API LYSOZYME hydrochloride is our highest-purity, pharmaceutical-grade lysozyme, produced from hen egg-white following stringent cGMP (current Good Manufacturing Practice) guidelines. As a globally recognized active pharmaceutical ingredient (API), our lysozyme is widely used across pharmaceutical, health, and wellness industries.
LYSOZYME is a key component of the natural immune defense system, exerting antibacterial, antifungal, antiviral, and anti-inflammatory effects. These broad-spectrum activities make it highly effective in pharmaceutical, dermatological, and oral care applications.
Taking inspiration from nature, the broad spectrum activities of API LYSOZYME are exploited in product formulations targeting colds, infections, and inflammatory conditions. Pharmaceutical applications of API LYSOZYME range from oral, oromucosal and dental to nasal, and ocular uses.
Lysozyme has demonstrated to be effective against:
- Herpes simplex virus type 1: An in-vitro trial has demonstrated that the cytopathogenic activity of the virus was marked inhibited by heat treated lysozyme and other modified lysozymes (guanidyl-lysozyme, lysozyme methyl ester and guauidyl-lysozyme methyl ester). The comparison with other antiherpetic drugs has shown that the antiherpes-cytopathic effect (CPE) activity of the heat-treated lysozyme (and the other modified lysozymes) is equal to or higher than that of compounds acknowledged to have a good antiherpetic activity.[14]
- Herpes zoster A human clinical study on 24 patients affected by Herpes zoster (different cutaneous areas) have been treated with 1g/day Lyozyme oral route and other 10 patients (control) with high doses of Vit B. Regarding the skin lesions, 88% of patients treated with Lysozyme gave favorable results while the pains were overcome in 71% of cases. In the control group only 30% of cases gave favorable results which were a lesser degree in comparison with the treated group. [15]
Lysozyme Against Herpes Zoster (Shingles)
Herpes Zoster, or shingles, is a painful viral infection caused by the Varicella-Zoster Virus (VZV). The condition leads to nerve pain, skin lesions, and inflammation, often resulting in long-term complications like postherpetic neuralgia (PHN).
- API LYSOZYME hydrochloride is a natural antiviral agent that supports Herpes Zoster treatment by:
- Inhibiting viral replication – Reduces the spread of Varicella-Zoster virus (VZV), limiting the severity of shingles outbreaks.
- Reducing inflammation – Its anti-inflammatory properties help alleviate nerve pain, swelling, and discomfort associated with shingles.
- Accelerating skin healing – API LYSOZYME promotes tissue regeneration, minimizing blistering, scarring, and secondary infections.
- Boosting the immune response – By enhancing natural immunity, API LYSOZYME helps the body recover faster from Herpes Zoster and strengthens defenses against future outbreaks.
Applications:
Due to its properties and therapeutic benefits, API Lysozyme HCl can serve as an active ingredient in various formulations tailored to specific diseases and patient populations. The following is a non-exhaustive list of potential conditions :
- Managing oropharyngeal and throat infections/inflammation, stomatitis, gingivitis, canker sores, laryngitis, pharyngitis, sore throat, mouth/throat redness and swelling, tonsillitis, croup, bronchitis, pneumonia, thrush, xerostomia, sputum expectoration difficulties in respiratory diseases, glossitis;
- Managing tooth extractions, dental decay, periodontitis, gingivitis, minor oral wounds, gum inflammation, post-surgery bleeding, and alveolar pyorrhea symptoms;
- Herpes zoster, herpes simplex, local adjunct treatment for better healing of skin lesions as a result of herpes infections (Herpes zoster, Herpes simplex), herpetic keratitis, Virus hepatitis, supportive treatment of HIV-1 patient;
- Decongestant of nose mucous membranes, cold & flu, rhinitis, allergic rhinitis, bacterial rhinitis, chronic sinusitis, bleeding after rhinological surgery
- Prophylactic increase of immune defense, adjuvant therapy to antibiotics and chemotherapy;
- Ulcerous colitis, chronic enterocolitis, gut inflammation, gut infections, colitis, inflammatory bowel disease/syndrome, improving gut performance, intestinal ulcerative disease;
- Internal and external hemorrhoids;
- Eye infections, eye redness, dry eye;
- Supportive treatment during cancer therapy, chemotherapy and radiotherapy-Induced oral mucositis, radiation dermatitis.
- Urogenital infections, urogenital redness;
- Ear infections. Ear redness, otitis;
- Treatment of wounds and small injuries (fissures of nipples).
Several pharmaceutical forms can be developed using Lysozyme as single or combined active principle, few of them are listed below, many others can be developed:
- Tablet/capsule/compressed lozenge/chewable tablet/coated tablet/effervescent tablet or granules/gastro-resistant tablets/orodispersible films/orodispersible tablet/powder for solution/effervescent powder.
- Mouthwash/powder for oral solution.
- Cutaneous gel/cream/patch/spray/paste/foam/shampoo.
- Gargle/nasal wash/nose drops/spray/gel.
- Eye solution/gel/ointment.
- Oral treatments – Capsules or tablets to enhance immune function against Herpes Zoster.
- Oromucosal and dental applications – Supporting oral and throat infections linked to viral activity.
