Carbapenems API’s for Antibiotic Resistance

A new publication is out called “May 19, 2016 – Tackling Drug-Resistant Infections Globally: final report and recommendations” and it highlights the antibiotic-resistant infections which are being seen for the 1st time in the U.S.

The review says “superbugs” could kill 10 million people each year and cost the world $100 trillion in lost economic output by 2050.

For the first time, a 49-year-old woman in Pennsylvania was infected with an E. coli which carried a gene for resistance against the drug colistin. She was successfully treated with an antibiotic. But, the Centers for Disease Control and Prevention, says “Antibiotic resistance is exploding in numbers as well as severity and the trends are alarming”. Read Article

Amoxicillin Effective When Timed Optimally Before Surgery

Prophylactic Antibiotics Effective When Timed Optimally Before Surgery

Antibiotics, such as Amoxicillin, are extremely effectual when used appropriately prior to surgical procedures. The expiration of the potent antimicrobial drug Moxatag, also known as Amoxicillin, on October 13, 2020, paves the way for additional development of this generic powerhouse. Study results recently released in Infection Control and Hospital Epidemiology reveal that timing is crucial for the proper use of prophylactic antibiotic treatment. Patients who receive antibiotic prophylaxis approximately two hours before a surgical procedure have a significantly reduced risk of surgical site infections. This data, released by the Rambam Medical Center in Israel on January 15, 2014 indicates that post-surgical patients can absolutely benefit from antibiotic prophylaxis if timed perfectly. Patients who receive antibiotic doses either before the optimal two hour timeframe, or once incisions are made have proven to have notably diminished benefits for infection control.

The aforementioned ten year study in Israel involved 2,537 patients who were in need of preoperative antibiotic prophylaxis, specifically prior to cardiac surgery. Patients involved were given antibiotics at different times, including three hours before surgery, two hours prior to their procedure, one hour before surgery and after surgery was concluded. Data gleaned from this large and randomized study revealed that surgical site infections were least common among the patients who were given antibiotics approximately two hours prior to their surgery. Exactly 8.3 percent of the patient group that received preoperative antibiotic treatment exactly two hours before surgery developed a surgical site infection. This small number of patients is compared with 13.9 percent of patients who developed a surgical site infection, which included patients dosed with prophylactic antibiotics at different times, and not during two hour window prior to surgery. Antibiotics, specifically Amoxicillin are regularly dispensed to patients with heart conditions, such as a heart murmur, prior to both simple and complicated surgical procedures.

LGM Pharma is an Amoxicillin API supplier/distributor for research and development purposes, as well as the sole supplier/distributor of Amoxicillin TEVA API for compounding in the U.S.. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk

Pyrazinamide is a Triple Threat to TB in HIV Patients

PA-824 + Moxifloxacin + PyrazinamideMidstage trial data of a Pyrazinamide cocktail to treat TB has offered encouraging news for patients with the HIV infection. Coined PaMZ, this drug trio includes Pyrazinamide and two antibacterial drugs, with results going into the Phase III trial looking promising. The antibacterial drugs are PA-824, which was initially developed by the Novartis and the potent antibiotic Moxifloxacin, also known as Bayer’s brand name Avelox. The 200 patient Phase II data touted exemplary results, with a 71 percent cure rate for patients as compared to standard single treatment therapy, which had a 38 percent cure rate. Additional good news regarding the Pyrazinamide cocktail is that this effectual treatment does not interfere with the antiviral medications taken by patients with the HIV infection. Statistically patients with the HIV virus are 30 times more likely to develop Tuberculosis {TB}, with this virulent disease killing one in every five patients worldwide. Several of the crucial antiviral treatments used to fight the HIV virus in patients are not compatible with many drugs to remedy TB, so the recent news regarding the Pyrazinamide trio was very encouraging.

Information from the PaMZ trial was recently revealed at the International AIDS Conference which was held in Melbourne. Study investigators are hopeful for the completion of the Phase III study, which is partially funded by the Bill & Melinda Gates Foundation. The Phase III trial is called STAND {Shortening Treatments by Advancing Novel Drugs}, and it will involve 1,500 patients in fifty sites and on four continents. Patients enrolled in this comprehensive study will receive the PaMZ triple trio and then be assessed for a speedy and reliable cure for TB. Patients will also be evaluated to ensure that there is no additional need for injections to treat Tuberculosis and be certain that patient’s HIV treatment regimen is not disrupted. Providing this efficacious drug treatment is approved patients, practitioners and the pharmaceutical companies will be overjoyed, as this triple treatment is 90 percent less expensive than existing treatments for drug-resistant forms of TB. Patients in underprivileged parts of the world where TB is both rampant and deadly will also benefit greatly from this Pyrazinamide cocktail. Upset stomach and fatigue are the most commonly reported side effects, and this Pyrazinamide cocktail is generally safe and well tolerated.

