BOC Sciences is a leading biopharmaceutical and chemical research services company dedicated to supporting customers from drug development to manufacturing. Through our expertise, state-of-the-art facilities and research capabilities, we provide pharmaceutical companies and research institutions with comprehensive gel development services.
Gel refers to the thick liquid or semi-solid preparation with gel characteristics made of the raw material and the excipients that can form gel. The gel used in pharmaceutical preparation has the advantages of abundant drug load, lasting effect and easy removal, and is a common external drug dosage form. Gels can be classified as topical gels and topical gels. According to different routes of administration, topical gels can be further divided into skin gels, eye gels, vaginal gels, rectal gels, etc.
The matrix of the gel is a single-phase dispersion system, which can be divided into water-based matrix and oil-based matrix. The water-based gel matrix is generally composed of polymer materials and water, and in order to ensure the wettability of the preparation, it is usually necessary to add polyols as moisturizing agent. The oily gel matrix is composed of liquid paraffin or fat oil and colloidal silicon or aluminum soap and zinc soap. Because the aqueous matrix has strong hydrophilic ability and high affinity with the human body environment, it can effectively improve the drug release efficiency and prevent the deposition of tissue exudate, so it has the advantage of good compliance in clinical application.
Enhanced drug absorption: Gels offer far better bioavailability than forms of common delivery. Since the drug is able to penetrate more readily, absorption is greatly increased, and that is what leads to better outcomes and far more effective treatments.
Patient compliance: Their non-greasy texture helps to enhance drug delivery through the skin, which is an important pathway for topical drug delivery and increases patient compliance.
Extended drug release: Gels can also be formulated to delay drug release to prolong the time window of the therapy, making them well suited to many drug regimens that require long-term application.
Stability: Thick consistency of gel helps to increase the stability of the formulation and both hydrophilic and lipophilic drugs tend to have better shelf life in a gel (for example, they were less likely to be degraded by light) than if left in solution.
The commonly used excipients for local skin gels include gel matrix, pH regulator, humectant, preservative, stabilizer, co-solvent, solubilizer and transdermal absorption enhancer. Among them, the choice of gel matrix is particularly important in the development of gel formulation. Hydroxypropyl cellulose, sodium carboxymethyl cellulose, carbomer, acrylamide/acrylyl dimethyltaurine sodium copolymer, hydroxyethyl cellulose, xanthan gum, sunflower oil are commonly used gel substrates.
BOC Sciences considers whether an aqueous or organic system will better stabilize the drug and deliver it effectively to the target site. Depending on the drug's properties, natural polymers (e.g., gelatin), synthetic polymers, or organogels may be used.
BOC Sciences employs several complex methods in the preparation of the gel:
Grinding: Used for fine dispersion of water-insoluble drugs into a gel matrix.
Melting: The raw material is dissolved by heating and then cooled to form a gel structure.
Chemical reactions: Some gels are formed through chemical crosslinking, ensuring a stable substrate for drug delivery.
The development of gel formulations for pharmaceutical applications demands a meticulous approach in optimizing drug release properties, viscosity, stability, and user-friendliness to enhance drug stability and effectiveness. BOC Sciences tailors custom gel formulations based on the intrinsic properties of the active pharmaceutical ingredient (API) to meet these goals. The formulation process encompasses diverse gel types: water-based, oil-based, emulsified, and nanogels , each selected for its unique advantages.
Once the formula is determined, the next step is to debug and optimize the production process to ensure consistency of product quality and feasibility of production. This phase covers the transition from lab-scale pilot production to pilot production. Focus on improving process stability, repeatability of production and adaptability of equipment, and perform comprehensive process validation studies.
BOC Sciences offers a full range of analytical services to ensure the quality and safety of gel products throughout their life cycle. The main analytical services include: physical stability testing, chemical stability testing, microbial limit inspection and active ingredient content determination. In addition, gels are tested for rheological properties, formability, cold flow, adhesion (initial adhesion, holding adhesion), in vitro release test (IVRT) and in vitro transdermal test (IVPT). The stability test of the formulation process development stage includes: centrifugal test, cold/heat resistance test, influence factor test (high temperature, high humidity, light, low temperature, freeze-thaw, etc.), accelerated test.
After the small prescription process is determined, the laboratory small test should be scaled up, and the batch should be at least 3 batches. Optimize the key process parameters on the small scale amplification equipment, and investigate the durability of the process, do a good job in the control of the intermediate, and focus on the amplification effect. Then BOC Sciences seamlessly scales up production from lab-scale formulations to commercial-scale manufacturing, ensuring consistency in quality and performance.
High-shear mixers, ultrasonic mixers, high-precision colloid mills and ultrasonic emulsification equipment ensure uniform distribution of gels and precise particle size control, thereby improving drug stability and bioavailability. The precise temperature control system supports experiments in multiple temperature ranges to meet the preparation needs of different types of gels.
Rheometers are used to monitor the physical properties of gels in real time and adjust formulation and process parameters to optimize drug properties.
High performance liquid chromatography (HPLC), gas chromatography (GC), and ultraviolet spectrophotometers are used for precise quantitative analysis of pharmaceutical ingredients to ensure a high degree of consistency in product quality.
Modern spectral techniques such as Raman spectroscopy and infrared spectroscopy are also used to monitor the molecular structure and composition changes of gels.
1. What are pharmaceutical gels?
A pharmaceutical gel is a semi-solid dosage form containing a drug, usually consisting of a base gel matrix and an active ingredient. They are used topically to achieve systemic or local therapeutic effects.
2. What types of pharmaceutical gels can BOC Sciences develop?
BOC Sciences can develop several types of pharmaceutical gels, including:
Hydrogels: Water-based gels suitable for water-soluble drugs
Organogels: organic solvent-based gels used in oil-soluble drugs
Natural polymer gels: Drugs made using natural polymers such as gelatin or chitosan that are suitable for specific biocompatibility needs
3. What are the application ways of pharmaceutical gels?
Pharmaceutical gels can be used in a variety of ways, including:
Apply topically to skin, eyes, or mucous membranes (e.g., mouth, nose, vagina, rectum)
The injectable form acts as a long-acting drug delivery system
Oral administration as a delivery system for specific drugs
4. How to ensure the formula stability of pharmaceutical gels?
BOC Sciences ensures the long-term stability of pharmaceutical gels through rigorous stability testing. All formulations are tested under controlled temperature and humidity conditions to simulate the environment in which the product is stored and used.
5. Can you handle large-scale gel production?
Yes, BOC Sciences has the facilities and technical expertise to scale production from laboratory samples to commercial-scale batches, ensuring uniformity in product quality.
6. What testing is performed on gel formulations?
BOC Sciences conducts a series of tests including viscosity measurements, stability studies, and drug release profiling to ensure that the gel meets the desired specifications.