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Trandolapril is Effectual and Profitable

Thursday, September 20th, 2012

TrandolaprilTrandolapril, CAS number 87679-37-6, is intended for patients with hypertension, or for anyone who has experienced heart failure post myocardial infarction. Particularly effective for those patients who have left-ventricular dysfunction after a heart attack, trandolapril is an angiotensin-converting enzyme, or ACE inhibitor. Marketed by Abbott as the brand name Mavik, the patent for this lifesaving medication is due to expire on April 28, 2015. Available in 1, 2 or 4 milligram tablets, trandolapril is typically taken as 2-4 milligrams once daily, if the patient is not taking additional diuretics. Side effects tend to be mild, and may include muscle pain, cough and dizziness.

Race matters in terms of dosing patients with trandolapril. Patients who are African American should start their dose at 2 milligrams daily, providing they are not taking a diuretic. Caucasian patients should begin their dose at 1 milligram daily, also as long as they do not take a diuretic. All patients, regardless of race should be titrated over time, receiving increased dosing based on one week intervals. The maximum safe dose is 8 milligrams, given in two divided doses.

Pharmaceutical success has been found with mavik, or trandolapril, as Abbott reported better than expected first quarter revenue and income on April 18, 2012. Profits were up 44% from $864 million dollars to $1.24 billion dollars. In the press release it was announced that this monumental gain was due in part to their cardiovascular line of products, including trandolapril (Mavik).

One of many successful clinical trials involved patients who were considered stable, 3 to 7 days after myocardial infarction and showed left ventricular dysfunction. This trial, deemed TRACE, or Trandolapril Cardiac Evaluation, involved a 27-center Danish study. The trial was a double-blind, placebo controlled, and parallel-group study. Participants with residual ischemia and heart failure were included. The group of patients who tolerated the initial dose of 1 milligram were then randomized to either a placebo or trandolapril, and followed for 24 months. The 876 patients who received trandolapril experienced an average 16% risk reduction in mortality. Of the patients who required a higher dose of trandolapril, 62% were eventually administered 4 milligrams, once daily. All patients who were given trandolapril also saw a 20% overall risk reduction for the progression of heart failure. LGM Pharma is a provider of the API trandolapril for research and development purposes. Total support is offered to clients for all R&D needs.

 

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.

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Posted in Anti-Hypertensive, Cardiovascular Agent, Drug Research & Development API, General API, Patent Expiration 2015, Respiratory Tract Agent, Therapeutic Classification | No Comments »

Shocking Diagnosis of Reality Star Creates a Whirlwind of Attention for Glatiramer Acetate

Friday, June 22nd, 2012

Jack OsbourneGlatiramer, CAS# 28704-27-0, and Glatiramer Acetate, CAS# 147245-92-9, are also known as Copaxone. In the spotlight recently, Copaxone’s patent is due to expire on May 24, 2014. The flurry of interest regarding Copaxone follows the devastating diagnosis of Multiple Sclerosis for beloved reality star Jack Osbourne. In mid June of 2012 reports surfaced about Jack’s new battle, which he was saddled with just three weeks after the birth of his daughter. Symptoms like a 60 percent sight loss in one eye and tingling in his extremities led this young man to seek medical attention. Typical symptoms of MS include inflammation in the brain and spinal cord, causing the loss of myelin or insulation around the nerves, as well as weakness, fatigue, vision loss, and numbness. The progression of MS is unknown and can vary with each patient, causing acute symptoms to be mild, moderate or severe. However, in the midst of the disturbing news there is hope. Glatiramer, or Copaxone, marketed by Teva, is a definite treatment option for Mr. Osbourne, according to reports at NBC.com. In addition to treatment with not only glatiramer acetate, patients like Jack have a variety of symptom easing medications, such as dexamethasone and prednisone for swelling and inflammation, and trazadone for depression and tremors.

Glatiramer Acetate is an immunomodulating drug, and is essentially an artificial protein that resembles a natural myelin protein. It is believed to be effectual by preventing the body’s immune system from attacking the myelin coating that protects nerve fibers in patients with MS. Given as an injection, subcutaneously once a day, glatiramer was formerly known as copolymer-1. Offered in a 20 milligram size, glatiramer may cause adverse effects such as diarrhea, headache, depression, nausea, vomiting, ear pain, joint pain and purple patches on the skin.

