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Overview of drug solubilizer excipients, emulsifiers & lipid based vehicles, like vitamin E TPGS, used in topical & oral pharmaceutical formulations.
Solubilizer agents, such as surfactants, are solubilizer excipients added to pharmaceutical formulations in order to increase the solubility of poorly soluble drugs, thereby increasing the bioavailability of the corresponding active pharmaceutical ingredient (API). Solubility is defined as the extent to which a given solute can dissolve in a pharmaceutical solvent, to form a saturated, homogeneous solution at a fixed temperature.
The solubility of poorly water-soluble drugs is way below the desired threshold, which lowers their absorption in the gastrointestinal tract. Furthermore, poorly water soluble drugs have reduced drug efficiencies as compared to pharmaceutical formulations with appropriate solubility profiles and may cause undesirable side effects upon administration.
Drug formulators are trying to better understand the mechanism of action of poorly soluble drugs, both before and after the active pharmaceutical ingredient (API) is released from the dosage form to cope with these issues. However, studying the transformation of such formulations in a complex gastrointestinal environment is riddled with challenges.
The method to increase the solubility of poorly water soluble drugs in pharmaceutical solvents is known as solubilization. Solubilization is the process that enables solubility enhancement of poorly soluble drugs by preparing isotropic, thermodynamically stable solutions via the addition of solubilizer excipients (also called solubilizing agents) to solutions. Solubilization progresses in the following step:
Step 1: Breaking interionic or intermolecular bonds of solutes. Step 2: Separation of pharmaceutical solvents into freed up spaces to accommodate solutes. Step 3: Interactions between pharmaceutical solvents and solutes (ions or molecules).
Methods of solubility enhancement employed in the pharmaceutical industry include:
- Addition of co-solvents
- pH/temperature modifications
- Particle size reduction
- Addition of surfactants
- Complexation
- Solid dispersion techniques
- Solid state manipulations
- Pharmaceutical solvent deposition
- And various other processes.
Commonly used solubilizer agents for oral dosage forms and paediatric pharmaceutical formulations are listed below:
- Alcohols such as ethanol
- Sugars such as sorbitol
- Polyethylene glycols such as PEG-400
- Propylene glycol
- Cyclodextrins
- Sodium Lauryl Sulphates
- And copious other solubilizer agents.
Oral ingestion is the most convenient route of drug delivery and oral dosage forms are the most commonly employed pharmaceutical formulations due to ease of administration, high patient compliance, flexibility in the design of dosage forms, and cost effectiveness. However, the major challenge with the design of oral dosage forms lies within their poor bioavailability.
Oral bioavailability depends on several factors including aqueous solubility, drug permeability, dissolution rate, presystemic metabolism, and susceptibility to efflux mechanisms. The low solubility and dissolution rate of poorly water soluble drugs in aqueous gastrointestinal fluids often result in insufficient bioavailability of the corresponding APIs.
An insufficient solubility profile is one of the key factors responsible for reduced API (active pharmaceutical ingredient) bioavailability. Solubilizers or solubilizing agents enhance the bioavailability of oral dosage forms by increasing the solubility of poorly soluble drugs. These surface-active properties of solubilizing agents triggered the interest of drug formulation developers before it ultimately became a fixture in the toolbox of pharmaceutical drug delivery innovators.
Some commonly used solubilizer agents for pharmaceutical dosage forms are ethanol, sorbitol, polyethylene glycols, cyclodextrins, sodium lauryl sulphates, polysorbates , propylene glycol, etc. Furthermore, solubilizer excipients and co-solvents play a major role for the bioavailability enhancement of other dosage forms like parenteral formulations.
Solubilizing agents may also act as emulsifiers or emulsifying agents in the formulation of emulsion and self emulsifying drug delivery systems (SEEDS). Emulsifiers are used in pharmaceutical formulations to get stable emulsions to achieve the physico-chemical characteristics required for optimal delivery of API and absorption enhancement. Solubilizers such as polysorbates are used to solubilize oils in water and can be used in various topical formulations such as sprays, emulsion, creams, lotions, etc.
Solubilizer excipients or solubilizing agents used in oral formulations are classified into the following types, explored below.
1. Water Soluble Organic Lipids
- E.g. Propylene glycol, glycerin, ethanol, etc.
