Lallemand Pharma offers to its network of pharmaceutical partners a drug, PMBL ® sublingual tablets and two ranges of medical devices, the nasal spray lines Healsea® bag on valve technology and Healsea® manual spray pump.
PMBL® sublingual tablets are made out of unique active substance of bacterial lysate obtained by mechanical lysis. PMBL® based drugs are indicated in the prevention of recurrent respiratory tract infections.
Healsea® nasal sprays all contain the active substance Symbiofilm®, an exopolymeric ingredient that slows down the turn over of pathogenic bacteria biofilm and prevents the attachment of respiratory viruses on nasal mucosa.
The indication of the different formulations range from treatment of nasal symptoms of acute respiratory tract infections up to treatment of nasal symptoms of Chronic Rhinosinusitis depending on the concentration in Symbiofilm®
Each tablet contains 50 mg of Lyophilised Bacterial Lysate, of which 7 mg correspond to: Staphylococcus aureus 6 billion, Streptococcus pyogenes 6 billion, Streptococcus oralis 6 billion, Klebsiella pneumoniae 6 billion, Klebsiella ozaenae 6 billion, Haemophilus influenzae 6 billion, Neisseria catarrhalis 6 billion, Streptococcus pneumoniae 6 billion (of which Type 1, 1 billion – Type 2, 1 billion – Type 3, 1 billion -Type 5, 1 billion – Type 8, 1 billion – Type 47, 1 billion) and 43 mg of Glycine as support of lyophilization.
LIST OF EXCIPIENTS
Colloidal hydrated silica, Cellulose microcrystalline, Calcium hydrogen phosphate dihydrate, Magnesium stearate, Ammonium glycyrrhizate, Essence of mint powder.
Pack of 1 blister of 10 tablets, pack of 3 blisters of 10 tablets
Bacterial lysates are mixtures of bacterial antigens derived either from single or multiple strains of inactivated pathogenic bacteria. The principle of bacterial lysates is to trigger immune surveillance and to up-regulate immune defences to prevent and help fight infections. Bacterial lysates are sometimes referred to as ‘oral vaccines’.
Based on the method used for cellular lysis, two distinct types of bacterial lysates are defined: chemical lysates obtained by the action of chemical alkaline substances (PCBL, for polyvalent chemical bacterial lysates) and mechanical lysates obtained by increased pressure (PMBL for polyvalent mechanical bacterial lysates).
PMBL is a mixture of antigens derived from 13 strains of inactivated pathogenic bacteria, which is the reason why it is called Polyvalent. The 13 strains used in PMBL are typically the most commonly occurring pathogens of the upper and lower respiratory tract.
Each bacterial strain is grown independently, harvested, inactivated and lysed using unique LALLEMAND’s mechanical lysis process in order to obtain the antigens.
This original process of mechanical lysis allows preserving the antigens structure, and especially the particulate antigens. It confers to PMBL a higher immunogenicity as compared to chemical bacterial lysates, which has been demonstrated both in vivo and in clinical trials.
PMBL tablets is distributed under different brandnames depending on the country of distribution (Ismigen®, Immubron®, Respibron®, PIR-05®, Pulmigen®…).
DUAL MODE OF ACTION
Thanks to its unique mode of action, PMBL is able to act both on innate (thanks to stimulation and maturation of dendritic cells, Natural Killer cells and Granulocytes…) and adaptive (thanks to specific stimulation of T and B lymphocytes and secretion of targeted antibodies) immunity. In fact PMBL is a two in one immunostimulating agent offering a broaden prophylaxis against respiratory infections.
1. Sampling of antigens contained in PMBLTM tablets at the level of oral mucosa by dendritic cells.
2. Maturation, activation and migration of the dendritic cells to the cervical lymph node and secondary
3. Presentation of the antigens by the dendritic cells to the T lymphocytes, and secretion of pro-inflammatory
cytokines by dendritic cells. Activated dendritic cells allow proliferation of polyclonal NK cells.
4. Differentiation and increase of T helper cells allowing switch of B lymphocytes to plasma cells.
5. Increase of early Memory B cells.
6. Production of specific polyclonal immunoglobulins (IgA, IgG and IgM) by plasma cells.
7. Circulation into the blood of the immune-competent cells (T helper, plasma cells, NK cells) and
8. Secretion of polyclonal secretory IgA at the level of upper and lower respiratory mucosa.
9. Phagocytosis of bacteria by granulocytes thanks to opsonizing immunoglobulins and destruction of
viral infected cells by NK cells.