Glatiramer AcetateOn June 14, 2012 Teva reported that goals from a late stage clinical trial recently were revealed, and pointed to a favorable outcome for patients taking Copaxone. Patients who took the newer version of glatiramer acetate were reported to be 34 percent less likely to have a symptom relapse. This study lasted a year, and compared patients who took a placebo, versus patients given glatiramer. With the patent for Copaxone set to expire in less then a year, this information is uplifting and reassuring to researchers, prescribers and patients. LGM Pharma is a provider of the API glatiramer acetate and glatiramer, and offers complete support to clients throughout the R&D process. As the Sole Distributor of Teva for their extensive API portfolio, for the US pharmacy compounding market, LGM Pharma looks forward to providing clients with TEVA products, as well as other quality API products.

 

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.

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Posted in Drug Research & Development API, General API, Immunological Agent, Patent Expiration 2014, Therapeutic Classification | 1 Comment »

Established Carvedilol Poised to be a Leading Generic Beta-Blocker

Thursday, June 21st, 2012

model-heartCarvedilol, CAS# 72956-09-3, is known as the brand name Coreg, which is marketed by GlaxoSmithKline. The patent for Coreg will expire on June 7, 2015, making way for a generic market. As a beta-blocker used to treat hypertension and heart failure, carvedilol is also often prescribed to treat and prevent heart attack symptoms. Carvedilol is also an impressive treatment for patients who have survived a myocardial infarction, and experience a left ventricular dysfunction with an ejection fraction of less than 40 percent. In terms of treating patients with high blood pressure, carvedilol is a sound choice for the management of essential hypertension, and it can be utilized as monotherapy or in conjunction with other antihypertensive agents, such as thiazide-type diuretics.

Individualized dosing is recommended, however, the typical dose for patients with hypertension is the 6.25 milligram tablet, taken twice daily. Once the patient has displayed a tolerability to the lowest dose it is commonly increased to the 12.5 milligram tablet, taken twice daily. One to two weeks normally lapse in between dosage increases to lend enough time for the patient to show a safe, effective and tolerable reaction to this drug. Some patients are eventually dosed to a 25 milligram tablet, also taken twice a day. Patients are not advised to take any more then 50 milligrams daily. Side effects are usually not severe, and may include a decreased sex drive and impotence, insomnia, nervousness and anxiety.

CarvedilolEvaluated for safety in over 2,193 patients in U.S. clinical trials, as well as 2,976 patients in international trials, carvedilol has proven itself to be a strong and dynamic medication. One particular clinical trial, deemed CAPRICORN, compared carvedilol and a placebo for the treatment of patients who had experienced a recent myocardial infarction. This patient population had a documented left ventricular ejection fraction of less then 40 percent, and 47 percent of these patients also exhibited symptoms of heart failure. The CAPRICORN study was a double-blind study, which involved 1.959 patients. Results were outstanding in favor of the patients who received carvedilol, starting with 6.25 milligrams a day and titrated to 25 milligrams twice a day. The mortality risk was a 23 percent reduction in patients treated with carvedilol, and there was an admirable 40% reduction in fatal and non fatal future myocardial infarctions. The Vascular Health and Risk Management posted a report in June of 2012 which enumerated reasons for their support of carvedilol. Specifically they noted that as a noncardioselective third-generation beta-blocker, carvedilol was effective while still being free of negative hemodynamic and metabolic effects, which many traditional beta-bockers have. In addition, when compared with fellow beta-blockers, carvedilol was found to consistently maintain cardiac output and offer a sizable reduction in the risk of hypertension. Patients suffering from various metabolic syndromes or diabetes reported positively with treatment of carvedilol, and exhibited favorable effects which were demonstrated in their metabolic profiles. LGM Pharma is a proud provider of both the API and TEVA API carvedilol, and offers client support throughout the research and development 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.

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Posted in Anti-Hypertensive, Bulk Active Ingredient, Drug Research & Development API, General API, Patent Expiration 2015, Respiratory Tract Agent, Therapeutic Classification | No Comments »

Is Capecitabine the Next Generic Blockbuster of Chemotherapy Drugs?