Lipid-based drug delivery systems (LBDDS) are one of the emerging technologies designed to address challenges like the solubility and bioavailability of poorly soluble drugs. Lipids act as vehicles for drug delivery and are combined with one or more surfactants and hydrophilic co-solvents to achieve solubility enhancement.
2. Non-ionic Surfactants
- E.g. Sorbitan monooleate, vitamin E TPGS (tocophersolan), etc.
Non-ionic surfactants are very useful as absorption enhancers as they improve the dissolution rate and permeability of drugs. Surfactants reduce surface tension and form colloidal aggregates called micelles; solubility increases as concentration of micelles (CMC) increases.
3. Water-insoluble Lipids
- E.g. Olive oil, peppermint oil, castor oil, etc.
Water insoluble lipids are insoluble in polar pharmaceutical solvents like water but highly soluble in the non-polar or weakly polar organic solvents, including ether, chloroform, benzene, and acetone. Water insoluble lipids, thus increase absorption and achieve solubility enhancement in non-polar pharmaceutical solvents also known as fat solvents.
4. Organic Liquids/Semi-solids
- E.g. Beeswax, d-alpha-tocopherol, etc.
Organic liquids and semi-solids are solubilizing agents or vehicles used to enhance the solubility of solids in the gastrointestinal tract. These lipid based drug delivery vehicles are employed in solid dispersion and solid state manipulation techniques of solubility enhancement.
5. Cyclodextrins
- E.g. alpha-cyclodextrin, beta-cyclodextrin, etc.
Cyclodextrins are used as solubilizing agents or complexing agents to increase the solubility, and consequently the stability, of poorly soluble drugs in aqueous solutions. They further reduce side effects and irritation in gastrointestinal systems, achieve odor and taste-masking, prevent drug drug or drug additive interactions, etc.
6. Phospholipids
- E.g. Hydrogenated soy phosphatidylcholine, l-alpha-dimyristoyl phosphatidylglycerol, etc.
Phospholipids are solubilizer agents/vehicles that are used in complexation techniques of solubilization. Drug-phospholipid complexes are considered ideal for oral delivery as they are biodegradable and non-toxic, which enable them to be employed as solubilizer excipients, emulsifying agents, and as matrix forming pharmaceutical excipients that increase the permeability and solubility of poorly water soluble drugs.
Solubilization enhancement is used in pharmaceutical drug delivery to increase the solubility, defined as the maximum concentration of solute that can be dissolved in a given amount of solvent, of formulations. It is achieved by manipulating factors that affect solubilization such as temperature, pressure, and particle size or by using solubilizer excipients (solubilizer agents).
- Temperature: Generally an increase in temperature results in an increase in the solubility of oral formulations. However, the opposite can also be true in case of gaseous formulations.
- Pressure: While changes in pressure have minimal or no effect on the solubility of solids and liquids, an increase in the pressure of gaseous solutes can facilitate solubility enhancement.
- Particle Size: Solubility increases as particle size decreases which leads to an increase in surface energy, however, there has to be a substantial reduction in size (<1 micrometer) for solubility enhancement to occur. Particle size reduction is usually achieved via micronization and nanoization technologies.
Poorly water soluble drug formulations are a major issue for the pharmaceutical industry. For solubility enhancement, there are various solubilizer excipients such as surfactants, lipids, cyclodextrins, etc. which can increase the bioavailability of active pharmaceutical ingredients (APIs) by increasing their solubility. Advanced solubility enhancing pharmaceutical excipients can accelerate the time it takes to bring pharmaceutical formulations to market. In aqueous-based solutions, solubilizers are used to modify the polarity of water to allow an increase in the solubility of a nonpolar drug.
In addition to solubility enhancement, some solubilizer excipients (for e.g. vitamin E TPGS/Tocophersolan) may also function as emulsifiers by enabling the formation of emulsion formulations. Emulsifying agents are soluble in both oil and water as one end of the molecule is attracted to water (hydrophilic) and the other end is attracted to fats/oils (lipophilic).
When a solubilizer is added to an oil and water product, one end of the molecule dissolves in water and the other dissolves in oil to form emulsion formulations, forcing these molecules to be near each other without separating, thereby acting as an emulsifier or an emulsifying agent . This push and pull of emulsifiers in oil and water keeps different substances suspended in a solution.
