Product List and Regulatory Information

Jungbunzlauer is one of the world’s leading producers of biodegradable ingredients of natural origin based on fermentation technology. With our four production sites in Germany, France, Austria and Canada we offer a broad range of products, which can be applied as excipients, intermediates or active pharmaceutical ingredients (API’s) in many pharmaceutical applications.

API’s are produced in the cGMP production site in Ladenburg, Germany which is registered with German authorities (§67 AMG) as an API manufacturer and has continuously been found to be compliant to ICH Q7A and US FDA’s cGMP requirements since 2001.

Upon request, we can provide a documentation & service package for the specific regulatory needs linked to Jungbunzlauer’s products, such as open DMF in CTD format, stability data, letter of access to existing DMF and further services concerning change control and yearly updates.



Citrics

Citric acid is a widely used ingredient well known for its pleasant sour taste, excellent solubility and effective pH regulation. Jungbunzlauer also offers various citrate salts that are derived from citric acid.

Citric Acid

The applications of citric acid and citrates in the pharmaceutical industry are manifold. In most pharmaceutical products citric acid is used as excipient, acting as acidulant, pH regulator and effervescent aid in applications like tablets, dry blends, emulsions and suspensions. For the application as API, Jungbunzlauer has developed a special citric acid grade which is documented with a Drug Master File (DMF). API functionalities comprise e.g. its use as blood anticoagulant, bowel cleaning agent and (in combination with alkaline salts) neutralizing excess stomach acid in situ.

Trisodium Citrate

Trisodium citrate, mostly used in its dihydrate form, offers excellent pH regulation and buffering when used as excipient. It is applied as blood anticoagulant as well as systemic alkalizer. Jungbunzlauer also offers trisodium citrate anhydrous. The anhydrous form of trisodium citrate provides very specific advantages for dry blends and tablets due to its ability to absorb excess humidity, thus adding storage stability to the end product. Other citrate salts are covered by Jungbunzlauer’s product group Special Salts.



Gluconates

Due to their high purity and compatability, Jungbunzlauer gluconates have a long history of use as high quality starting materials and excipients.

Sodium gluconate

Jungbunzlauer’s sodium gluconate is specified according to the United States Pharmacopeia (USP). The outstanding chelating power of sodium gluconate for iron also permits its use in iron deficiency treatments. Sodium gluconate can act as a pH regulator and buffering agent. It can also stabilize and inhibit the bitterness of minerals, and it can improve the taste of intense sweeteners in oral medications.*

Glucono-delta-Lactone

Jungbunzlauer’s glucono-delta-lactone (GdL) is specified according to USP. GdL is used as a starting material for the production of mineral gluconates (calcium gluconate, potassium gluconate, zinc gluconate etc.) as well as chlorhexidine gluconate and quinidine gluconate. Glucono-delta-lactone can also act as a controlled release agent as well as a mild tasting acidifier in effervescent systems.


*Remark: Sodium gluconate is also used as an API in electrolyte solutions. Due to regulatory constraints, Jungbunzlauer is not able to supply sodium gluconate as API to pharma customers (Pharma GMP status required).



Special Salts

Through neutralization of citric or gluconic acid, Jungbunzlauer offers a unique range of high purity organic sources of calcium, magnesium, potassium, sodium and zinc salts which are used as active ingredients or excipients in dietary supplements and pharmaceuticals. Our mineral salts show proven efficacy in clinical studies with regard to the prevention and treatment of diseases such as kidney stones, osteoporosis and constipation as well as causes of mineral deficiencies in general.

Monosodium Citrate

Monosodium citrate represents a partially neutralized, mild acid, which is mainly used as an excipient in effervescent tablets and dry blends. It can partially or fully replace buffer systems, e.g. citric acid and/or trisodium citrate in sensitive formulations due to its anhydrous form, low reactivity, good flowability and low hygroscopicity.

