As a company focused on the development of pharmaceutical formulations, BOC Sciences is committed to providing a full range of solution formulation research and development services to help customers from initial proof of concept to commercial production. We offer customized solutions for APIs with different properties, taking into account the complexity of solubility, stability and absorption.
Solution formulation is the solid, liquid or gaseous drug dissolved in a suitable solvent to form a uniform solution. Water is the most commonly used solvent, due to its non-toxic, odorless, high absorption rate, can also fuse polar and non-polar drugs. In some cases, alcohol, glycerin, or vegetable oil are also used as solvents, especially when increasing the solubility of the drug is required or water is not suitable as a solvent. This dosage form is widely used in the medical field because of its many advantages, such as rapid onset, easy absorption, and easy use. Solution dosage forms are commonly used for oral, injection, local applications and other routes of administration.
Active ingredient is the core ingredient of the drug solution and directly affects its efficacy. Active ingredients may be natural or synthetic chemicals that are used to target specific diseases or symptoms.
A solvent, usually water, alcohol, or other suitable solution, is used to dissolve or suspend the active ingredient so that it is easily absorbed.
In order to extend the shelf life of the drug and prevent the growth of microorganisms, some preservatives are often added.
Stabilizers and solubilizers are used to improve the solubility and stability of active ingredients to ensure lasting efficacy.
Odorants and colors are used to improve the taste and appearance of drugs, especially in children.
Rheological modifiers, such as cellulose derivatives, alginic acid and polyvinylpyrrolidone, control the flow characteristics of the solution, ensuring that it remains uniform over time and is easy to distribute.
Antioxidants such as sodium formaldehyde hyposulfate, butylanisole (BHA), and butylhydroxytoluene (BHT) help protect apis from environmental factors that can cause instability.
Buffers (such as citrate buffers) adjust the pH of the solution, ensuring that the API remains in its most stable form. At BOC Sciences, we carefully design buffering systems that not only stabilize the API, but also minimize any irritation or discomfort during dosing.
Immediate availability for absorption: One of the greatest advantages of solution dosage forms is their immediate availability for absorption. Since the API is already dissolved in the solution, it bypasses the dissolution phase required for solid forms, allowing for rapid onset of action. This is particularly beneficial for medications requiring quick relief, such as analgesics or antihistamines.
Flexible dosing: Solutions offer flexible dosing, allowing for precise adjustments based on the patient's needs. Unlike tablets or capsules, where the dose is fixed, solutions can be measured by volume, providing customizable dosing options. This is especially important in pediatric or geriatric populations, where dosing may need to be tailored to individual patient requirements.
Versatile absorption routes: Pharmaceutical solutions can be formulated for various absorption routes, including oral, parenteral, rectal, topical, and ophthalmic administration. This versatility makes them suitable for a wide range of therapeutic applications, from simple cough syrups to complex intravenous infusions.
Ease of administration: Solutions are often easier to administer compared to solid forms, particularly for patients who have difficulty swallowing pills, such as infants, the elderly, or patients with certain medical conditions. This makes them a preferred dosage form in pediatric and geriatric care.
Stability and homogeneity: Unlike suspensions, solutions provide stability and homogeneity, as the API is fully dissolved in the solvent. This eliminates the need for shaking the container and ensures that each dose contains an equal amount of the active ingredient, reducing the risk of underdosing or overdosing.
Evaluate the basic properties of the drug and determine the appropriate solvent type. This phase includes initial testing of the drug's solubility, as well as identification of potential stability issues.
Design possible solution formulations based on the results of preliminary studies. This process takes into account the effectiveness, safety and convenience of the drug, while ensuring the stability and shelf life of the solution.
In order to ensure the consistency and quality of pharmaceutical solutions, BOC Sciences provides analytical method development and validation services to develop stable and reproducible assays for the analysis of active pharmaceutical ingredients and their degradants in solutions. These methods include high performance liquid chromatography (HPLC), mass spectrometry (MS) and other suitable analytical techniques to ensure the quality control of the drug throughout the development and production process. Rigorous analytical testing is employed to monitor critical parameters such as solubility, pH stability, and viscosity.
This includes accelerated aging tests, long-term stability tests, and stability assessment under stress conditions to ensure the effectiveness and safety of the formulation throughout its shelf life.
Design and perform preclinical trials to evaluate the absorption, distribution, and clearance properties of drug solutions in animals. These studies provide customers with pharmacokinetic data on drug solution dosage forms, helping them optimize formulations to improve drug efficacy.
Once the formulation has been developed and validated, we offer seamless scaling and technology transfer services. Our team ensures that the process is repeatable and can be efficiently scaled to commercial production. This includes:
Pilot batch production: A pilot batch is created to evaluate the production process before full-scale production.
Technology transfer: Assisting customers in transferring developed formulations to their production facilities.
1. Can you help with regulatory submissions for our solution product?
Yes, we provide full regulatory support throughout the development process. Our team assists with the preparation of regulatory documentation for submissions such as INDs, NDAs, and ANDAs, ensuring compliance with FDA, EMA, and other relevant regulatory agencies.
2. What analytical methods are used to test the quality of the solutions?
We use a variety of advanced analytical methods, including High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), Dissolution Testing, and other relevant techniques to ensure the quality, purity, and consistency of our formulations.
3. Can you customize solutions for specific therapeutic applications?
Yes, our team is highly experienced in customizing solutions to meet the specific needs of different therapeutic applications. Whether it's improving solubility, enhancing bioavailability, or creating patient-friendly formulations, we tailor our approach to each project.
4. What factors should be considered in the development of solution?
When developing solution dosage forms, it is necessary to consider the solubility, stability, pH, osmotic pressure of the drug and the choice of preservatives. Developers also need to consider the formulation's safety, efficacy, and patient acceptance of the drug.
5. How to improve the solubility of drugs?
The methods to improve the solubility of drugs include choosing suitable solvents, using co-solvents, adding surfactants or using clathrate technology. Solubility is also sometimes enhanced by adjusting the pH of the solution or by making it into a salt form.
6. How to guarantee the stability of the drug solution?
Drug stability is a key problem in solution formulation development. Stability can be enhanced by adding stabilizers, preservatives, antioxidants, controlling the storage environment (e.g. temperature, light), and optimizing packaging materials.
7. What are the key steps in the quality control of solution forms?
Quality control includes quality testing of raw materials, formulation optimization, process validation, stability testing of the final product and, most importantly, ensuring the clarity and sterility of the solution.