Surface active agents or emulsifying agents are added to emulsions to stabilize the dispersed and continuous phase by increasing the electrostatic repulsion or steric repulsion between them. Emulsifiers thus act on the interface and increase the kinetic stability of emulsions so that the size of the droplets do not change significantly with time.
Emulsion formulation is an essential process and is applied in the food industry to make butter, margarine, mayonnaise, etc. Many cosmetic and pharmaceutical dosage forms come in emulsion preparations, and chemical synthesis of glues, paints, and other polymer dispersions also utilizes emulsion formulation.
Poorly soluble drugs are a major issue for the pharmaceutical industry. By using solubility enhancement excipients pharmaceutical formulators can increase the bioavailability of active pharmaceutical ingredients (API). Advanced solubility enhancement excipients can help companies bring products to market faster.
There are various pharmaceutical companies that offer solubilizer excipients, including, but not limited to:
- PMC Isochem
(E.g. Vitamin E TPGS)
PMC Isochem offers Vitamin E TPGS or Tocophersolan, a water soluble derivative of natural Vitamin E, which is a multirole pharmaceutical excipient that functions as a solubilizer, plasticizer, vehicle for lipid based pharmaceutical formulations, binder, and as an emulsifier. Tocophersolan (Vitamin E-TPGS) has been approved by the FDA as a safe adjuvant and subsequently has been widely used in drug delivery systems.
- Gattefossé
(E.g. CapryolTM 90, Gelucire® 44/14, Labrasol® ALF, Labrasol®, etc.)
Gattefossé is a leading provider of lipid excipients and formulation solutions to healthcare industries worldwide. Their functional solubilizer excipients are designed to meet the most pressing formulation challenges in drug development; Poor solubility, permeability, and bioavailability, with lipid-based drug delivery systems consisting of single or multiple excipients.
- BASF North America
(E.g. Kolliphor EL, Kollidon VA 64, Soluplus, Kolliphor RH40, Kolliphor ELP, Kollisolv P 124, etc.)
Solubilization is an essential process that ideally results in crystal clear systems. The major challenge it poses is matching the lipophilic substance and the medium with the solubilizer. BASF’s comprehensive solubilizer portfolio allows customers to solubilize a wide range of lipophilic substances in different media, including water, alcohol and surfactant systems.
- ABITEC
(E.g. Captex 350 Glycerol Tricaprylate/Caprate/Laurate, Captex 200P, Caprol Polyglycerol Esters, etc.)
ABITEC develops and manufactures lipid-based excipients to enhance the bioavailability of poorly water-soluble and poorly permeable Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry.
- Roquette Pharma
(E.g. CRYSMEB, Glucono-Delta-Lactone, KLEPTOSE® 10, CLEARGUM® CO A1, etc.)
For several decades, formulators have trusted Roquette to help them overcome the challenge of API insolubility. Roquette offers versatile solubility enhancers that adapt to the demands of a formulations’ characteristics. Engineered to deliver functional reliability, their solutions deliver repeatable dissolution profiles batch after batch. No matter the drug characteristics or process strategy, they provide a range of products suited to enhance API solubility in oral dosage forms.
- SPI pharma
(E.g. Advantose 100)
SPI Pharma produces Advantose 100 solubilizer excipients. Advantose® 100 is a spray-dried maltose powder that provides excellent flow, solubility, & tableting properties for oral dosage formulations. Maltose is well known for its safety & mouthfeel qualities, especially in chewable tablets & lozenges. It is often used to achieve taste masking for tablets with undesirable taste profiles.
Applications:
Ingredient(s): Tocophersolan
Dosage Form: Capsule, Cream / Lotion / Ointment, Injectable / Parenteral, Ophthalmic Solution, Nasal Solution, Tablet
Category: Solubilizers
Technical Specifications: Specific Gravity: 1.06 at 50°C to 1.03 at 90°C; Solubility In Water: -20% at 20°C; Viscosity: 390cP at 50°C; Available in mol. wt. of 1500 g/mol, 200 g/mol, 2000 g/mol, 300 g/mol, 400 g/mol, 4000 g/mol.
