Multilayer Bead Manufacturing

Creating a final product with multiple coat layers can make for many advantages over a single-layer bead product. In many cases, the numerous layers are used to separate release profiles within the product so it is possible to specifically target release locations to enhance drug efficacy or reduce potential drug side effects without the modified release profiles interacting with one another. Other purposes could include improving solubility or providing protection against the environment. At Coating Place, we can place numerous layers onto a single core, which may act as separating layers, stability layers or contain the API itself. This creates the opportunity to load numerous APIs into a single delivery vehicle, opening the door to many new product designs.

To create this multilayer bead, the core is loaded into a CPI Wurster fluid bed coating unit and is sprayed with the first layer of coating until the desired film thickness is deposited. This layer is then dried with hot air as the bead moves upward inside the fluidization chamber before another layer is sprayed onto this newly coated bead. This process can then be continued with as many layers as necessary, with each layer containing a unique solution or the same solution. Our many years of coating experience make us capable of handling virtually any bead coating technique required.

Modified-Release Technology

Modified release technology is the ability to alter the way an active drug is released and absorbed into the body through the formulation of the drug coating. Controlled release of active ingredients from particulate material is achieved through the use of a matrix or core-shell system which provides obstacles through which the drug must migrate for release. This strategy relies on the porosity, solubility or erosion characteristics of the matrix formulation to ensure that the active ingredient is slowly released through the outer coating at a specified rate. Coating Place can formulate and manufacture controlled release particles ranging from near and below 30μm to 1cm and above. Release rates can be modified to meet any requirement: complete release delayed to an appropriate time such as to release into a specific location in the body, extended release for a required length of time to decrease the frequency of intake, or extended release for a required time after a specific delay period. The release can be governed through a variety of means such as changes in pH, temperature or solvent, as well as matrix dissolution rate or porosity. Enteric release is also common to ensure a delayed drug releases in the small intestines to avoid stomach upset, which could then be paired with immediate release or extended release to provide further control of the release profiles of the product. Coating Place can apply multiple active ingredients and numerous controlled release components to achieve the release rate you desire.

Abuse Deterrence

Controlled substance abuse is a significant problem due to the euphoric and addictive properties of these materials. Yet, these opioids are an important component in the ability to manage pain. The licensing and accountability requirements for manufacturers help reduce the dispersion of these substances, but they do not eliminate the problem. To provide a product that deters abuse involves altering the way the product coating is formulated. Some ways this is done is by creating a coated barrier that resists common solvents such as water or alcohol. Another method is providing an antagonist in the coating that is inactive during proper usage, but releases during tampering and will interfere with the euphoric sensation of the narcotic.

Coating Place is licensed to work with Schedule II-V controlled substances. We have expertise in controlled release technologies as well as controlled substance processing that can be utilized to develop and manufacture formulations with abuse deterrent properties.

Ion Exchange Technology

Coating Place has more than 30 years of experience developing and manufacturing controlled release pharmaceutical products using ion exchange technology including both liquid and solid dosage forms. Ion exchange involves loading a drug onto the resin through an exchanging reaction to produce a drug-resin complex (DRC), which is then released into the body through an exchange with the gastrointestinal fluid Ion exchange is a highly versatile drug delivery vehicle with the ability to create immediate, sustained and delayed releases. Pharmaceutical ion exchange resins can be used in formulations to provide taste-masking, controlled release, tablet disintegration, and improved stability of active pharmaceutical ingredients. Coating Place can provide customized formulations to achieve a wide range of release profiles or other desired improvements to pharmaceutical product stability, taste, or performance.

Binding a drug to an ion exchange resin to produce a DRC typically neutralizes the bitter taste associated with the drug creating a strong solution in task masking abilities. When used in tablets, ion exchange resin imparts improved disintegration due to the resin’s affinity for water. The release of a drug from a DRC is highly customizable through modifications to the DRC formula as well as the use of a semipermeable coating on the DRC. These aspects of the DRC product can be varied to achieve the desired release profiles including delayed or sustained release as well as mitigation of the risk of toxicity due to dose dumping in the system.

Our extensive history in ion exchange technology gives our scientists the ability to determine the correct ion resin formulation for each project. See Our Patent list to check out our achievements in ion exchange technology.

Taste Masked Technology

Taste is often a crucial factor in palatability of an oral dosage. Pharmaceutical, nutraceutical, nutritional, and other active materials typically have an objectionable taste which creates challenges for some forms of oral delivery. If it is confined to a tablet or capsule that is swallowed whole, the material can bypass the taste buds without significant detection. When the material is formulated as a chewable tablet, a fast-dissolve lozenge or film, product solution or suspension, objectionable taste is often the primary cause of patient non-compliance with a dosing requirement.

Taste masking is the ability to reduce the undesirable taste of the API during delivery. There are numerous ways to mask this unpalatable taste. Coating Place focuses on two processes which include Wurster coating and the creation of an ion exchange resin complex. Taste mask coatings typically use a common strategy involving the addition of a taste mask coating to the active material to delay release of the product until it has bypassed the mouth. This provides a physical barrier for the drug against the taste buds allowing the drug to enter the stomach or intestines before release.

The other technique used in pharmaceutical products at Coating Place is ionically binding an ionizable active to an ion exchange resin, which often neutralizes the bad taste. This ion-resin complex is typically formulated with a flavor system to mask residual or early releasing drug. Due to its insolubility to salivary conditions in this state, there is virtually no bitter taste detected. This process allows the complex to break down under gastrointestinal conditions and is absorbed through the stomach and intestines.

Coating Place has extensive experience in formulating and manufacturing taste masked products using Wurster fluid bed coating, ion exchange, and related technologies. Actives with extremely objectionable taste have been successfully taste-masked at final particle sizes as small as 40µm. Resin technology is commonly used in liquid suspensions, but can be applied to other solid dosage forms. Let Coating Place help create the right taste masking formula to make your product palatable to your customers.
Coating Place, Inc.

Our Technology

our-technologyCoating Place has been in the Wurster coating industry since its founding in 1976 with the original Wurster patent and prototype equipment from Dr. Dale Wurster. Our extensive experience allows us to guarantee efficient and effective manufacturing processes, creating optimal and high quality services for our customers.

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Oradel™ Platform

Our proprietary oral delivery technology is brought to you through our Oradel™ Platform. Our customers are offered extensive experience in the areas of modified release technology, multilayer coating and ion resin technology.

  • Oradel™-MC
  • Oradel™-XR
  • Oradel™-DR
  • Oradel™-EC
  • Oradel™-ION
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Coating Place, Inc. 200 Paoli Street PO Box 930310 Verona, WI 53593 Phone: (608) 845-9521 Fax: (608) 845-9526