Oral Liquid Dosage Form Development

At the forefront of the pharmaceutical industry, oral liquid dosage forms have become an indispensable part of the drug delivery system with their unique charm and wide adaptability. Especially in pediatrics, geriatric medicine, and the treatment of patients with swallowing disorders, oral liquid dosage forms show unparalleled advantages. BOC Sciences, the industry leader in oral liquid formulations, offers comprehensive, customized R&D services covering the full spectrum of products from oral solutions, suspensions, oral emulsions to drops, syrups and even tinctures to meet the diverse needs of different drug properties and patient populations.

Advantages of oral liquid dosage forms

Improved bioavailability: Compared to traditional solid dosage forms, oral liquid dosage forms show a revolutionary breakthrough in improving drug bioavailability. For drugs with limited solubility or that experience significant first-pass effects, we can significantly improve the dissolution rate and absorption efficiency of the drug by carefully modulating the pH environment and introducing strategies such as high-potency solubants, thereby enhancing the therapeutic effect.

Dose accuracy: Another highlight of oral liquid dosage forms is the precise control of the dose. Whether it is a young child or an elderly person with impaired swallowing function, simple tools such as a dropper or measuring cup can easily achieve personalized dose adjustment, ensuring accurate and safe drug treatment.

Improved taste: Through the clever addition of taste enhancers and sweeteners, the taste of the drug can be significantly improved, making it milder and easier to accept, and effectively improving patient compliance with the treatment plan, especially for children and adults who are sensitive to the taste of the drug.

Easy to carry and use: The application of modern packaging technology makes oral liquid medicines both convenient to carry and easy to use, especially some out-of-the-box small package designs.

Type of oral liquid dosage forms development

Oral solution

Advanced solubility enhancement technology and prescription optimization strategy were used to design highly efficient oral solution formulations for insoluble drugs. The application of ultrasonic assisted dissolution, particle size control and other technologies has greatly improved the dissolution rate and absorption efficiency of drugs. At the same time, stability studies ensure that products maintain excellent chemical and physical stability under complex storage conditions.

Suspension and oral emulsion

In the face of water-insoluble drugs, advanced suspension and emulsification processes are used to prepare uniform and stable suspension and oral emulsion. By means of particle size distribution analysis and Zeta potential measurement, the particle properties are fine-adjusted to ensure the long-term stability of the preparation. The biocompatibility test and the careful selection of emulsifier and suspension aid further optimize the digestive tract compatibility of the preparation and improve the comfort of patients.

Drops and syrups

We have specially developed drops and syrups to meet the special needs of children and patients with dysphagia. Through precise formula design, incorporating natural taste correctors and sweeteners, not only the concentration of the drug is maintained, but also the taste is significantly improved, making the drug more friendly and delicious. The dual guarantee of dose accuracy and taste testing ensures that every drop of medicine is accurately delivered to maximize its therapeutic potential.

Tinctures

As representatives of traditional dosage forms, tinctures still have a place in modern pharmaceutical preparations. Through the innovation and improvement of the classic preparation process, combined with modern analytical techniques such as high performance liquid chromatography (HPLC) and gas chromatography-mass spectrometry (GC-MS), the extraction efficiency and purity of the active ingredients are strictly monitored to give the tincture a new vitality, ensure its safety and effectiveness, and inject the soul of modern science and technology into the traditional dosage form.

Oral liquid dosage forms development process

Formulation design and optimization

According to the physicochemical properties, stability and clinical needs of the drug, carefully designed the composition of the prescription. Through the clever combination of single factor experiment and orthogonal experiment, the best solvent, solubilizer, stabilizer and taste modifier were selected, and the prescription ratio was optimized to ensure the excellent performance of the preparation in solubility, stability, taste and bioavailability.

Production process development

The development of production technology directly affects the yield and quality stability of the preparation. Develop detailed production processes, including raw material handling, dissolution, mixing, homogenization, filling, sterilization, in combination with drug characteristics and prescription design. Through the stages of small trial, pilot trial and scale-up production, the production process parameters are continuously optimized to ensure the smooth large-scale production of the preparation.

