The search for effective and stable pharmaceutical and nutraceutical formulations presents constant challenges. One of them is the manipulation of active ingredients (IFAs) moisture -sensitive, like probiotics and vitamins. In that regard, even water can compromise the power and life of crucial components. In this scenario, surge o PEARLITOL® ProTec, An innovative co -owned manitol and starch, that acts as a strategic ally for direct compression processes. Like this, offers robust protection against the deleterious effects of moisture.
Moisture challenges for active ingredients
Moisture, or rather, water activity (Aw), represents the amount of free water in a product. This free water can support chemical reactions, enzymatic and microbial growth. For sensitive ifas, This free water can start degradation processes. These processes decrease their effectiveness over time.
Probiotics, Beneficial living microorganisms, are particularly vulnerable to humidity, What can compromise your viability. Consequently, its health benefits are reduced. Vitamins may also suffer oxidative degradation, that is accelerated by the presence of water.
Therefore, stability becomes a primordial consideration. This occurs in the development of formulations that contain these delicate ingredients. Controlling water activity is critical, which ensures that the product maintains its quality and effectiveness. This applies for all its expiration date.
Traditional methods to deal with moisture sensitivity often involve additional and complex steps. Controlled Drying of Ingredients is an example. The use of protective coatings is another. The question is the increase in costs and increasing the complexity of the manufacturing process.
PEARLITOL® ProTec: an effective barrier against moisture
O PEARLITOL® Protec emerges as an efficient solution for these challenges. He is a co -owned excipient, that results from the synergistic combination of manitol and starch. It was developed specifically for direct compression processes. This applies to moisture -sensitive ingredients.
Its main feature lies in its very low moisture content (below 1%) and water activity (below 0.2). Due to these intrinsic properties, o PEARLITOL® Protec creates a dry microenvironment that surrounds sensitive IFA. Like this, It protects you from exposure to moisture. This occurs during the crucial stage of tablet formation, including compression. Additionally, guarantees the stability of the final product over time.
Preserving the viability of probiotics with direct compression
The application of Pearlitol® Protec in probiotic formulations deserves special attention. They are remarkably sensitive not just moisture, but also at the pressure that is exerted during the compression process. High compaction forces can damage probiotic cell structure and this dramatically reduces their viability. Therefore, its therapeutic effectiveness is compromised.
In this context, o PEARLITOL® Protec demonstrates a remarkable ability to maintain the viability of probiotics even under direct compression. Its structure and low water activity create a protective matrix that minimizes the impact of pressure on microorganisms.
In addition, The low -time AW contributes to the long -term stability of probiotics. This occurs during storage. Thus, ensures that the consumer receives a product with the counting of viable microorganisms declared. This applies until the end of the shelf life.
Simplest manufacturing process, at least
The adoption of Pearlitol® Protec offers significant advantages in simplifying the manufacturing process and cost savings. Its low water activity eliminates the extra additional drying step. This step would be necessary with other diluents. The objective would be to ensure the stability of moisture -sensitive ingredients. This elimination of a complex and time consuming step results in saving time, ENERGY AND RESOURCES.
Additionally, o PEARLITOL® Protec is an overwhelming excipient ready for use. This means that it already has the desired functional properties, which reduces the need for additional processing steps. Complex quality controls are also less necessary. Its versatility makes it suitable for various forms of dosage. This includes masticable and compressed compresses with probiotics. Hard capsules, Stick packs and sachets are also examples, offering flexibility to formulators.
Additional benefits for the patient and the formulator
In addition to protection against moisture and simplification of the process, o PEARLITOL® Protec offers other important benefits. Its sweet and pleasant taste improves the palatability of formulations. This is especially relevant for masticable tablets and other oral forms. Consequently, This feature contributes to better patient conformity and makes the consumer experience more pleasant.
The ability to formulate pharmaceutical forms of discreet use, as chewable pills, also increases the convenience for the patient. Additionally, o PEARLITOL® Protec demonstrates the ability to maintain the stability of moisture sensitive. This occurs regardless of the compression force used. That way, offers greater flexibility in developing formulations with different release profiles.
Global Regulatory Compliance
O PEARLITOL® Protec meets strict quality standards, in accordance with the main global pharmacopias. This includes EP/PH.eur., USP-NF/Ph, JP/Ph e USP-NF/FCC. This regulatory compliance facilitates its acceptance and use in different markets around the world.
PEARLITOL® Protec - Intelligent choice for stable and effective formulations
In a pharmaceutical and nutraceutical scenario increasingly focused on stability and effectiveness, o PEARLITOL® Protec stands out. It is an innovative and versatile solution for formulations containing moisture -sensitive ingredients. Additionally, simplifies the manufacturing process and offers sensory benefits.
Therefore, It becomes the intelligent choice for formulators who seek to develop high quality products with excellent stability. When considering Pearlitol® ProTec, Formulation developers can overcome the challenges of moisture, delivering effective and reliable products to consumers.
Enter in contact with Barentz and learn more about this and several other solutions for your formulations.