Applications:
Ingredient(s): DHSM Excipient
Dosage Form: Cream / Lotion / Ointment
Category: Solubilizers
Technical Specifications: Purity of 97% or higher
Cophex 2024
Not Confirmed
Contact SupplierApplications:
Ingredient(s): Maltose Sugar
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polysorbate 80
Dosage Form: Cream / Lotion / Ointment
Category: Solubilizers
Technical Specifications: NA
Cophex 2024
Not Confirmed
Contact SupplierApplications:
Ingredient(s): Urea
Dosage Form: Cream / Lotion / Ointment
Category: Solubilizers
Technical Specifications: Not Available
Applications:
L-Lysine is widely used as a solubilizers in topical formulations such as cream, lotion & ointment.
Ingredient(s): L Lysine Excipient
Dosage Form: Cream / Lotion / Ointment
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): METHACRYLIC ACID COPOLYMER TYPE A
Category: Solubilizers
Technical Specifications: Available as powder; Other grades- EUDRAGIT® L 12,5
Applications:
Ingredient(s): Beta-Cyclodextrin
Category: Solubilizers
Technical Specifications: NA
Cophex 2024
Not Confirmed
Contact SupplierApplications:
Ingredient(s): Glycocholic Acid Excipient
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polyvinylpyrrolidone K12
Dosage Form: Capsule, Suspension, Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Sodium Oleate
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Benzyl Alcohol
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Cholesterol Excipient
Dosage Form: Cream / Lotion / Ointment
Category: Solubilizers
Technical Specifications: NA
Cophex 2024
Not Confirmed
Contact SupplierApplications:
Ingredient(s): Tartaric Acid
Dosage Form: Capsule, Granule / Pellet, Tablet
Category: Solubilizers
Technical Specifications: Bulk density: 0.8-1.1
Applications:
L-Lysine acetate is used as solubilizers in oral solid dosage forms such as capsules, tablets, etc.
Ingredient(s): L Lysine Acetate
Dosage Form: Capsule
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Sodium Deoxycholate Excipient
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Butylene glycol
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Sorbitan Laurate
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Methacrylic Acid - Ethyl Acrylate Copolymer
Dosage Form: Granule / Pellet, Tablet
Category: Solubilizers
Technical Specifications: Available as powder; Other grades- EUDRAGIT® L 30 D-55
Applications:
Ingredient(s): Hydroxypropyl Betacyclodextrin
Dosage Form: Capsule, Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: NA
Cophex 2024
Not Confirmed
Contact SupplierApplications:
Ingredient(s): Sorbitan Monostearate
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polyoxyl 20 Cetostearyl Ether
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): 2-Pyrrolidone
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Sorbitan Trioleate
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Egg Yolk Lecithin
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Ammonia Methacrylate Copolymer Type A
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Other grades- EUDRAGIT® RL 12,5, EUDRAGIT® RL 30 D, EUDRAGIT® RL PO
Applications:
Ingredient(s): Soya Lecithin
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Oleic Acid Excipient
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Ammonio Methacrylate Copolymer Type B
Category: Solubilizers
Technical Specifications: Available as granules; Other grades- EUDRAGIT® RS 12,5, EUDRAGIT® RS 30 D, EUDRAGIT® RS PO
Applications:
Ingredient(s): Tyloxapol
Category: Solubilizers
Technical Specifications: NA
Cophex 2024
Not Confirmed
Contact SupplierApplications:
Ingredient(s): sorbitan oleate
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Poloxamer 188
Dosage Form: Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
L-Lysine acetate is used as a solubilizer in capsules along with other oral solid dosage forms.
Ingredient(s): L-Lysine Acetate
Dosage Form: Capsule
Category: Solubilizers
Technical Specifications: Molecular weight: 206.24 g/mol
Applications:
Ingredient(s): Poloxamer 407
Dosage Form: Cream / Lotion / Ointment, Gel, Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polyoxyl 15 Hydroxystearate
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polyoxyl 35 Castor Oil
Dosage Form: Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polyoxyl 40 Hydrogenated Castor Oil
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polyoxyl 40 Stearate Excipient
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polyoxyl 60 Hydrogenated Castor Oil
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polysorbate 20
Dosage Form: Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polysorbate 60
Dosage Form: Cream / Lotion / Ointment, Gel
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Polysorbate 80
Dosage Form: Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Propylene Carbonate
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): Guanidine Hydrochloride
Dosage Form: Cream / Lotion / Ointment
Category: Solubilizers
Technical Specifications: Bio Excipient Grade
Applications:
Ingredient(s): Urea
Dosage Form: Cream / Lotion / Ointment
Category: Solubilizers
Technical Specifications: Bio Excipient Grade
Applications:
Tyloxapol excipient is used as an solubilizing agent in the ophthalmic products.
