply because… our memory sometimes doesn’t serve us right!

&nbsp;

Coming to the rescue of patients who need to keep track of their chronic medication and adhere to their daily treatment plan is FebriSol, a scratch-card calendar developed by Studio Fundi.

At <a href="https://www.pharmapackeurope.com/en/home.html" target="_blank" rel="noopener">Pharmapack</a>, we had the pleasure of meeting Ricky Stoch, the founder of <a href="https://studiofundi.com/" target="_blank" rel="noopener">Studio Fundi</a>, who showed us how simple it is to use FebriSol.

All the patient has to do is scratch off the day’s metallic coating that will reveal the check mark after taking the pill.

Current solutions for daily tracking are inconvenient and expensive.  FebriSol is a low-cost alternative that can help you keep track of your medicine every day.

#Changemaker: Keep track of your medicine every day with FabriSol sticker

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Enteric coated tablets formulation Equipment

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Entry-level high-shear mixer for drug formulation

Conical mill for drug formulation

Automatic tablet coater for lab scale

Tablet auto coater for lab scale

High capacity weight sorter for tablets & capsules

Tablet coater for laboratory scale

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Which enteric coated tablets formulation technology do you need?

Entry-level high-shear mixer for drug formulation

Conical mill for drug formulation

Automatic tablet coater for lab scale

Tablet auto coater for lab scale

High capacity weight sorter for tablets &amp; capsules

Tablet coater for laboratory scale

There is currently no equipment listed with your specified properties, but we are sure we can help you. Try us!Contact us

Let's talk about your project!

High capacity weight sorter for tablets & capsules