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Hyaluronidase (ovine) | CAS No: 488712-31-8 | GMP-certified suppliers
A medication that enhances absorption and distribution of co‑administered injectable therapies and supports local rehydration across relevant clinical uses.
Therapeutic categories
Primary indications
- For increase of absorption and distribution of other injected drugs and for rehydration
Product Snapshot
- Injectable enzyme supplied as lyophilized powder or solution for subcutaneous use
- Used to facilitate absorption and dispersion of co-administered injectables and support rehydration procedures
- Approved in the US with both approved and investigational statuses noted for specific products
Clinical Overview
The pharmacologic action relies on catalytic hydrolysis of hyaluronic acid, an essential glycosaminoglycan contributing to the viscosity and structural integrity of connective tissue. By cleaving the glucosaminidic bond between C1 of the glucosamine residue and C4 of glucuronic acid, the enzyme transiently reduces the viscosity of the extracellular matrix. This effect temporarily increases tissue permeability, enabling broader distribution of injected drugs or dispersal of localized exudates and transudates.
Absorption, distribution, metabolism, and elimination data for ovine hyaluronidase are limited due to its protein nature and rapid inactivation in tissues. Activity duration is short, typically confined to the local site of administration, where endogenous inhibitors and proteolytic pathways reduce enzymatic function within hours. Systemic exposure is generally low when used as directed.
Safety considerations include the risk of hypersensitivity reactions, particularly in individuals with a history of allergic responses to animal-derived proteins. Localized adverse effects may include transient edema, irritation, or inflammation at injection sites. Intravitreal use requires adherence to aseptic technique and ophthalmic procedural standards to avoid infection or tissue injury.
For API sourcing, manufacturers should supply characterization data confirming enzymatic activity, purity profile, and absence of adventitious agents associated with ovine materials. Consistent activity units, validated inactivation of potential contaminants, and compliance with regional regulatory expectations are essential for formulation development and quality assurance.
Identification & chemistry
| Generic name | Hyaluronidase (ovine) |
|---|---|
| Molecule type | Biotech |
| CAS | 488712-31-8 |
| UNII | 64R4OHP8T0 |
| DrugBank ID | DB00070 |
Pharmacology
| Summary | Hyaluronidase enzymatically hydrolyzes hyaluronic acid in the extracellular matrix, reducing its viscosity and transiently increasing tissue permeability. By altering hyaluronan structure and influencing related pathways such as TGF‑β1 activity, it enhances the spread and absorption of co‑administered injectable agents. The primary therapeutic intent is to facilitate distribution of injected drugs and fluids. |
|---|---|
| Mechanism of action | Hyaluronidase is a spreading or diffusing substance. It increase the permeability of connective tissue through the hydrolysis of hyaluronic acid. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C1 of the glucosamine moiety and C4 of glucuronic acid. This temporarily decreases the viscosity of the cellular cement and increases diffusion of injected fluids or of localized transudates or exudates, thus facilitating their absorption. |
| Pharmacodynamics | Hyaluronidase hydrolyzes hyaluronic acid and increase diffusion of injected drugs, thus facilitating their absorption. Hyaluronidase is used for enhancing absorption and distribution of other injected drugs. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Hyaluronan | Humans | other |
| Transforming growth factor beta-1 | Humans | inhibitor |
Formulation & handling
- Hyaluronidase (ovine) is a recombinant/biologic enzyme supplied as both a liquid solution and a lyophilized powder requiring reconstitution for subcutaneous administration.
- Formulations must preserve enzymatic activity; avoid conditions that promote protein denaturation or adsorption to container surfaces.
- Stability is sensitive to temperature and pH variations, so cold‑chain handling and use of compatible diluents are key for maintaining activity.
Regulatory status
| Lifecycle | Patent protections in the US are reaching the end of their term, indicating that the API is moving into a later lifecycle phase. As patents expire, the US market is expected to shift toward greater generic participation and a more mature competitive landscape. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Hyaluronidase (ovine) is supplied by several US‑based manufacturers that serve as originators and contract producers, with multiple packagers supporting downstream distribution. Branded products such as Vitrase appear to be limited to the US market rather than having broad EU or global presence. Patent protection on these legacy formulations has long expired, indicating existing or ongoing generic and multi‑source competition. |
|---|
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Hyaluronidase is a type of Enzyme Replacements/modifiers
Enzyme replacements/modifiers are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) utilized in the treatment of various enzyme-related disorders. Enzymes play a vital role in the normal functioning of the body by catalyzing specific biochemical reactions. However, in certain medical conditions, the body may lack or produce dysfunctional enzymes, leading to serious health complications.
Enzyme replacement therapy (ERT) involves administering exogenous enzymes to compensate for the enzyme deficiency in patients. These enzymes are typically derived from natural sources or produced using recombinant DNA technology. By introducing these enzymes into the body, they can effectively substitute the missing or defective enzymes, thereby restoring normal metabolic processes.
On the other hand, enzyme modifiers are API substances that regulate the activity of specific enzymes within the body. These modifiers can either enhance or inhibit the enzyme's function, depending on the therapeutic objective. By modulating enzyme activity, these APIs can restore the balance of enzymatic reactions, leading to improved physiological outcomes.
Enzyme replacements/modifiers have shown remarkable success in treating various genetic disorders, such as Gaucher disease, Fabry disease, and lysosomal storage disorders. Additionally, they have demonstrated potential in managing enzyme deficiencies associated with rare diseases and certain types of cancer.
The development and production of enzyme replacements/modifiers involve rigorous research, formulation optimization, and adherence to stringent quality control measures. Pharmaceutical companies invest substantial resources in developing these APIs to ensure their safety, efficacy, and compliance with regulatory standards.
Overall, enzyme replacements/modifiers represent a vital therapeutic category in modern medicine, offering hope and improved quality of life for patients with enzyme-related disorders.
Hyaluronidase API manufacturers & distributors
Compare qualified Hyaluronidase API suppliers worldwide. We currently have 3 companies offering Hyaluronidase API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Bbi Enzymes | Producer | South Africa | South Africa | CEP, CoA | 4 products |
| Bioindustria | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 12 products |
| Kraeber & Co GmbH | Producer | Germany | Germany | CoA, GDP, ISO9001, MSDS | 12 products |
When sending a request, specify which Hyaluronidase API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Hyaluronidase API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Hyaluronidase API
Sourcing
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Technical
What is Hyaluronidase (ovine) (CAS 488712-31-8) used for?
Which therapeutic class does Hyaluronidase (ovine) fall into?
What conditions is Hyaluronidase (ovine) mainly prescribed for?
How does Hyaluronidase (ovine) work?
What should someone know about the safety or toxicity profile of Hyaluronidase (ovine)?
What are important formulation and handling considerations for Hyaluronidase (ovine) as an API?
Is Hyaluronidase (ovine) a biotech?
Are there special stability concerns for oral Hyaluronidase (ovine)?
Regulatory
Where is Hyaluronidase (ovine) approved or in use globally?
What’s the regulatory and patent landscape for Hyaluronidase (ovine) right now?
Pharmaoffer
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