Below you will find the ingredients and excipients that we used in Vitex Formulas:
Carrageenan is a general name for polysaccharides extracted from certain kinds of algae which are built up, in contrast to agar, from D-galactopyranose units only. The word carrageenan is derived from the colloquial Irish name for this seaweed, carrageen (from the Irish placename, probably Carrigeen Head in Co. Donegal; the Irish word Carraigín means "little rock" and is a very common placename in Ireland) the use of this seaweed to extract a gel is known in Ireland since 1810. Chondrus crispus used to be the sole source of carrageenan, but sources now include Kappaphycus alvarezii (kappa carrageenan), Eucheuma denticulatum (iota carrageenan), Chondrus crispus (kappa & lambda carrageenans), and Sarcothalia crispata (kappa & lambda carrageenans). Modern carrageenan is a branded product designed, by mixing various types of carrageenan, to give a gel with particular qualities. Most of the Chondrus that is used in the carrageenan industry comes from the Maritime Provinces of Canada (Nova Scotia etc.), where about 35,000 wet t of C. crispus are harvested each year from natural populations. The bulk of the harvest is collected using long-handled rakes and dredges from small boats. The seaweed is then dried, either by spreading and air-drying or by using rotary dryers, and exported to the USA and Denmark for processing. Some processing now takes place in the Philippines, particularly of PGC ("Philippines Grade Carrageenan).
Carrageenan is used in processed foods for stabilization, thickening, and gelation. It has been successfully used by the food industry in the US since the 1950s, and with increasing demand driven by the consumers' need for convenience, appealing food textures, advances in food processing, and new food products. It is used worldwide to enhance ice creams, chocolate milk, custards, cheeses, jellies, confections, meats, and protein drinks. Carrageenan is an approved food additive.
Is Carrageenan Safe?
You may see references in magazines and on the Internet that caution consumers against the consumption of carrageenan due to concerns about the potential for gastrointestinal effects (including malignancies). These cautions were based on the conclusions of a literature review by Dr. Joanne Tobacman and published in Environmental Health Perspectives in October 2001. Recent information has been published by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) that should allay your concerns about the consumption of carrageenan.
Overall, the JECFA concluded that there was no concern to the continued consumption of carrageenan and assigned it to the group "Acceptable Daily Intake - not specified". This classification is used when the JECFA has determined that a food additive does not represent a hazard to health. It also allows for the use of the additive at the level necessary to achieve the technical or functional effect in food, also referred to as the level of Good Manufacturing Practices (GMP). The complete report of this review was made publicly available in 2003 and therefore post dates the review by Dr. Tobacman. Carrageenan is considered a healthy food.
PT Bumina Inti Perkasa, as a Carrageenan processors have fueled the development of Kappaphycus alvarezii ("cottonii" to the trade) and Eucheuma denticulatum ("spinosum" to the trade) farming in Indonesia; total volume now exceeds 100,000 dried tons per month.
Croscarmellose Sodium is a Cross Linked polymer of Carboxymethyl Cellulose Sodium. Cross Linking makes it an insoluble, hydrophillis, highly obsorbent material, resulting in excellent swelling properties and its unique fibrous nature gives it excellent water wicking capabilities. Croscarmellose Sodium provides superior Drug dissolution and distegration.
Applications: Used as "Superior Disintegrate" in Capsule & Tablets.
Storage: Croscarmellose is stable though hygroscopic. It should be stored in well closed containers.
|1.||Description||White free flowing powder|
|2.||Identification||Test A.B.C. Passes|
|4.||Sodium Chloride & Sodium Glycollate||NMT 0.5%|
|5.||Water Soluble Material||NMT 10%|
|6.||pH 1% Sol||Between 5 and 7|
|7.||Heavy Metals||NMT 10 ppm.|
|8.||Degree of Substitution||Between 0.6 and 0.85|
|9.||Sulphated Ash %||Between 14 and 28%|
|10.||Settling Volume||Between 10 and 30 ml|
Hypromellose, short form of chemical name Hydroxypropyl methyl-cellulose (HPMC), is a semi synthetic, inert, viscoelastic polymer used as a lubricant, as well as an excipient (pharmacologically inactive substance used as a carrier for the active ingredients of a medication) and controlled-delivery component in oral medications found in variety of commercial products.
