Semi-solid Dosage Form Development
In the biopharmaceutical sector, BOC Sciences focuses on formulation development and is committed to providing superior biopharmaceutical services to customers worldwide. Our service portfolio covers a full range of semi-solid dosage forms, leveraging advanced technology and deep industry insights to provide tailored solutions to precisely meet your drug development needs.
What is semi-solid dosage form?
Semi-solid preparation is a common form of pharmaceutical preparation in pharmacy, whose physical state is between solid and liquid. Semi-solid preparations are characterized by a certain consistency and plasticity, can be better attached to the skin or mucosal surface, provide continuous drug release, suitable for local treatment. They can be used for skin diseases, eye, ear, nasal, rectal and other delivery routes.
The preparation of semi-solid dosage forms usually requires the use of matrix materials, such as oils, water-soluble polymers, silicone oils, etc., which not only give the preparation specific physical properties, but may also affect the release rate and bioavailability of the drug. In addition, in order to improve drug stability, improve patient compliance or increase drug absorption, preservatives, thickeners, emulsifiers, antioxidants and other excipients may also be added to semi-solid dosage forms.
Types of semi solid dosage form
Ointment: Made by mixing drugs with suitable substrates (such as oily, emulsion or water-soluble substrates), it has the effect of lubricating and protecting the skin, and is widely used in the treatment of skin diseases. According to the type of matrix, the type of ointment and the amount of preparation, there are three preparation methods: melting method, grinding method and emulsification method.
Cream: As an emulsion-type semi-solid preparation, the cream is divided into oil-in-water and oil-in-water types, and its good permeability and moisturizing properties make it ideal for a variety of skin conditions.
Gel: The gel agent is divided into single-phase gel and two-phase gel according to the dispersion system.
- Monogels are gels formed by dispersing molecules in the gel matrix, which are divided into water-based gels and oil-based gels. The water-based gel matrix consists of cellulose derivatives, carbomer and alginate, tragacanth, gelatin, starch, etc., plus water, glycerol or propylene glycol. The oily gel matrix is composed of polyoxyethylene, colloidal silicon, aluminum soap, zinc soap, fat oil and liquid paraffin.
- Two-phase gel drug colloidal particles are uniformly dispersed in the polymer network structure of the liquid, with thixotropy, such as aluminum hydroxide gel.
Paste: By mixing drugs with powder or granular matrix, mainly used in the treatment of skin diseases, such as eczema, dermatitis, etc.
Eye ointment: A semi-solid preparation specially designed for the eye, which must meet strict sterile standards and has a mild, non-irritating matrix, mainly used for the treatment of eye infections and inflammation.
Suppository: After inserting into the cavity, it should be quickly softened, melted or dissolved in the secretion under the action of body temperature, and gradually release the drug to produce local or systemic effects, effectively avoid the liver first-pass effect, and significantly improve the bioavailability of the drug.
Semi solid dosage form advantages
Strengthen patient compliance: The semi-solid dosage form, with its convenient use and comfortable sensory experience, significantly improves patients' acceptance of treatment options. Whether it is immediate relief or continuous release, the formulation is designed to effectively respond to the needs of the patient, ensuring continuity of the treatment process and overall patient compliance, thus injecting more possibilities into disease management.
Both local and systemic effects: The flexibility of these formulations makes them ideal for local therapy and systemic drug delivery. On the one hand, local application can accurately locate the lesion and provide targeted therapy; On the other hand, innovative forms such as transdermal gels and patches can cross the skin barrier to achieve effective drug absorption and distribution throughout the body, broadening the application range and therapeutic potential of semi-solid dosage forms.
Multifunctional formulation: The versatility of semi-solid formulations in formulation design makes them a powerful weapon in response to complex medical needs. No matter in the face of hydrophilic or lipophilic drugs, the optimal bioavailability and therapeutic effect can be achieved through precise formulation. This high degree of customization not only covers a wide range of drug types, but also ADAPTS to diverse medical scenarios to provide patients with personalized treatment plans.
Controlled drug release: Thanks to advanced formulation technology, semi-solid dosage forms achieve controlled release characteristics, ensuring stable release of the drug at a predetermined time, effectively extending the action time and reducing the frequency of administration. This innovation not only greatly facilitates patients, but also improves the accuracy and efficiency of treatment, opening up a new path for the long-term management of chronic diseases.
Enhance drug stability: Carefully formulated semi-solid dosage forms can significantly improve the stability of drugs and excipients, especially for those drugs that are sensitive to environmental factors such as light, temperature, humidity, and so on, providing an additional layer of protection. This enhanced stability not only extends the shelf life of the drug, but also ensures the quality and safety of the drug during storage and transportation, laying a solid foundation for patients to obtain consistent treatment effects.
Comprehensive semi-solid dosage form development service
Formulation development
Our formulation development services focus on building semi-solid dosage forms that meet both regulatory requirements and therapeutic goals. This process involves several key steps:
Pre-formulation studies: Complete analysis of the underlying properties of the active pharmaceutical ingredient (API), including but not limited to properties, structure, molecular weight, stability, crystal form, solubility, particle size distribution (for specific dosage forms), compound impurities and their formation mechanisms. Through in-depth characterization of API and excipients, we have mastered their physical and chemical properties, laying a solid foundation for subsequent development.