Ingredient(s): Tyloxapol
Dosage Form: Ophthalmic Solution
Category: Solubilizers
Technical Specifications: US DMF Available
Applications:
It is used as a suspending agent.
Ingredient(s): Carbomer Excipient
Category: Solubilizers
Technical Specifications: Not Available
Applications:
A&C’s Benzalkonium Chloride 17% is a preservative which meets the NF monograph.
Ingredient(s): Benzalkonium chloride excipient
Dosage Form: Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: 17% USP NF
Applications:
It is used as solubilizers for paclitaxel, cyclosporine, vitamin K1.
Ingredient(s): Polyoxyl 35 Castor Oil
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Sorbitan Monooleate (Span 80) is used as oily emulsifier, solubilizer, thickener.
Ingredient(s): Sorbitan Monooleate
Dosage Form: Capsule, Tablet, Transdermal patches
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubilizer, Dissolution Improver, Emulsifier, Masking Agent, Moisturizer, Aerosol Formulations
Ingredient(s): Polyoxyl 35 Hydrogenated Castor Oil
Dosage Form: Emulsion, Injectable / Parenteral, Solution, Suspension
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Nonionic solubilizer, emulsifier and co-emulsifier
Ingredient(s): Polysorbate 20
Dosage Form: Gel, Softgel Capsule, Solution, Suppository
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Polyethylene Glycol 4000
Dosage Form: Capsule, Cream / Lotion / Ointment, Emulsion, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Benzalkonium chloride excipient
Dosage Form: Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: 50% NF
Applications:
Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Ingredient(s): Polysorbate 20
Dosage Form: Capsule, Cream / Lotion / Ointment, Gel, Shampoo, Solution, Syrup, Tablet
Category: Solubilizers
Technical Specifications: HLB: 17, EO: 20; EXCiPACT
Applications:
Ingredient(s): Vinylpyrrolidone Excipient
Dosage Form: Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Betadex Sulfobutyl Ether Sodium Excipient
Dosage Form: Injectable / Parenteral, Ophthalmic Solution, Nasal Solution, Topical Film
Category: Solubilizers
Technical Specifications: Captisol® is a polyanionic beta-cyclodextrin derivative with a sodium sulfonate salt separated from the lipophilic cavity by a butyl ether spacer group, or sulfobutylether (SBE).
Applications:
Ingredient(s): Maltose Excipient
Dosage Form: Injectable / Parenteral
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Copovidone K25-31
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Polysorbate 80 acts as solubilizer, emulsifier and wetting agent.
Ingredient(s): Polysorbate 80
Dosage Form: Capsule, Suspension, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubilizing agents and Stabilizers.
Ingredient(s): Beta-Cyclodextrin
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubility enhancement, Spray-Dried Dispersion (SDD), Hot Melt Extrusion (HME)
Ingredient(s): Hydroxypropyl methylcellulose acetate succinate
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Nonionic solubilizer, emulsifier and co-emulsifier
Ingredient(s): Polysorbate 60
Dosage Form: Gel, Softgel Capsule, Solution, Suppository
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubility enhancement, Spray-Dried Dispersion (SDD), Hot Melt Extrusion (HME)
Ingredient(s): Hydroxypropyl Methylcellulose
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
A & C's Benzethonium Chloride USP is a hygroscopic excipient, which meets USP requirements.
Ingredient(s): Benzethonium Chloride Exc
Dosage Form: Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: 17% USP NF; 50% NF; USP
Applications:
Disintegrant; Dissolution enhancer; Suspending Agent, Tablet Binder.
Ingredient(s): Povidone
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Nonionic solubilizer, emulsifier and co-emulsifier
Ingredient(s): Polysorbate 80
Dosage Form: Gel, Softgel Capsule, Solution, Suppository
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Cetrimonium Bromide Excipient
Dosage Form: Injectable / Parenteral, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Trehalose
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Poloxamer 188
Dosage Form: Granule / Pellet, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Poloxamer 407
Dosage Form: Granule / Pellet, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubiliser, Plasticizer for coating & polymeric matrices, Nonionic emulsifier for O-W emulsions.
