The latest news, announcements and press releases from Formulationbio.
Formulation development is of paramount importance for new drug development as it can determine patentability, lifecycle and, ultimately, the success of a pharmaceutical product. Fully aware of the challenges that may arise from this process, Formulationbio recently announces that it now provides a comprehensive range of formulation development and analytical services for the pharmaceutical industry.
“Pharmaceutical formulation development is an indispensable step that makes the new drug substance being discovered gradually develop into a commercial drug product,” commented a senior scientist from Formulationbio. The scientist responsible for drug formulation must determine the most appropriate administration route to achieving effective drug delivery, and then optimize the formulation’s characteristics while taking into consideration the drug product’s bioavailability and processing requirements.
According to statistics, only 10% of new drug products in preclinical formulation development successfully reach the market. Therefore, Formulationbio provides the following four services to assist pharmaceutical companies conduct their drug formulation projects.
To guarantee the dosage forms are stable and safe and has good bioavailability, preformulation is needed, which investigates the physical and chemical properties of a drug substance when used alone or combined with excipients. Formulationbio can provide tailored preformulation analysis services, covering Crystallinity Determination, Amorphous Content Determination, Hygroscopicity Evaluation, Particle Size Analysis, Moisture Content Determination, Solubility Analysis, LogP/LogD/pKa Analysis, Stability Analysis, API-Excipient Compatibility, etc.
A large suite of formulation development services are offered at Formulationbio, that covers: Solids Dosage Forms Development (such as tablets, capsules, granules, pellets and powders), Semi-solids Dosage Forms Development (such as ointments, gels, suppositories, creams), and Liquids Dosage Forms Development (such as solutions, drops, nasal sprays, injections).
To ensure the drug meets the regulatory requirements, drug analysis is necessary during which process physical, chemical, or biological methods are used to test and analyze different dosage forms of drugs. Formulationbio provides the following drug analytical services: Disintegration Test, Dissolution Test, Tablet Hardness Test, Tablet Fragility Test, Elemental Impurities Analysis, Residual Solvents Test, Dosage Units Uniformity Test, Bioavailability/Bioequivalence Detection, Microbial Limits Test, Particulate Matter Test, Extractables & Leachables Test, etc.
In cases where traditional excipients are unable to meet market demand, some novel excipients need to be manufactured to meet the special needs of pharmaceutical market. Formulationbio provides customized services of multi-functional excipients or co-processing excipients, either through modification of a known excipient as a derivative or via the creation of a new chemical entity without base structure.
For more related information, please visit: https://www.formulationbio.com/services.html.
Staffed with a group of pharmaceutical experts, including Chemists, Biochemists, Engineers, and highly qualified operators, Formulationbio not only supplies a wide range of excipients, but also works closely with the pharmaceutical industry as a contract service organization, offering outstanding expertise to handle complex pharmaceutical formulation.
Excipients are of vital importance in the process of drug development. A good choice of excipient can lead to the formulation of stable dosage forms. To better meet the increasing demand for excipients, Formulationbio supplies a wide range of excipients for different research purposes, including binders, lubricants, diluents, disintegrants, emulsifiers, plasticizers, surfactants, sweeteners, fillers, stabilizers and so on.
An excipient is any component, other than the active substance, present in a medicinal product or used in the manufacture of the product. They have multiple functions and often act as a carrier for the active substance.
“As a leading manufacturer of excipients, Formulationbio has served the pharmaceutical industry for years. We launch varieties of excipients to help improve the performance of our clients’ drug products. The pharmaceutical excipients we developed and produced can be used for solid, semi-solid and liquid dosage forms,” says a spokesperson from Formulationbio. “In addition, we can provide custom pharmaceutical excipients services, such as preformulation, formulation and analytical testing of excipients, to address the needs and formulation challenges of our customers.”
The excipients provided at Formulationbio include, but are not limited to:
Binder excipients are formulated to act as an adhesive to bind together dry ingredients such as powders and granules. They can also give volume to low active dose tablets. Some of the binder excipients provided by Formulationbio are: Cellactose 80, KG Grade Microcrystalline Cellulose, UF Grade Microcrystalline Cellulose, Formulationbio 720 for Direct Compression, etc.