Tuesday, June 19th, 2012

Capecitabine, 154361-50-9Regarded as a blockbuster drug used to treat both metastatic breast and colorectal cancer, Capecitabine is also known by the trade name Xeloda, which is marketed by Roche Pharamaceuticals. Capecitabine, CAS# 154361-50-9, is waiting in the wings to become a generic boon in the pharmaceutical industry, as the patent for Xeloda meets an expiration in December of 2013. The expiration of the ’949 patent on December 14, 2013 is projected to successfully lead to the roll out of additional patents for this formidable drug through 2015. As the the first oral chemotherapy drug approved in the United States for breast and colorectal cancer, as well as Dukes’ C Stage III colon cancer, capecitabine is an effective chemotherapeutic agent. Offered in 150 and 500 milligram tablets, capecitabine is efficacious as an antimetabolite, and  it works by stopping or slowing the growth of cancer cells. Typically prescribed twice daily, to be taken in the morning and in the evening, capecitabine is commonly taken for two weeks and  followed with a one week break. The dosage cycle may or may not be repeated, depending on patient specifications for treatment. It is best to take capecitabine with a full glass of water, and after a meal. Adverse effects include stomach pain, constipation, increased thirst, loss of appetite, exhaustion, weakness, hair loss, dizziness and skin rash.

Researchers concerned with the use of capecitabine as an adjunct alongside other chemotherapeutic agents are currently exploring these prospects. Thus far positive information has been gleaned by researchers who have studied capecitabine and temsirolimus, CAS# 162635-04-3. Georgetown University Medical Center  released initial results from Phase I trial which examined the use of both temsirolimus and capecitabine to treat patients with advanced malignancies. The phase 1 results were published May 16, 2012 and indicated promising evidence to continue to Phase 2 trials after the presentation of the results at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago in June 2012. In addition, researchers published study results in the American Journal of Clinical Oncology on May 22, 2012 indicated a positive response to the combination of thalidomide and capecitabine. This combination was successfully given to patients with advanced hepatocellular carcinoma, and indicated a positive pathological response rate for this patient population. Participants were dosed with 2000 milligrams of capecitabine for 14 days, every 3 weeks, as well as an oral dose of thalidomide ranging from 50 to 200 milligrams. The median survival rate for patients in this study was 5.1 months.

LGM also offers capecitabine as a TEVA API (TAPI) product for compounding purposes in the U.S., and strives to meet the total needs of clients throughout the research and development 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.

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Posted in Antineoplastic, Bulk Active Ingredient, Chemotherapeutic / Anti-Neoplastic, Compounding API, Drug Research & Development API, General API, Patent Expiration 2015, Therapeutic Classification | No Comments »

Ceftibuten as a Safe and Effective Treatment for Many Bacterial Infections

Friday, April 27th, 2012

Ceftibuten HydrateCeftibuten Hydrate, CAS number 118081-34-8, is a cephalosporin antibiotic. Used as a treatment for bacterial infections such as bronchitis and ear infections, ceftibuten can also be found by it’s brand name, Cedax. Cedax is manufactured by Pernix Therapeutics, who purchased the drug in March 2010 from Shionogi Pharma Inc. Ceftibuten is an effective third generation cephalosporin treatment for patients, and LGM Pharma is a provider of the API ceftibuten for research and development.

Offered as 200 and 400 milligram capsules, or as a suspension of 90 milligrams/ 5 milliliters, ceftibuten has proven it’s efficacy in treating a variety of bacterial infections. In addition to the aforementioned bronchitis and Otitis Media, ceftibuten is extremely successful for the treatment of tonsillitis, pharyngitis, cystitis, sinusitis and pneumonia. In clinical trials ceftibuten was shown to be safe, without incidence of permanent disabilities or loss of life. In one large trial 1,728 adult patients were given a 400 milligram capsule of Cedax once daily for ten days, and only 2% of participants opted to discontinue treatment before completion of the trial. This small percentage of trial participants opted out due to adverse side effects related to gastrointestinal issues, such as diarrhea and nausea. Side effects may occur with treatment of ceftibuten, such as nausea, upset stomach, vomiting and diarrhea.

Physicians who prescribe ceftibuten to patients need to inquire with patients if they have an allergy to cephalosporins, or may be taking anticoagulants, have kidney or liver disease. Ceftibuten should be taken with a full glass of water, with or without food. In addition, patients should let their provider know if they are taking vitamins or supplements, as this could interfere with the efficacy of ceftibuten. Medications that reduce stomach acid, like Tagmet, can also interfere with the effectiveness of this antibiotic.

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.

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Posted in Antibiotic, Drug Research & Development API, General API, Therapeutic Classification | No Comments »

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