Tricalcium Citrate

Due to its superior bioavailability and high calcium content (21%), this product is the most prominent organic calcium salt used to prevent and treat osteoporosis. In contrast to other calcium salts, tricalcium citrate does not promote but rather inhibits the formation of kidney and urinary tract stones by providing beneficial citrate for renal excretion. Whereas coarse tricalcium citrate is recommended for tabletting, micronized product is preferred in dispersed and dry systems.

Trimagnesium Citrate

Being highly bioavailable, this active ingredient is recommended for effective treatment of magnesium deficiency, e.g. to prevent muscle cramps. At high dosage levels, trimagnesium citrate is applied as laxative. For usages as API an Active Substance Master File (ASMF) has been filed in September 2010. Whereas trimagnesium citrate nonahydrate displays lower hygroscopicity, the anhydrous is preferred in those applications where high magnesium content and/or solubility is required. As an excipient, the anhydrous form may be used as desiccant, e.g. in tablet vials.

Tripotassium Citrate

Jungbunzlauer is the worldwide leading supplier of tripotassium citrate with pharmaceutical quality and documentation, including a Drug Master File (DMF). Tripotassium citrate finds widespread usage in nutritional and pharmaceutical applications as a potassium source. As systemic alkalizer, it is well-known as an active ingredient aiding in dissolving kidney stones. Most recent research co-sponsored by Jungbunzlauer highlights the positive effect of tripotassium citrate also on bone mineral density and cardiovascular health.

Zinc Citrate

Main usages of zinc citrate are oral remedies to fight common colds as well as diarrhea. For topical applications, its anti-oxidant and anti-inflammatory properties are exploited for skin treatment and wound healing.

Calcium Lactate Gluconate

Due to its outstanding solubility and neutral taste, this highly bioavailable calcium salt is preferred for effervescent tablets, sachets and liquid dosage forms.

Potassium Gluconate

Like tripotassium citrate, potassium gluconate can serve as a potassium source against potassium deficiency or as a systemic alkalizer. Compared to other potassium salts, the anhydrous potassium gluconate shows only little hygroscopic behavior.



Specialties

Jungbunzlauer has developed a variety of citrate based derivatives, which provide specific functionalities in pharmaceutical applications.

CITROCOAT® N

CITROCOAT® N is based on citric acid as core material, with a layer of monosodium citrate as shell material. Compared to regular citric acid it is less hygroscopic and less reactive with other ingredients in solid dosage forms, e.g. dry blends, thus leads to more stable products with increased shelf life. However, when dissolved in water CITROCOAT® N has the same functionality as regular citric acid.

Citro DC

Citro DC is the direct compressible type of citric acid anhydrous. A thin layer of maltodextrin on the surface improves both processing speed for tablets and enhances tablet hardness.

CITROFOL® (Citric Acid Esters)

CITROFOL® is the branded range of esters which are used as preferred plasticisers in both aqueous and solvent based coating systems. They are typically added between 10 to 40% to provide the film strength and permeability required for the controlled release of the active ingredient. CITROFOL®’s plasticiser properties are also exploited in medical devices as non-phthalate alternative in polymer products, e.g. in PVC-tubes and also in adhesives for skin friendly and non-allergic bandages.



ERYLITE®

ERYLITE® is used as intermediate and especially as excipient. As a bulk sweetener, it brings a number of benefits into pharmaceutical products, i.e. zero calorie level, non cariogenicity and a zero glycemic index. On its own it is less sweet than sugar, but increases the sweetness of other sweeteners. As it can also reduce bitterness, it can improve the taste of pharmaceutical products.



Xanthan Gum

Xanthan gum is a polysaccharide with remarkable rheological behaviour. As an excellent thickening, stabilizing and suspending agent it is used in a large number of liquid pharmaceutical formulations. For syrups and dysphagia products (swallowing agents) xanthan gum provides viscosity for ease of swallowing. In dentifrice products it improves the cling to the surface of the teeth. Furthermore, xanthan gum is applied in many solid formulations. In lozenges it prolongs contact time of active ingredients and in tablets it controls drug release.

 
 

Source: Products + Regulatory
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