Ceftibuten as a Safe and Effective Treatment for Many Bacterial Infections

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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Soon To Be Generic Zolmitriptan Is An Effective Treatment For Patients Suffering From Migraines

April 26th, 2012

As an efficacious treatment for patients suffering from migraines, with or without auras, zolmitriptan is also known as Zomig, which is marketed by AstraZeneca. Zolmitriptan is a TEVA API, CAS number 139264-17-8. As exclusive Teva API distributors, LGM Pharma proudly offers zolmitriptan , as well as many other TAPI (Teva Active Pharmaceutical Ingredients) compounding products. On November 14th, 2012 Zomig will be off-patent, opening the door for generic versions of this formidable product.

Offered in both oral and orally disintegrating tablets, in 2.5 or 5 milligram tablets, zolmitriptan has been proven in numerous studies to be extremely effective. As migraines are headaches thought to result from the dilation of the blood vessels in the brain,  zolmitriptan causes the constriction of these blood vessels, thus relieving the pain of a migraine headache. Zolmitriptan is effectual in relieving migraine headaches, however, it does not prevent headaches prophylactically. Side effects of zolmitriptan include dizziness, drowsiness, dry mouth and nausea. In a class of medications called selective serotonin (5-HT) receptor agonists, zolmitriptan should be monitored when taken by patients who take selective serotonin reuptake inhibitors or monoamine oxidase inhibitors.

Encouraging research released from the ZODIAC study group showed zolmitriptan to be highly effective for patients who experience disabling migraine pain. This study, completed by Dr Jack Klapper from Colorado Neurology and Headache Center, and published in Cephalalgia, tested the efficacy of 2.5 milligrams of zolmitriptan in treating migraines. The objective of this study was to treat patients while their pain is mild, as the particular group of patients in the study typically experience migraine attacks that are initially mild, but progress to moderate or severe. This study was randomized and placebo-controlled, and involved 280 adult patients. Zolmitriptan, administered at a  2.5 milligram dose proved to offer a  significantly higher pain-free rate at the two hour mark, past the initial mild migraine pain patients experienced. In addition to these positive findings, those patients treated within the first 15 minutes of their migraine pain experienced the greatest medication benefit,  leading researchers to conclude that clinical benefits appear to be more pronounced when treating early onset migraines in patients.

 

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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Efficacious and Safe, Darunavir Ethanolate continues to Prove it’s Viability in the Protease Inhibitor Class of Drugs for HIV Treatment

April 23rd, 2012

HIVDarunavir Ethanolate, CAS number 635728-49-3, is also known by it’s brand name Prezista, and is used to treat HIV infection. In the class of protease inhibitors, darunavir ethanolate was approved by the FDA in June of 2006. What makes darunavir ethanolate unique is it’s ability to combat drug resistant strains of HIV in affected patients, as well as being efficacious when combined with other antiretroviral agents, such as ritonavir. Treatment with ritonavir is always recommended when taking darunavir ethanolate. While darunavir ethanolate does not cure HIV infection or AIDS, it  reduces the amount of the “viral load” or HIV in the blood, and increases  the CD4 (T) cell count. As HIV infection is known to destroy CD4 (T) cells, which in turn are crucial to the immune system, the ability of darunavir ethanolate to increase the CD4 (T) cell count is formidable in the treatment of AIDS. The risk of death and additional infections for patients with HIV infection is lessened with the treatment of darunavir ethanolate, thus providing a better quality of life for these patients.

hiv-mapThe brand of darunavir ethanolate, which is Prezista, is marketed by Janssen, and trademarked by Tibotec, Incorporated. Prezista is commonly taken alongside Norvir (ritonavir), once daily, at  the same time each day. Prezista is an integral part of the AIDS/HIV treatment combination. Darunavir ethanolate is offered as Prezista in tablet form in doses of 75, 150, 300, 400 and 600 milligrams. Patients are typically instructed to take darunavir ethanolate with food, and swallow as a whole tablet with either a full glass of milk or water. Prezista is prescribed to both adult and adolescent patients, ages six and older. Patients allergic to ritonavir should not take darunavir ethanolate or Prezista. Adverse effects of darunavir ethanolate are usually hyperglycemia, changes in the distribution of body fat, diarrhea, nausea, rash, headache, vomiting and rarely, life threatening liver problems.

In October of 2011 the FDA approved a label change for Prezista, adding data from a 192-week study deemed ARTEMIS. This study evaluated the efficacy and safety of both Prezista and ritonavir versus lopinavir and other antiretrovirals in patients with treatment-naive HIV-1. Postitive results were indicated, showing that 70% of the patients in the Prezista combination arm reached an undetectable viral load of less than 50 copies/m. versus only 61% of patients in the lopinavir combination arm. The tolerability and safety of Prezista in this study was apparent, with no serious side effects noted. As one of the most prescribed antiretroviral agents in the protease inhibitor class, this study confirms the success of darunavir ethanolate as a treatment for patients with HIV/AIDS. LGM Pharma provides darunavir ethanolate for research and development, and assists clients throughout the entire 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.

