Capsule Development Services

BOC Sciences is a biopharmaceutical company focused on the development of pharmaceutical formulations. With years of experience and a dedicated technical team, our capsule development services cover all stages from concept design to product development. We are committed to providing our customers with the highest quality drug discovery services through innovation and technology.

What is capsule?

Capsules are solid preparations made by filling the drug or suitable excipients in hollow hard capsules or sealed in soft capsules. The first capsule appeared in 1834, by the French pharmacist F. Mothes prepared from gelatin. Capsules are mainly composed of two parts: capsule shell and contents. Capsule shells are usually made of gelatin or other polymer materials and have good biocompatibility and degradability. Gelatin capsules dissolve in body fluids in the gastrointestinal tract, releasing the drug. For some patients or vegetarians who are intolerant to gelatin, they can choose a plant capsule shell, such as hydroxypropyl methylcellulose (HPMC) capsules.

The contents are the active ingredients in the capsule and can be powders, particles, microcapsules or even liquids. Different drug properties determine the diversity and complexity of the contents of the capsule. For example, some unstable drugs can be wrapped in microsacs, preventing them from breaking down or failing during storage and transportation.

According to the material of the capsule shell and the state of the contents, capsules can be divided into hard capsules and soft capsules. Hard capsules are usually used to carry powders or particles, while soft capsules are mostly used to carry liquid or oily substances. The capsule shell of a hard capsule is usually composed of two parts, which form a closed structure by clamping, while a soft capsule is sealed by a heat sealing technique.

Advantages of capsules

The capsules can cover up the bad smell of drugs, avoid the stimulation of drugs to the mouth and esophagus, stabilize the physicochemical properties of drugs, and control the speed of drug release. Since many drugs taste bitter and are not easily accepted by patients, the encapsulation of the capsule shell effectively masks this bad taste. Capsules can accurately quantify the drug, ensuring the same dose is taken each time, reducing medication errors. The capsule has strong adaptability to environmental factors, and it can be divided into many drugs that are easy to absorb moisture and oxidize, effectively protecting the stability of drugs.

Our comprehensive capsule development services

Formulation design and optimization

Drug screening and solubility studies: including purity, granularity, solubility of active ingredients. Through strict drug screening and solubility study, to ensure that the selected drugs have good solubility, improve the bioavailability of drugs.

Capsule filling optimization: Select the most appropriate combination of excipients according to the characteristics of the drug, optimize the capsule filling, so that the drug has the best release characteristics in the body.

Process development: Detailed design and optimization of the capsule production process, including mixing, granulation, filling and sealing, to ensure repeatability and efficiency of production.

Human gastrointestinal simulation experiment: Through the advanced simulation experiment system, the release behavior of drugs in the human body can be predicted to improve the scientific formula design.

Process development and validation

After the formulation is determined, BOC Sciences conducts detailed process development and validation, including:

• Mixing and granulation process
• Filling process
• Encapsulation processes
• Cooling and packaging process

Our process development follows strict GMP standards to ensure product consistency and repeatability.

Capsule filling service

Hard capsule filling: Usually suitable for dry materials such as powders, particles and pellets. The capsules consist of two parts, the main raw material is gelatin or vegetable cellulose, and the material is filled into the capsule shell by precision equipment during the filling process. Our hard capsule filling machines include semi-automatic and fully automatic models to meet the needs of different production scales.

Soft capsule filling: Mainly used for liquid, oil and some viscous materials. The shell of this kind of capsule is usually made of gelatin, glycerin and water and other materials, which has certain elasticity and sealing property. Soft capsules are suitable for the inclusion of fat-soluble substances or volatile ingredients, such as fish oil, vitamin E, etc., which can improve the stability and bioavailability of the product. Softgel filling technology includes a variety of processes such as centrifugal filling, reciprocating filling and rotary forming, which can be optimized for different materials and product needs.

Quality control and stability research

Analytical services: Our quality control laboratory is equipped with advanced analytical instruments to perform comprehensive product testing such as content uniformity, release, microbial limits and more.

Accelerated and long-term stability testing: Through accelerated and long-term stability studies, we assess the stability of drugs throughout their shelf life, ensuring that products do not change in quality during storage and transportation.

Package compatibility study: Evaluate the compatibility between drugs and different packaging materials to avoid drug degradation or adsorption due to compatibility problems.

Preclinical study

Preclinical pharmacokinetic studies: BOC Sciences conducts pharmacokinetic studies including absorption, distribution, metabolism, and excretion (ADME) to provide comprehensive data to support the safety assessment of the drug.

Toxicological studies: Acute, subchronic and chronic toxicological evaluation using in vivo and in vitro models to ensure drug safety.

Small-scale to large-scale capsule production

BOC Sciences offers comprehensive services from small-scale to intermediate and large-scale production. At each stage, we conduct rigorous quality control to ensure that the products meet customer requirements and regulatory standards.

Advanced technology and equipment capability

BOC Sciences has advanced equipment and technology in granulation, mixing, filling, coating, testing, packaging and control system, which can greatly improve the production efficiency and quality of capsules, and provide strong support for the development of the pharmaceutical industry.

Why choose BOC Sciences?

• Time and cost efficiency
• Customized capsule development solution
• International advanced research and development and production equipment
• Research and development teams covering pharmaceutical chemistry, pharmaceutical engineering, biotechnology and other fields
• Strict quality control

FAQ

1. What is capsule development?

Capsule development involves formulating and producing capsules that safely deliver active pharmaceutical ingredients (APIs) to patients. This process includes formulation design, filling, stability testing, and compliance with regulatory standards.

2. What are the benefits of using capsules over other dosage forms?

Capsules offer several advantages, including ease of swallowing, improved bioavailability, and the ability to mask unpleasant tastes or odors. They also provide flexibility in formulation options.

3. What analytical testing services do you provide?

We conduct a range of analytical tests, including dissolution testing, content uniformity, and microbiological testing, to ensure the quality and efficacy of our capsule formulations.

4. How to ensure the stability of capsules?

We ensure the stability of capsules throughout the effective period through systematic stability studies, including accelerated tests and long-term tests.

5. What types of capsules can you handle?

We can handle all types of capsules, including gelatin capsules, botanical capsules and special functional capsules (such as slow-release capsules).