Powder and Granule Development Services

As a biopharmaceutical company focused on the development of pharmaceutical formulations, BOC Sciences is dedicated to providing high quality powder and granule development services that help our clients bring innovative pharmaceutical products to the market swiftly and efficiently. With a focus on quality, state-of-the-art technology, and a highly skilled team, we promise solutions that are not just effective but also commercially viable.

Powders and granules

A powder is a dry bulk solid composed of many very fine particles, usually between 0.1 and 10 microns in size. They can be composed of active pharmaceutical ingredients (APIs) alone or a mixture of apis and excipients. When shaken or tilted, these particles can flow freely. Powder is a special class of granular materials, because of its small particle size often has a strong tendency to caking. In pharmaceutical applications, the powder form facilitates precision modulation of the correct dosage. Due to their flow characteristics and high surface area, powders are widely used in pharmaceutical manufacturing and delivery, such as preparation of powder, dry powder inhalants, etc. In addition, powders have a range of mechanical properties, such as changing the loose or dense state through vibration or compression, thus adjusting their fluidity and density.

Granules are larger particles that are condensed into smaller powder particles and are usually between 0.5 and 5 millimeters in diameter. Unlike powders, granules, due to their large particle size, are less prone to clumping when flowing, unless exposed to a humid environment. Granules are also important in the pharmaceutical industry and are often used in the preparation of tablets and capsules, which can be improved by specific treatment methods to make them easy to process and take. The preparation process of granules includes wet or dry granulation, which is a key technology to ensure uniform granule and good fluidity.

Advantages of powder and granule formulations

Dosing flexibility: Powders allow for precise dosing, accommodating varying patient needs, especially in pediatric and geriatric populations who may struggle with conventional dosage forms like tablets and capsules.

Rapid onset of action: Powders generally dissolve faster than tablets or capsules, leading to quicker absorption and therapeutic effects, an essential factor in acute treatments.

Stability: Many drugs exhibit greater stability in solid forms compared to liquid formulations, reducing the risk of degradation and extending shelf life.

Our powder and granule development services

Pre-formulation research: Comprehensive analysis including solubility testing, particle size distribution and compatibility studies.

Formulation development: Work closely with customers to develop tailor-made formulations to meet specific therapeutic needs. Our formulation scientists employ a variety of techniques to optimize particle size, shape and distribution, ensuring maximum bioavailability and stability.

Formulation optimization: Apply robust Design of Experiments (DoE) methods to optimize the efficacy, stability, and manufacturability of formulations.

Reduction and control of particle size: Advanced grinding technologies, including grinding, grinding and suspension, are used to achieve a uniform particle size distribution. This process is essential to ensure consistent performance and accurate dosing. Our crushing technologies are:

• Individual crushing: refers to the operation method of crushing only one medicine at a time. Valuable drugs and stimulant drugs should be crushed separately in order to reduce losses and facilitate labor protection.
• Mixed crushing: refers to the operation of crushing two or more kinds of medicinal materials at the same time. Mixed grinding can avoid the aggregation of sticky walls and powder particles of some sticky or thermoplastic medicinal materials, and can make the grinding and mixing operation at the same time.
• Cold extraction crushing method: The brittleness of medicinal materials increases at low temperature, and the drug is frozen before or during the crushing process by using the characteristics of the drug's brittleness at low temperature. Suitable for crushing of fibrous medicinal materials.
• Wet crushing: It is a crushing method of adding an appropriate amount of water or other liquids to medicinal materials, also known as liquid grinding method. The drug and water are ground in a mortar or ball mill, so that the fine powder floats on the water surface or hangs in the water, and then the suspension is poured out, and the remaining coarse material is added with water and repeated operation until all the drug is ground. Some mineral drugs that are insoluble in water, such as cinnabar, pearl, talc, etc. require special fineness, and are often crushed by water flying method.
• Dry crushing: refers to the proper drying treatment of medicinal materials, so that the water content of medicinal materials is reduced to a certain limit and then crushed.

Granulation technology: Both wet and dry methods allow us to create particles that enhance fluidity and compressibility. The granulation process is optimized to improve the stability and solubility of the final product.

• In wet granulation, a solvent (usually water or ethanol) is used to bond powder materials together to form uniform particles. In high-shear granulation, the solid and liquid components are rapidly mixed by a high-speed rotating cutter head to form a uniform slurry, which is then further cut and kneaded into a ball. In fluidized bed granulation, the powder is suspended in the air stream and the adhesive is sprayed to form particles. This method can control the size distribution and appearance quality of particles more effectively.
• Dry granulation does not use any liquid adhesives, and the main techniques include roller granulation and tablet granulation. The press roller granulation is formed by pressing the material between the press rollers, and then the final particle is formed by crushing and whole grain, and the press granulation machine is directly pressing the powder into tablets through strong pressure, and then broken into particles. This technology has the advantages of simple processing and energy saving, and is especially suitable for some drugs that are not suitable for heat treatment.