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Loteprednol Etabonate Safe for Children and Adults with Inflammatory Eye Conditions

April 19th, 2012

loteprednol etabonateLoteprednol Etabonate, also known as Lotemax, is an anti-inflammatory corticosteroid eye solution. As a prescription eye drop, loteprednol etabonate, CAS number 82034-46-6, is used to treat a variety of inflammatory eye conditions. These conditions typically affect the anterior chamber of the eye and include allergic conjunctivitis, superficial punctate keratitis, acne rosacea, Iritis, herpes zoster keratitis, cyclitis and certain types of infectious conjunctivitis. A typical dose for many of the aforementioned conditions is one to two drops in the affected eye(s), administered up to four times daily. Common side effects include vision disturbances, such as blurriness, dry eye, itching, swelling of the conjunctiva, excess tear production and light sensitivity. Systemic adverse effects such as headache and rhinitis have also been noted. The first patent for Lotemax expired as recently as March 2012. LGM Pharma provides API loteprednol etabonate for R&D purposes, and provides complete support to clients throughout the research and development process.

As an ester corticosteoid, loteprednol etabonate has shown a well documented safety profile through over a decade of studies. In addition to it’s efficacy in decreasing the production of inflammatory precurser proteins, loteprednol etabonate offers increased lipiphilicity, which allows a greater cell penetration. While loteprednol etabonate is structurally similar to other corticosteroid solutions, it is unique in that the number 20 position ketone group is absent in the structure, making it a highly lipid soluble treatment. In a trial studying the safety and effectiveness of loteprednol etabonate 0.5% versus prednisolone acetate 1.0% ophthalmic suspension, loteprednol was found to have a favorable profile in regard to intraocular pressure increases. This conclusion was published in the American Journal of Opthalmology, which revealed that the treatment of these patients with acute anterior uveitis saw less of an increase in intraocular pressure after receiving loteprednol etabonate. In opposition, patients who received prednisone acetate displayed a greater incidence of intraocular pressure increases.

Currently being explored for it’s use in treating seasonal allergies with allergic conjunctivitis, loteprednol etabonate is being marketed as such an eye drop by Bausch and Lomb, known as Alrex. The April 1, 2012 issue of Paediatric Drugs, published online, revealed results from a trial which measured both the tolerability and safety of loteprednol etabonate 0.5% and tobramycin 0.3%. These ophthalmic suspensions were tested in pediatric subjects, ages 0-6, in randomized and parallel group studies. Adverse events in the group of children who received loteprednol etabonate were deemed low, and the use of loteprednol was determined to be safe for children in short term dosing for conditions such as blepharoconjunctivitis.

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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Valsartan Found Safe for Use in Adults and Children with Hypertension

April 17th, 2012

ValsartanValsartan, CAS number 137862-53-4, is used as a treatment for high blood pressure, as well as congestive heart failure. As part of a class of medications called angiotensin II receptor antagonists, valsartan impedes the action of natural substances in the body that cause a tightening of blood vessels, thus allowing a smoother blood flow to the heart. Also known as Diovan, manufactured by Novartis in the United States, valsartan can be essential in the health of cardiac patients, especially after a patient experiences a heart attack. LGM Pharma is an exclusive provider of the Teva API Valsartan for compounding, research and development, as well as client support throughout the R&D process.

Available as a tablet in 40, 80, 160 and 320 milligram doses, valsartan can also be found in some markets as a hard gelatin capsule, containing either 40, 80 or 160 milligrams per dose. Typical doses range from 40 to 320 milligrams daily. Typical side effects include dizziness, headache, cough, nausea, exhaustion, joint pain, blurry vision, rash and diarrhea.

The patent protection for Diovan expires in 2012, making way for generic possibilities for this leading blood pressure drug. With the increase in childhood obesity, as well as hypertension in children rising, valsartan was recently tested in children ages 6-16. The results, published in The Journal of Clinical Hypertension on March 18, 2011 indicated a favorable response from the trial. There were 261 randomized children participating, and they received  a low (10/20 mg), medium(40/80 mg), or high dose (80/160 mg) of valsartan for two weeks total. Patients were randomized to a 2-week placebo-controlled withdrawal phase at the conclusion of two weeks. Both systolic blood pressure (SSBP) and sitting diastolic blood pressure (SDBP) were found to be lowered in the valsartan versus the placebo controlled group. In addition, the safety and efficacy of valsartan was impressive, with headache being the most adverse effect noted among adolescent patients. Researchers deemed valsartan to be safe and well tolerated, which is encouraging for further studies in treating hypertension in children.

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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