Formulation design: Using scientific design concepts, we develop prototype formulations designed to achieve preset therapeutic effects. At this stage, the formulation is accurate and safe by taking into account the total dose of the drug, the surface area of administration, the concentration (dose per unit area), the timing of administration, the site of administration, the viscosity of the preparation, and the potential sensitization.
Compatibility studies: Evaluate the interaction between API and excipients to ensure stability and efficacy of the formulation. This process covers the selection and integration of excipients such as osmotic enhancers, emulsifiers, bacteriostatic agents, solvants, antioxidants, etc., in order to build a stable and effective drug system.
Optimization and scale: Through detailed testing and optimization processes, constantly improve the formula and eventually scale it up to commercial production scale, achieving seamless docking from the laboratory to the market.
Analysis method development
Method development and validation: Establish and validate a robust set of analytical methods for qualitative and quantitative testing of apis and excipients. Covers appearance, viscosity, pH, related substances, microstructure, volatile loss, stability testing, influence factor analysis, particle size and distribution of dispersed phase, crystal type, droplet size, uniformity and detection of specific excipients (e.g. antioxidant) content to ensure accuracy and reliability of data.
Stability testing: In a diverse range of environmental conditions, we perform comprehensive stability studies aimed at assessing the quality life of products to ensure compliance with regulatory requirements. The test includes chemical and physical degradation paths (sololysis, oxidation, photolysis, dehydration, polycrystalline transformation, vaporization, aging, adsorption, etc.), as well as the effects of temperature, humidity, pH, crystal form, additives, light, radiation and other factors on the stability of the preparation.
Microbial testing: Microbial content testing and anti-corrosion effectiveness assessment to ensure product safety and prevent microbial contamination.
In vitro evaluation of transdermal preparations: In vitro release test (IVRT) is an effective means to characterize and evaluate the performance of semisolid preparations. In vitro release rate can reflect the combined effect of various physicochemical parameters such as solubility, particle size, rheology of dosage form, etc. The IVRT devices for semi-solid preparations mainly include vertical diffusion cell, immersion cell and flow cell. The data measured by the same sample using the above three devices may be different. The vertical diffusion cell is simple and has good reproducibility. Advanced equipment such as Franz diffusion cell was used to evaluate the in vitro release, transdermal permeability, crystal shape effect and irritation of drugs, providing a scientific basis for the optimization of transdermal preparations.
Fig. 1 Vertical diffusion cell model A.
Rheological characterization
Viscosity measurement: With the help of a precision rheometer, the viscosity curve is determined to ensure the ideal texture and spreadability of the preparation.
Flow behavior analysis: Evaluate thixotropy and shear thinning characteristics to optimize the flow of formulations and enhance the patient experience.
Texture analysis: To investigate the robustness, cohesion and adhesion of the preparation to enhance its mechanical properties and improve patient compliance.
Customized semi-solid dosage form development service
According to the special needs of different patient groups, such as the fun design of children's medication, the convenience of the elderly, etc., to provide tailored personalized services. By innovating the appearance of the dosage form, optimizing the feeling of use, and integrating special ingredients, the drug is closer to the life style of the patient, thus significantly improving the treatment compliance.
Advanced equipment at BOC Sciences
- High shear mixer
- Planetary mixer
- homogenizer
- Rotating and oscillating rheometer
- Differential scanning calorimeter (DSC)
- Thermogravimetric analyzer (TGA)
- Vertical diffusion cell
From formulation design to process development to performance evaluation and stability studies, BOC Sciences provides a one-stop service to reduce the cost of communication and coordination between different stages of the customer and accelerate the process to market.
FAQ
1. What are the advantages of semi-solid dosage forms?
Semi-solid dosage forms offer several advantages, such as enhanced patient compliance due to ease of application and comfort, the ability to provide localized or systemic effects, versatility in formulation for various therapeutic needs, controlled release properties, and improved stability for sensitive drugs.
2. What services do you offer in semi-solid dosage form development?
Formulation development: Pre-formulation studies, formulation design, compatibility studies, and optimization and scale-up.
Analytical method development: Method development and validation, stability testing, and microbiological testing.
Rheological characterization: Viscosity measurement, flow behavior analysis, and texture analysis.
Regulatory support: Regulatory strategy development, documentation and submission, and compliance audits.
3. How do you ensure the quality and consistency of your formulations?
We ensure quality and consistency through robust formulation development processes, rigorous analytical method development and validation, comprehensive stability testing, and adherence to good manufacturing practices (GMP). Our advanced equipment and experienced team also play a crucial role in maintaining high standards.
4. Can you customize formulations based on specific client needs?
Yes, we offer highly customizable services to meet the unique requirements of each client. We tailor our formulation development processes to achieve specific therapeutic goals and comply with regulatory standards.
5. Do you offer end-to-end support for drug development?
Yes, we provide end-to-end support throughout the drug development process, from initial formulation design to final regulatory submission. Our integrated approach ensures a seamless transition from the laboratory to the market.
6. How can I get started with your semi-solid dosage form development services?
To get started, you can contact us for an initial consultation where we will discuss your project requirements, therapeutic goals, and regulatory considerations. From there, we will develop a tailored plan to meet your specific needs and guide you through the development process.