Ingredient(s): Polyoxyl Hydogenated Castor Oil
Dosage Form: Emulsion, Softgel Capsule
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Methacrylic Acid - Ethyl Acrylate Copolymer
Category: Solubilizers
Technical Specifications: NA
Applications:
Ingredient(s): sorbitan oleate
Dosage Form: Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral, Solution, Topical Film
Category: Solubilizers
Technical Specifications: Non-Ionic Lipophilic surfactant; Emulsifier (w/o emulsions)
Applications:
Ingredient(s): Maltose Excipient
Dosage Form: Granule / Pellet, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
A & C's Maltodextrin is an excipient which meets the NF monograph.
Ingredient(s): Maltodextrin Excipient
Dosage Form: Capsule, Granule / Pellet, Softgel Capsule, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
It provides solubility and viscosity stability on medium viscosity.
Ingredient(s): Carboxymethyl cellulose sodium
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Medium Viscosity
Applications:
Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Ingredient(s): Polysorbate 80
Dosage Form: Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Paste, Shampoo, Solution, Syrup, Tablet
Category: Solubilizers
Technical Specifications: HLB: 15, EO: 20; EXCiPACT
Applications:
It provides smooth solutions, based on uniform substitution with low viscosity.
Ingredient(s): Carboxymethyl cellulose sodium
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Low Viscosity
Applications:
Oil fill & solubilizer for lipophilic drugs, Water barrier-repairing, emollient film-former on skin
Ingredient(s): Medium Chain Triglycerides
Dosage Form: Emulsion, Softgel Capsule
Category: Solubilizers
Technical Specifications: Not Available
Applications:
It provides solubility and viscosity stability on strong high viscosity.
Ingredient(s): Carboxymethyl cellulose sodium
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Strong High Viscosity
Applications:
Ingredient(s): Polysorbate 20
Dosage Form: Capsule, Cream / Lotion / Ointment, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Non-Ionic Hydrophilic surfactant, Emulsifier (o/w emulsion), Solubilizer
Applications:
A & C's Polysorbate 20 is an excipient which meets the NF monograph.
Ingredient(s): Polysorbate 20
Dosage Form: Capsule, Cream / Lotion / Ointment, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Polysorbate 80
Dosage Form: Capsule, Suspension, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Povidone
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Also Available as Microlex® PVD K90.
Applications:
Ingredient(s): Propylene Glycol
Dosage Form: Emulsion, Softgel Capsule, Solution
Category: Solubilizers
Technical Specifications: Not Available
Applications:
A & C's Polysorbate 80 is an excipient which meets the NF monograph.
Ingredient(s): Polysorbate 80
Dosage Form: Capsule, Suspension, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Copovidone K25-31
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Polysorbate 80
Dosage Form: Capsule, Cream / Lotion / Ointment, Tablet
Category: Solubilizers
Technical Specifications: Non-Ionic Hydrophilic surfactant, Emulsifier (o/w emulsion), Solubilizer
Applications:
It facilitates to facilitate the dissolution of poorly API due to porous surface morphology.
