As a leading biopharmaceutical company, BOC Sciences provides ointment development service to meet the different needs of customers. We are equipped with a professional research team and advanced equipment to provide end-to-end solutions from the initial formulation design to the final product optimization.
Ointment is a semi-solid preparation applied externally to the skin or mucous membranes. Their ingredients soften, but do not melt when applied to the skin. In treatment, ointments act as skin protectors and emollients, but they are primarily used as carriers for the topical application of drugs.
Ointments can be categorized based on their interaction with water:
Hydrophobic (lipophilic) ointments: These are mostly anhydrous formula and can only absorb trace water. The main components include water-insoluble hydrocarbons, such as paraffin, vegetable oil, animal fat, wax, synthetic glycerol and polyalkylsiloxane.
Water-emulsifying ointments: This type of ointment has a strong ability to absorb water. It is usually prepared by mixing a hydrophobic fatty substance with a water-in-oil (w/o) emulsifier such as lanolin, lanol, sorbitan ester, monoglycerol, or fatty alcohol. This gives the ointment a hydrophilic appearance and the ability to accommodate additional aqueous solutions.
Hydrophilic ointments: This type of ointment base is easily miscible with water. It is generally composed of liquid and solid polyethylene glycol (PEG) to form a mixed system.
Physical and chemical properties: Molecular weight, solubility, and crystal form.
Stability profiling: We examine stability in various environmental conditions to ensure the API can withstand the intended storage and use conditions.
Solubility and dissolution: Critical for determining how the drug will release from the ointment base and be absorbed by the body.
Compatibility studies: Interaction between the API and excipients is evaluated to avoid adverse reactions that could affect the ointment's stability or efficacy.
Using scientific principles and industry best practices, our team designs formulations that align with therapeutic goals and regulatory requirements. We take into account various factors to create the most effective and safe ointment formulations:
API concentration: Optimizing the dose per unit area for effective therapeutic outcomes.
Application site: We tailor formulations for specific body areas (skin, mucous membranes) considering absorption rates.
Viscosity and texture: Ensuring that the ointment has the desired spreadability and ease of application.
Sensitivity considerations: For sensitive or damaged skin, we select excipients that minimize irritation while maximizing efficacy.
Our formulation design services include the development of both medicated ointments (for infection, inflammation, and pruritus treatment) and non-medicated ointments (for use as emollients, protectants, and lubricants).
The high shear mixer can effectively reduce the particle size and improve the dissolution rate and bioavailability of the drug. The high pressure homogenizer and ultrasonic emulsifier are used to prepare the emulsion system in the ointment. The choice of method depends on the type of ointment (hydrophobic, hydrophilic or water-emulsified) and the characteristics of the API:
Fusion method
For ointments that need to be mixed with solid ingredients, use the fusion method, which is to melt the ingredients and then cool them while stirring to form a uniform ointment.
Trituration method
For heat-sensitive apis, the grinding method is used, where the drug is ground fine and mixed with the alkali without the need for heating.
Emulsification method
For water emulsified ointments, emulsification is used to mix the water phase with the oil phase. This is essential to obtain a stable emulsion and ensure that the ointment maintains its integrity over time.
Chemical reaction method
This method is used when the formation of the ointment requires a chemical reaction between the ingredients. It is particularly useful for complex formulations requiring precise interactions between components.
The laboratory is equipped with high performance liquid chromatograph, gas chromatograph, ion chromatograph, mass spectrometer and other high-end testing instruments, which can accurately and quantitatively analyze the active ingredients and degradation products in transdermal preparations.
Viscosity and texture analysis: Use precision rheometers to measure the ointment's viscosity, ensuring it has the right consistency for easy application and patient comfort.
Stability testing: Comprehensive stability tests are conducted under various environmental conditions (temperature, humidity, light exposure) to ensure the ointment remains effective throughout its shelf life.
Microbial testing: We conduct microbial content assessments and anti-corrosion tests to ensure that the ointments are safe for prolonged use and free from contamination.
In vitro release test (IVRT): This test measures the release rate of the active ingredient in the ointment over time. Vertical diffusion cell and Franz diffusion cell are commonly used test equipment.
In vitro transdermal test (IVPT): To simulate the transdermal process of drugs under physiological conditions and study the quality and effectiveness of clinical treatment. Using isolated skin of miniature pig or rat, receiving solution is water or buffer solution, no organic solvent is used. If necessary, add surfactants that have little effect on the skin. Pre-test decided more than 24 hours. The subsequent skin barrier status may change significantly.
1. What is the difference between ointments, creams, and lotions?
Ointments have the highest oil content, making them thicker and greasier. They form an occlusive barrier that helps retain moisture in the skin.
Creams have a balanced oil-water content, making them less greasy and easier to spread than ointments. They are ideal for moist skin conditions.
Lotions have the highest water content, making them light and easy to apply over large areas. They are often used for mild conditions and for cooling the skin.
2. What are the common uses of ointments?
3. What types of ointments can be developed?
BOC Sciences can help prepare various types of ointments:
Hydrophobic (oleaginous) ointments: Provide occlusive protection and moisture retention.
Water-emulsifying ointments: Allow absorption of water to form emulsions.
Hydrophilic (water-soluble) ointments: Non-greasy and easy to wash off. These ointments can be tailored for therapeutic purposes such as infection treatment, anti-inflammatory, and skin protection.
4. What does the ointment development process involve?
The development process typically includes:
Pre-formulation studies: Analyzing the active pharmaceutical ingredient (API) properties and excipient compatibility.
Formulation design: Creating a stable and effective formulation to meet therapeutic goals.
Stability testing: Ensuring product stability over time under various environmental conditions.
Scaling-up: Transitioning from lab-scale production to commercial-scale manufacturing.
5. What advanced technologies and equipment are used in ointment development?
Our ointment development services often use cutting-edge technology and equipment, including:
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