Quality assurance: Adhere to strict quality control measures throughout the development process. Our laboratories are equipped with state-of-the-art analytical instruments to evaluate key parameters such as particle size, moisture content and dissolution rate. Regular testing ensures that each formulation meets customer specifications and complies with industry regulations.

Stability testing: Conduct a comprehensive stability study to assess how environmental factors such as temperature, humidity, and light affect the integrity of the product over time. These studies help predict shelf life, enabling customers to make informed decisions about packaging and storage conditions.

Advanced technology and equipment capability

High-speed mixing granulator: The powder is evenly mixed by rotating the blade and high-speed shearing, and the wet particles are formed after adding the adhesive. Its main advantages are uniform mixing, high granulation efficiency, and can ensure the uniformity and stability of particles.

Spray dryer: Spray drying is a technique widely used in powder drug preparation, by spraying liquid drug solutions or suspensions into small droplets and then drying quickly in hot air to obtain a fine powder. This method has the advantages of high efficiency, stability and strong controllability.

Roller press: The powder raw materials are extruded into sheets or strips by two relatively rotating rollers, and then broken to form particles. The technology has the characteristics of low energy consumption, no heating, suitable for heat-sensitive drugs, and can effectively improve the solubility and bioavailability of drugs.

Vibrating screen machine: The use of vibration motor as a vibration source, so that the material on the screen for three-dimensional movement, so as to achieve the purpose of screening.

Freeze-dryer: Freeze-drying is a drying method that removes moisture at low temperatures, especially for heat-sensitive drugs. This technology can maintain the structure and activity of the drug well, and is an important means to prepare high-quality powder drugs.

Airflow crusher: Airflow pulverization is a technology that uses high-speed airflow or ultrasound to crush drug particles to the micron or even nanometer level, often used to improve the solubility and bioavailability of drugs. The jet mill plays an important role in the preparation of fine powder.

Fluidized bed granulator: Fluidized bed technology works by suspending drug particles in an air stream and then spraying an adhesive solution to aggregate them into particles. This device is used to produce uniform drug particles, improving powder fluidity and tablet performance.

Co-spray dryer: This technique spray dries two or more substances at the same time to prepare a composite powder. The method is used to manufacture pharmaceutical preparations with improved solubility and stability.

Microwave drying equipment: Microwave drying uses microwave energy to directly heat the water in the drug mixture, which has the characteristics of fast and uniform, suitable for the treatment of heat-sensitive drugs and high value-added drugs.

Efficient mixer: Mixing equipment such as ribbon mixers and V-shaped mixers are used to evenly mix multiple powder ingredients, ensuring consistency and uniformity of each batch of medication.

Other analysis equipment include:

Why choose BOC Sciences?

• Customized formulations: We tailor formulations to meet specific treatment needs, ensuring optimal efficacy and patient compliance for each product.
• Fast development cycles: Our streamlined processes shorten turnaround times, which speeds up your time to market.
• Advanced technology: Using advanced equipment and technology, we ensure high precision in particle size control and formulation consistency.
• Expertise and experience: Our team of experts has extensive experience in drug development and can provide valuable insights and guidance throughout the process.
• Strict quality control: We implement strict quality assurance protocols at every stage to guarantee compliance with regulatory standards and ensure product reliability.
• Cost-effectiveness: By optimizing formulations and processes, we help reduce overall production costs while maintaining high quality standards.

FAQ

1. Why choose powders or granules for drug formulation?

Powders and granules offer unique advantages, including flexibility in dosing, rapid onset of action, enhanced stability, and versatility for various delivery routes (oral, topical, inhalation). They also allow for customization based on specific therapeutic needs.

2. What types of formulations can you develop?

We specialize in a wide range of formulations, including those for immediate-release, sustained-release, effervescent powders, granules for reconstitution, and topical dusting powders. Our formulations are tailored to meet the specific requirements of each client.

3. What kind of stability testing do you conduct?

We conduct extensive stability testing to assess the effects of temperature, humidity, light, and other factors on product integrity. This includes long-term, accelerated, and real-time stability studies to predict shelf life and ensure compliance with regulatory standards.

4. What is the particle size and distribution of powder?

Particle size and distribution are important parameters to describe the particle size of powder and its distribution in different size ranges. Particle size can be measured by sieving method, microscope method, laser scattering method, etc. Understanding and controlling the particle size has an important effect on the application and properties of powders.