Pyrazinamide CAS 98-96-4As a first line drug in antituberculosis medications Pyrazinamide is a synthetic pyrazine analogue of nicotinamine which has powerful activity against mycobacterium tuberculosis. Roughly one third of the world’s population is infected with tuberculosis bacteria, but only a small number of those infected will become sick with TB.

LGM Pharma is a provider of Pyrazinamide, CAS # 98-96-4, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

Amikacin Glean Breakthrough Therapy Status

Amikacin CAS 37517-28-5 Breakthrough Therapy StatusThe end of June 2014 brought exciting news for Insmed’s liposomal Amikacin, known as the brand name Arikace, with a Breakthrough Status award from the FDA. Amikacin was specifically designated Breakthrough Status for treatment refractory nontuberculous mycobacterial lung disease in adult patients. As an inhaled antibiotic Amikacin is effectual for treating chronic nontuberculous mycobacterial lung disease, a condition which effects roughly 50,000 people in the United States. Amikacin {Arikace} is commencing Phase III development after positive results emerged from Phase II clinical trials.

Amikacin has proven to be a formidable opponent for fighting the Pseudomonas aeruginosa bacterium in patients with cystic fibrosis in Phase II trials. Patients with cystic fibrosis who received a once daily dose of Amikacin via an inhaled nebulizer system for 28 consecutive days demonstrated a superior clinical benefit as compared to a placebo. Additionally, patients tolerated Amikacin quite well and showed a sustained improvement in lung function as well as a reduction in the density of their Pseudomonas. Amikacin proved sustenance and efficacy in multiple cycles of treatments with additional patients too, in a successful long term open label study. These outstanding results have led study investigators to believe Amikacin will be equally effective in treating patients with chronic Pseudomonas lung infections.

Amikacin is currently administered to patients via Arikace, through an advanced pulmonary liposome technology that prolongs the release of Amikacin in the lungs. This inhaled formula is safe and tolerable as it minimizes systemic exposure. The ease of use and convenient dispensing makes this novel form of Amikacin an optimal choice for physicians treating patients with nontuberculous mycobacteria lung disease. Current treatment options for this chronic and debilitating lung disease involve multiple drugs for longer periods of time which have unfortunate adverse effects. Arikace {Amikacin} has been granted orphan drug status by the FDA and the European Medicines Agency for the treatment of Pseudomonas infections in patients who are suffering from cystic fibrosis. The FDA has also given Arikace orphan drug status to treat bronchiectasis in patients with either Pseudomonas or other susceptible pathogens.

LGM Pharma is a provider of API Amikacin CAS# 37517-28-5 and Amikacin Sulfate CAS# 37517-28-5, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

FDA Approves Dalbavancin for the Treatment of Acute Skin Infections

FDA Approved Dalbavancin CAS 171500-79-1 Acute Skin InfectionsExciting news was announced at the end of May 2014 from Durata Therapeutics with the FDA approval of Dalbavancin, their novel antibiotic treatment. Known as the brand name Dalvance, the FDA nod for Dalbavancin meets a current need for new, safe and efficacious antibiotics. Dalbavancin is officially approved to treat skin structure and bacterial skin infections in adults caused by gram-positive bacteria, which includes methicillin-resistant Staphylococcus aureus. As an effectual lipoglycopeptide, Dalbavancin works by interfering with cell wall synthesis, and is administered via an intravenous infusion. The IV infusion takes roughly thirty minutes to dispense, with the initial dose being 1000 milligrams. A follow up dose of 500 milligrams of Dalbavancin is administered one week after the first 1000 milligram dose.

Clinical trials showed Dalbavancin to be just as effective as Vancomycin for healing acute skin structure and bacterial skin infections. Adverse effects from Dalbavancin were uncommon, with the majority of complaints being diarrhea, nausea and headache. A rapid infusion of Dalbavancin should be avoided, however, due to a rare but possible risk of a reaction resembling red man syndrome. Dalbavancin will be available for clinicians as 500 milligram single use vials which need to be reconstituted with 25 milliliters of sterile water.

Studies of Dalbavancin have proven to be successful. One such study explored the treatment of acute bacterial skin and skin structure infections in older patients. These elderly patients suffered from cellulitis and had large lesions. The administration of Dalbavancin in these patients quickly elicited a substantial decrease in lesion size and abscesses proliferation. Additionally, patients with various subtypes of cellulitis showed similar positive outcomes after being administered with Dalbavancin. The option of outpatient dosing of Dalbavancin for patients offers a decrease in inpatient hospital stays, thus reducing overall risk of additional infections and also reducing the staggering cost of hospital care.

LGM Pharma is a provider of the API Dalbavancin, CAS# 171500-79-1 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.