The very high viscosity of hypromellose makes it ideally suited to use in ocular preparations which are designed to address dry eye. Some artificial tears contain hypromellose, and the polymer is also used in some types of eye surgeries to keep the eye lubricated. As a lubricant, it can soothe the eye in case of irritation and also create a protective barrier to protect the eye from additional irritation.
This polymer is considered to be non-toxic, although it can be flammable in some settings, and is produced by many companies, some of which specialize in production for very specific applications. Products with hypromellose can be found over the counter in some regions, and are also available by prescription.
For a complete description visit here.
Capsugel launches new vegetarian capsules with improved stability.
Hard capsule manufacturer leader Capsugel has introduced a new vegetarian capsule with slower opening after swallowing, making it ideal for ingredients with bad taste like valerian root or garlic.
THE EXCIPIENT OF CHOICE
Microcrystalline Cellulose is hardly a new product. As a naturally occurring substance, it has proven to be stable, safe and physiologically inert.
Microcrystalline Cellulose revolutionized tablet making because of its unique compressibility and carrying capacity. It exhibits excellent properties as an excipient for solid dosage forms. It compacts well under minimum compression pressures, has high binding capability, and creates tablets that are extremely hard, stable, yet disintegrate rapidly. Other advantages include low friability, inherent lubricity, and the highest dilution potential of all binders. These properties make Microcrystalline Cellulose particularly valuable as a filler and binder for formulations prepared by direct compression, though it also is used in wet or dry granulation and for spheronisation/pelletisation.
WHAT IS MICROCRYSTALLINE CELLULOSE?
As the name implies, Microcrystalline Cellulose is basically cellulose and is derived from high quality wood pulp. While cellulose is the most abundant organic material, Microcrystalline Cellulose can only be derived from a special grade of alpha cellulose.
In many ways, Cellulose makes the ideal excipient. A naturally occurring polymer, it is comprised of glucose units connected by a 1-4 beta glycosidic bond. These linear cellulose chains are bundled together as microfibril spiralled together in the walls of plant cell. Each microfibril exhibits a high degree of three-dimensional internal bonding resulting in a crystalline structure that is insoluble in water and resistant to reagents. There are, however, relatively weak segments of the microfibril with weaker internal bonding. These are called amorphous regions but are more accurately called dislocations since microfibril containing single-phase structure. The crystalline region is isolated to produce Microcrystalline Cellulose.
NB's SANCEL CONSISTENTLY RELIABLE MICROCRYSTALLINE CELLULOSE
Processing of the cellulose microfibrils begins with shredding the sheets of high purity alpha grade pulp. The shredded pulp is immersed in hot bath of mineral acid that dissolves the amorphous regions of the microfibrils while leaving the microcrystalline segments intact. The object is to break down the long polymer chains. Hydrolysis is carried to the point where a leveling off degree of polymerization (LODP) is achieved. Consistency in LODP is checked routinely by quality control personnel.
Following hydrolysis, chemicals and impurities are removed through a water-washing step. This is followed by Spray drying. The slurry is sprayed through hot air jets to evaporate the water. This process produces particles of the desired size and moisture content.
While the process of producing Microcrystalline Cellulose appears to be relatively straight, the product quality is directly tied to various parametesr of the process in terms of time, temperature, pressure and purity of materials and the manufacturing environment.