Ingredient(s): Crospovidone
Dosage Form: Tablet
Category: Solubilizers
Technical Specifications: Also Available as Microlex® Cr.PVD CL-25, Microlex® Cr.PVD UCL-25, Microlex® Cr.PVD UCL-110
Applications:
Solvent for injectables and oral formulations for animal health
Ingredient(s): Pyrrolidone
Dosage Form: Emulsion, Solution
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Crospovidone
Category: Solubilizers
Technical Specifications: Crospovidone (Type-A/B)- USP-NF / Ph. Eur. / BP / IP
Applications:
Ingredient(s): Pea Maltodextrins
Dosage Form: Capsule, Softgel Capsule, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubilizer, Dissolution Improver, Emulsifier, Masking Agent, Moisturizer, Aerosol Formulations
Ingredient(s): Polyoxyl 50 Hydrogenated Castor Oil
Dosage Form: Dry Syrup, Emulsion, Nasal Solution, Solution, Suspension, Syrup
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Enteric, Delayed Release Matrix and Solubility Enhancement
Ingredient(s): Methacrylic Acid - Ethyl Acrylate Copolymer
Category: Solubilizers
Technical Specifications: Methylacryli acid and Ethyl Acrylate copolymer (1:1) Type A
Applications:
Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Ingredient(s): Polysorbate 20
Dosage Form: Injectable / Parenteral, Ophthalmic Solution, Nasal Solution
Category: Solubilizers
Technical Specifications: EXCiPACT
Applications:
Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Ingredient(s): Polysorbate 80
Dosage Form: Injectable / Parenteral, Ophthalmic Solution, Nasal Solution
Category: Solubilizers
Technical Specifications: EXCiPACT
Applications:
Co-emulsifier, viscosity enhancer & anti-tacking agent
Ingredient(s): Glyceryl Monostearate With Mono & Di Glycerides
Dosage Form: Cream / Lotion / Ointment, Emulsion, Gel, Softgel Capsule
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Ingredient(s): Polysorbate 80
Dosage Form: Injectable / Parenteral, Ophthalmic Solution, Nasal Solution
Category: Solubilizers
Technical Specifications: EXCiPACT
Applications:
Ingredient(s): Carbomer Homopolymer Type A
Dosage Form: Suspension, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Ingredient(s): Polysorbate 80
Dosage Form: Injectable / Parenteral, Ophthalmic Solution, Nasal Solution
Category: Solubilizers
Technical Specifications: EXCiPACT
Applications:
Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Ingredient(s): Polysorbate 80
Dosage Form: Injectable / Parenteral, Ophthalmic Solution, Nasal Solution
Category: Solubilizers
Technical Specifications: EXCiPACT
Applications:
Ingredient(s): Carbomer Homopolymer Type A
Dosage Form: Emulsion
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Carbomer 941
Dosage Form: Suspension, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Macrogol 8 Stearate
Dosage Form: Cream / Lotion / Ointment, Topical Film
Category: Solubilizers
Technical Specifications: Emulsifying surfactant
Applications:
Ingredient(s): Macrogol 40 Stearate
Dosage Form: Cream / Lotion / Ointment, Topical Film
Category: Solubilizers
Technical Specifications: Emulsifying Surfactant
Applications:
Solubilizer, dissolution improver, emulsifier, masking agent, moisturizer, aerosol formulations.
Ingredient(s): Polyoxyl 40 Hydrogenated Castor Oil
Dosage Form: Emulsion, Injectable / Parenteral, Solution, Suspension
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Sorbitan Monostearate
Dosage Form: Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral, Topical Film
Category: Solubilizers
Technical Specifications: Non-Ionic Lipophilic surfactant; Emulsifier (w/o emulsions)
Applications:
Hard fat for suppository matrix, viscosity enhancer
Ingredient(s): Hard fat
Dosage Form: Suppository
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Hard fat for suppository matrix, viscosity enhancer
Ingredient(s): Hard fat
Dosage Form: Suppository
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Hard fat for suppository matrix, viscosity enhancer
Ingredient(s): Hard fat
Dosage Form: Suppository
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubilizer, dissolution improver, emulsifier, masking agent, moisturizer, aerosol formulations.
Ingredient(s): Polyoxyl 60 Hydrogenated Castor Oil
Dosage Form: Dry Syrup, Emulsion, Nasal Solution, Solution, Suspension, Syrup
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Hard fat for suppository matrix, viscosity enhancer
Ingredient(s): Hard fat
Dosage Form: Suppository
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Sorbitan Monolaurate
Dosage Form: Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral
Category: Solubilizers
Technical Specifications: Non-Ionic Lipophilic Surfactant; Emulsifier (w/o emulsions)
Applications:
Ingredient(s): Polysorbate 60
Dosage Form: Capsule, Cream / Lotion / Ointment, Tablet
Category: Solubilizers
Technical Specifications: Non-Ionic Hydrophilic surfactant, Emulsifier (o/w emulsion), Solubilizer
Applications:
Ingredient(s): Polyoxyl 40 hydrogenated castor oil
Dosage Form: Capsule, Dry Syrup, Tablet
Category: Solubilizers
Technical Specifications: Solubilizer in powder form; EXCiPACT
Applications:
Solstab 407 acts as a solubiliser, gelling agent, dispersing agent, lubricant and wetting agent.