Disintegrants are excipients used to enhance the disintegration process of tablet formulation when they make contact with GIT fluid. Some of the disintegrant excipients provided by Formulationbio are: Ludiflash, Primellose Croscarmellose sodium, Primojel Sodium starch glycolate, Solani Amylum Native potato starch, SuperStarch 200 Partly pregelatinised maize starch and more.
Filler excipients are used to increase the volume of the material to enable easier processing of the ingredients and make it into a size suitable for consumption. Also, they can stabilize the product and help during manufacturing.
Lubricant excipients such as RetaLac and Colloidal Silicon Dioxide can decrease friction between the pharmaceutical formulations particles and the tableting equipment contact surfaces.
Sweetening agent excipients are substances that sweeten and mask the taste of food, beverages, and medications to make them palatable to the consumer. To name a few here: Tablettose 100, Tablettose 70, Dextrose anyhdrous C, Dextrose monohydrate GC, Glucose syrups, HI-SWEET 42 High Fructose Corn Syrup, HI-SWEET 55 High Fructose Corn Syrup, LYCASIN 75/75 HBC Maltitol Syrup.
Coating Systems Excipients
Coatings are added to tablets to help make large, difficult to swallow pills easier to take. They also have other benefits, for example, to prevent deterioration from water and moisture and to allow for breakdown in a specific organ in the body. Some of the coating systems excipients provided by Formulationbio are: CELPHERE MCC Spherical Seed Core, SWELSTAR Pregelatinized Starch NF MX-1(Sustained release matrix agent), Anhydrous Glycerol, Dibutyl Sebacate, METHOCEL Premium CR Cellulose Ether, and VIVACOAT A - Ready-to-Use Coating System.
In addition to the above-mentioned excipients, Formulationbio also offers emulsifier excipients, lipid excipients, taste masking excipients as well as other types of excipients for pharmaceutical research. For more information, please visit: https://www.formulationbio.com/products.html.
Staffed with a group of pharmaceutical experts, including Chemists, Biochemists, Engineers, and highly qualified operators, Formulationbio not only supplies a wide range of excipients, but also works closely with the pharmaceutical industry as a contract service organizations, offering outstanding expertise to handle the most complex formulations.
Excipients play an indispensable role in the process of pharmaceutical preparation. Disintegrants are added to a formulation to promote the drug release. To make disintegrant excipients easily accessible for scientists and researchers, Formulationbio recently announced that it now provides a wide range of disintegrant excipients that are frequently used in pharmaceutical research.
The disintegrants allow the fast breakdown of the dosage form in the stomach upon ingestion. The underlying mechanism of action is that: once coming into contact with moisture such as water, disintegrants will help tablet formulation to rapidly break up.
Disintegration is the de-aggregation of particles within tablets upon exposure to aqueous fluids and it is typically viewed as the first step in the dissolution process.After that, the active pharmaceutical ingredient becomes bioavailable and is readily absorbed. There are two classes of disintegrants, namely, traditional disintegrants and super disintegrants. The most popular and commonly used super disintegrants are: croscarmellose sodium, crospovidone, and sodium starch glycolate.
The disintegrant excipients provided at Formulationbio include (just to name a few here):
KICCOLATE Croscarmellose Sodium, PC-10 Pregelatinized Starch, Ludiflash, Primellose Croscarmellose sodium, Primojel Sodium starch glycolate, Solani Amylum Native potato starch, SuperStarch 200 Partly pregelatinised maize starch, CD - Sodium Starch Glycolate, RetaLac, Tablettose 100, Extra white maize starch, Maize Starch, CD Flash mannitol-starch for orodispersable tablets, Potato Starch, STARLAC lactose-starch, STARLAC lactose-starch compound, Wheat Starch TB and many more.
In addition to disintegrant, Formulationbio also offers binder excipients, filler excipients, lubricant excipients, sweetener excipients, coating systems excipients, emulsifier excipients, lipid excipients, taste masking excipients, solubilizer excipients, active pharmaceutical ingredient excipients, carrier excipients, compaction excipients, dry powder inhalation excipients as well as other types of excipients for pharmaceutical research. For more information, please visit: https://www.formulationbio.com/products/disintegrant-excipients.html.
Staffed with a group of pharmaceutical experts, including Chemists, Biochemists, Engineers, and highly qualified operators, Formulationbio not only supplies a wide range of excipients, but also works closely with the pharmaceutical industry as a contract service organization, offering outstanding expertise to handle complex formulations.
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