- Topical formulations – Lysozyme-based creams or ointments to reduce pain, redness, and itching from shingles lesions.
- Nasal and ocular solutions – For antiviral and anti-inflammatory relief in mucosal applications.
Quality
At Bioseutica®, we are committed to delivering the highest quality API LYSOZYME hydrochloride, produced under strict cGMP compliance:
- 100% solvent-free manufacturing process – No solvents are used at any stage of production.
- Regulatory compliance – API LYSOZYME hydrochloride is supported by an Active Substance Master File (ASMF) / Drug Master File (DMF) in CTD (Common Technical Document) format, ensuring global ICH regulatory approval.
- Strict quality control – Our Dutch Health Authority-approved manufacturing site undergoes regular inspections to maintain full cGMP compliance.
- Stability data supporting a shelf-life up to 60 months, with no special storage conditions.
- SOLVENT-FREE: No use of organic solvent (only water!)
- Non-GMO / non-microbial origin
- Nitrosamine-free
- Full compliance with “ICH Q3D: Guideline for Elemental Impurities”: no additional specifications required.
- Absence of POTENTIAL ADVENTITIOUS AGENTS confirmed by specific viral clearance studies on the manufacturing process!
Regulatory
Our Regulatory Affairs team provides comprehensive support to pharmaceutical clients, ensuring faster medicinal product approval and reduced time to market. We offer full technical and applications support, helping businesses integrate API LYSOZYME hydrochloride into pharmaceutical solutions.
- Advanced manufacturing process (cGMP).
- Selling Unit: Kilograms (Kg)
At Bioseutica® we offer a full range of services, encompassing both technical and applications support. Contact us today to discuss your specific requirements using the form below
References
- Ferraboschi, P.; Ciceri, S.; Grisenti, P. Applications of Lysozyme, an Innate Immune Defense Factor, as an Alternative Antibiotic | Publisher Site
- Takada K et al.: Detoxification of lipopolysaccharide (LPS) by egg white lysozyme | Publisher Site
- Tagashira A. et al.: Lysozyme from hen egg white ameliorates lipopolysaccharide-induced systemic inflammation in mice | Publisher Site
- Derde M et al.: Hen Egg White Lysozyme Permeabilizes Escherichia coli Outer and Inner Membranes | Publisher Site
- Derde M et al.: Native lysozyme and dry-heated lysozyme interactions with membrane lipid monolayers: Lateral reorganization of LPS monolayer, model of the Escherichia coli outer membrane | Publisher Site
- Ferrari R.: Antiviral activity of Lysozyme Nature 1959 | Publisher Site
- Lee-Huang S et al.: Lysozyme and RNases as anti-HIV components in beta-core preparations of human chorionic gonadotropin | Publisher Site
- Malaczewska et al.: Antiviral effects of nisin, lysozyme, lactoferrin and their mixtures against bovine viral diarrhoea virus | Publisher Site
- Fukai et al.: New possibilities for egg white lysozyme: heat-denatured lysozyme partially inactivates select foot-and-mouth virus strains | Publisher Site
- Sebaa S. et al.: Dose-dependent effect of lysozyme upon Candida albicans biofilm | Publisher Site
- Samaranayake Y et al.: Antifungal Effects of Lysozyme and Lactoferrin against Genetically Similar, Sequential Candida albicans Isolates from a Human Immunodeficiency Virus-Infected Southern Chinese Cohort | Publisher Site
- Dai, P.; Li, Q.: Lysozyme : Research progress in the application of lysozyme in food and medicine field - A review | Publisher Site
- Jiang L. et al.:Recent Insights Into the Prognostic and Therapeutic Applications of Lysozymes. Front. Pharmacol. 12:767642. 2021 | Publisher Site doi: 10.3389/fphar.2021.767642
- Cisani, G., Varaldo, P.E., Ingianni, A., Pompei R., Satta, G. (1984). Inhibition of herpes simplex virus-induced cytopathic effect by modified hen egg-white lysozymes. Current Microbiology; 10: 35-40.
- G.F. Strani “Il trattamento dello Zoster con lisozima ad alte dosi per os. Minerva dermatologica, Vol.43, n.6 – Pag. 288-295 (June 1968)
API Lysozyme embodies three main biological activities which are of significance to human health. These include antibacterial action, antiviral action and modulation of the immune response.
The antibacterial effects of Lysozyme are achieved through destabilization and degradation of the bacterial cell wall, while the antiviral activities have been attributed to interference with synctia formation and binding of viral nucleic acids. The antiinflammatory and immune potentiating properties of lysozyme have been well documented, however the mode of action is complex and has not yet been fully elucidated.
Bioseutica is the first company in the world to have a DRUG MASTER FILE for the use of API Lysozyme in pharmaceutical applications.
Oral Lysozyme acts directly in the oral cavity or gastrointestinal tract to impede the growth and colonization of pathogenic bacteria.
Oral Lysozyme also works indirectly through interactions with immune inductive sites of the gastrointestinal tract and systemic components of the immune system. The result is an immune modulating effect that is beneficial in a range of health afflictions where the immune system is in a depressed or imbalanced state.
Topical Lysozyme acts locally at the site of tissue damage to control microbial dissemination and inflammation. These activities combine to speed the reparative process of damaged skin.