Ingredient(s): Poloxamer 407
Dosage Form: Injectable / Parenteral, Ophthalmic Solution, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Versatile excipient having multitude uses in Pharma, Nutra, Cosmetic, Automobile etc
Applications:
Ingredient(s): Polysorbate 80, Polysorbate 80
Dosage Form: Capsule, Dry Syrup, Tablet
Category: Solubilizers
Technical Specifications: Solubilizer in powder form; EXCiPACT
Applications:
Ingredient(s): Maltose Sugar
Dosage Form: Solution
Category: Solubilizers
Technical Specifications: Maltose is a reducing disaccharide consisting of two glucose molecules linked by an ?-1,4 bond.
Applications:
Ingredient(s): Hydroxypropyl Beta-Cyclodextrin
Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Suspension, Syrup, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Magnesium aluminium silicate Excipient, Polysorbate 80
Category: Solubilizers
Technical Specifications: Solubilizer in powder form, used in directly compressible dosage forms, Wet granulation, added during lubrication stage
Applications:
Polyoxyl 40 hydrogenated castor oil is used as solubilizer and emulsifying agent.
Ingredient(s): Magnesium Aluminometasilicate, Polyoxyl 40 Hydrogenated Castor Oil
Category: Solubilizers
Technical Specifications: Solubilizer in powder form, used in Directly compressible dosage forms, Wet granulation, added during lubrication stage
Applications:
Ingredient(s): Hydroxypropyl Beta-Cyclodextrin
Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Suspension, Syrup, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Crospovidone, Povidone
Category: Solubilizers
Technical Specifications: PVP K-K-30/ K-17/ K19/ K25/ K90
Applications:
Nonionic emulsifier for O-W emulsions
Ingredient(s): Macrogol Cetostearyl Ether
Dosage Form: Cream / Lotion / Ointment, Emulsion, Gel
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Nonionic emulsifier for O-W emulsions
Ingredient(s): CETEARETH-12, Polyoxyl 20 Cetostearyl Ether
Dosage Form: Cream / Lotion / Ointment, Emulsion, Gel
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Nonionic emulsifier for O-W emulsions, Solubilizer
Ingredient(s): Polyoxyl 15 Hydroxystearate
Dosage Form: Emulsion, Gel, Softgel Capsule, Solution, Suspension
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Nonionic emulsifier for O-W emulsions, Solubilizer
Ingredient(s): Polyoxyl 35 Castor Oil
Dosage Form: Capsule, Emulsion, Gel, Solution, Transdermal patches
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Poloxamer 188
Dosage Form: Capsule, Emulsion, Gel, Solution, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Ingredient(s): Povidone
Dosage Form: Capsule, Tablet, Transdermal patches
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Polyethylene Glycol 400
Dosage Form: Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Solution, Tablet
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Poloxamer 407
Dosage Form: Emulsion, Gel, Solution, Suspension
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Poloxamer 338
Dosage Form: Emulsion, Gel, Solution
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Povidone
Dosage Form: Softgel Capsule, Suspension
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubility and bioavailability enhancement, ideal for hot melt extrusion (HME)
Ingredient(s): polyethylene glycol, Polyvinyl Acetate
Dosage Form: Solution
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Polyethylene Glycol 300
Dosage Form: Emulsion, Gel, Solution
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Ingredient(s): Poloxamer 124
Dosage Form: Emulsion
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products
Ingredient(s): Povidone
Dosage Form: Capsule, Emulsion, Softgel Capsule, Solution, Tablet, Transdermal patches
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products
Ingredient(s): Povidone
Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Solution, Tablet, Transdermal patches
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Hydrophilic fill for solubilization of hydrophilic APIs.
Ingredient(s): Polyethylene Glycol 600
Dosage Form: Softgel Capsule
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Ingredient(s): Beta-Cyclodextrin
Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Suspension, Syrup, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Ingredient(s): Beta-Cyclodextrin
Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Suspension, Syrup, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Ingredient(s): Beta-Cyclodextrin
Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Suspension, Syrup, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Ingredient(s): Beta-Cyclodextrin
Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Suspension, Syrup, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Ingredient(s): Beta-Cyclodextrin
Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Suspension, Syrup, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Not Available
Applications:
Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Ingredient(s): Beta-Cyclodextrin
Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Suspension, Syrup, Tablet, Topical Film
Category: Solubilizers
Technical Specifications: Not Available