THE SANCEL ADVANTAGE FACILITATION PHARMACEUTICAL MANUFACTURING SUCCESS
Presently, three types of Sancel is produced: Sancel 101, Sancel 102 & Sancel 112. Each corresponds to 50 micron, 90 micron and low moisture, respectively. SANCEL is purified partially depolymerized ALPHA CELLULOSE. It is White, Odorless and Tasteless, and free from organic and inorganic contaminations. It is insoluble in Water, Dilute Acids, and in mostly all organic solvents. Practically insoluble in Sodium Hydroxide solution: SANCEL, which has now become a synonymous name in pharmaceutical industries, is a must for quality as well as quantity products. The different grades are produced during final stages of the Sancel manufacturing process by altering the spray drying conditions.
Rapid drying produces aggregates of microcrystals with many dislocations and slip planes that can fracture and realign during tableting. This deformation is primarily plastic, so bonds formed under pressure remain formed after pressure is released, making for a strong, dense tablet with no capping. Microcrystalline Cellulose also is highly absorptive due to the capillary action of its surface porosity, making it possible to act as a carrier for liquids and yet retain free flowing and compression properties. Its porosity promotes easy wetting and rapid drying of wet granulation and exhibits good volumetric flow characteristic with low lubricant demand.
|Microcrystalline Cellulose Sancel-102|
|Parameters||IP||USP26 - NF21|
|Appearance||Fine or granular, white or almost white powder, free flowing||Fine or granular, white or almost white powder, free flowing|
|B + C||Comply||Not Applicable|
|B Degree of Polymerization||Not Applicable||< 350|
|pH||5 - 7.5||5 - 7|
|Starch and Dextrins||Absent||Not Applicable|
|Organic Impurities||Comply||Not Applicable|
|Organic Volatile Impurities||Not Applicable||Comply|
|Water Soluble Substances, %NMT||0.2||0.24|
|Ether Soluble Substances, % NMT||Not Applicable||0.05|
|Arsenic, PPM, NMT||2||Not Applicable|
|Heavy Metal, PPM, NMT||10||10|
|Residue on Ignition, % NMT||0.2||0.5|
|Loss on Drying, % NMT||6||6|
|Assay, %||97 - 102||Not Applicable|
|Conductivity, µS / cm,not exceed than water by||Not Applicable||75|
|Total Aerobic Microbial Count, CFU/g, NMT||1000||1000|
|Total Yeast and Mold Count, CFU/g, NMT||100||100|
|Pseudomonas aeruginosa, per 10 g||Absent||Absent|
|Escherichia coli, per 10 g||Absent||Absent|
|Staphylococcus aureus, per 10 g||Absent||Absent|
|Salmonella sp. per 10 g||Absent||Absent|
|Screen Analysis % Retention|
|60 Mesh, NMT||8|
|200 Mesh, NLT||45|
|Bulk Density, g/cc||0.28 - 0.33|
Silica (SiO2) is used as a food additive and as a food antioxidant. In pharmaceutical and nutraceutical production it is used as an anti-caking agent. It is approved internationally and by the FDA and Health Canada. It is an odorless, tasteless white powder with no biological activity.
Regardless of contacting, inhaling or ingesting, it is not be harmful to the human body. It is mainly applied to all kinds of powdery food to improve its flow performance; it prevents dry powder from caking.
For a complete description of Silicon Dioxide visit here.
Stearic acid (first syllable pronounced either steer or stair) is the saturated fatty acid with an 18 carbon chain and has the IUPAC name octadecanoic acid. It is a waxy solid, and its chemical formula is C18H36O2, or CH3(CH2)16COOH. Its name comes from the Greek word στέαρ ("stéar"; genitive: "stéatos"), which means tallow. The salts and esters of stearic acid are called stearates.
An isotope labeling study in humans concluded that the fraction of dietary Stearic Acidoxidatively desaturated to oleic acid was 2.4 times higher than the fraction of palmitic acid analogously converted to palmitoleic acid. Also, Stearic Acid was less likely to be incorporated into cholesterol esters. These findings may indicate that Stearic Acid is less unhealthy than other saturated fatty acids.
For a complete description visit here.