Oral liquid dosage forms stability study

By simulating different temperature, humidity and light conditions, the appearance, content, impurities and other indicators of the preparation are regularly monitored to evaluate the stability of the preparation scientifically. The accurate prediction model is established to provide solid data support for the prediction of the expiration date of the preparation, and lay a solid foundation for product registration and listing.

Safety and efficacy evaluation

The evaluation of drug safety and efficacy is a top priority in the development process. In strict accordance with the requirements of national drug registration laws and regulations, the safety and effectiveness of the preparations are systematically evaluated. The toxicity and pharmacokinetic properties were evaluated by animal experiments.

Our service advantages

Customized research and development solutions

From the beginning of the project, our professional team will work closely with customers to deeply understand the characteristics of drugs, treatment goals and patient needs, formulate scientific and reasonable research and development strategies, and provide customers with one-on-one customized research and development solutions.

Advanced experimental facilities and technology

BOC Sciences has international advanced experimental facilities and technical platforms to provide strong support for the research and development of oral liquid preparations. The laboratory is equipped with high-precision analytical instruments, automatic liquid dispensing system, particle size analyzer and other equipment, which can accurately control the parameters of the preparation to ensure stable and reliable product quality. At the same time, advanced preparation technologies, such as nanotechnology, microemulsion technology, supercritical fluid extraction technology, etc. are used to improve the solubility and bioavailability of drugs and optimize the performance of the preparations.

Strict quality control

A sound quality management system has been established. From raw material procurement, production process to finished product inspection, each link strictly follows the GMP standard, with steam sterilization cabinet, tunnel sterilization dryer, far infrared sterilization oven and other equipment to ensure the quality and safety of preparation products. Adopt advanced testing technology and equipment to carry out comprehensive and accurate testing of various indicators of the preparation to ensure that the product meets the drug quality standards.

FAQ

1. What are the key stages in the development process?

• Pre-formulation studies: Assessing the physicochemical properties of the API.
• Formulation development: Designing and optimizing the formulation.
• Analytical testing: Ensuring the quality and consistency of the formulation.
• Stability studies: Determining the shelf life and storage conditions.

2. How do you ensure the stability of oral liquid formulations?

• Accelerated stability testing: Predicting long-term stability by exposing the formulation to elevated temperatures and humidity.
• Real-time stability testing: Monitoring the formulation under normal storage conditions.
• Photostability testing: Assessing the impact of light exposure on stability.

3. What analytical tests do you perform on oral liquid formulations?

• Assay and purity testing (HPLC, GC, mass spectrometry)
• pH and viscosity measurement
• Microbial testing
• Particle size analysis (for suspensions and emulsions)

4. How do you ensure the formulations are palatable?

We incorporate flavors, sweeteners, and taste-masking agents to improve the palatability of our formulations, making them more acceptable to patients, especially children.

5. What regulatory guidelines do you follow?

We adhere to relevant regulatory guidelines, including those from ICH, FDA, and EMA, to ensure our formulations meet stringent quality and safety standards.

6. Can you customize formulations to meet specific client requirements?

Yes, we offer customized formulation development services to meet the specific needs of our clients. Our team works closely with clients to understand their requirements and develop formulations that align with their therapeutic goals.

7. How do you handle APIs with low solubility?

For APIs with low solubility, we develop oral suspensions where the drug particles are uniformly dispersed in the liquid medium. We also explore solubilization techniques and the use of appropriate solvents to enhance solubility.

8. What technologies do you use for particle size analysis?

We utilize advanced technologies such as laser diffraction for particle size analysis, ensuring uniformity and consistency in suspensions and emulsions.

9. What measures do you take to ensure microbial integrity?

We perform rigorous microbial limit tests and sterility testing to ensure the microbial integrity of our formulations, preventing contamination and ensuring patient safety.

10. How do you determine the appropriate excipients for a formulation?

We conduct excipient compatibility studies during the preformulation phase to identify excipients that are compatible with the API and enhance the stability, efficacy, and palatability of the formulation.

11. How do you ensure the quality of your formulations?

Our quality assurance measures include stringent analytical testing, stability studies, and adherence to regulatory guidelines. We employ a robust quality management system to ensure the highest standards are maintained throughout the development process.