Protein Therapeutics And The Marriage Of Drugs And Devices - Analyzing The Rapid Growth Of Biological Combination Products

In recent years, number of protein-based pharmaceuticals reaching marketplace has increased exponentially. The clinical application of these drugs is limited by a lack of desirable attributes for adequate absorption or distribution. It therefore becomes critical to formulate these drugs into safe, stable and efficacious delivery systems. Because these drugs face formidable enzymatic and penetration barriers when administered orally, peptide and protein drugs have until recently been marketed almost exclusively for parenteral administration.

A limitation of the parenteral route for delivery of peptides and proteins is extremely short half-lives of these drugs - in order of a few minutes. This demands repeated administration, which is inconvenient to patient. For this reason, non-parenteral routes of administration are being pursued, most notably inhalation ( Exubera ) . Another approach is to incorporate controlled release parenteral formulations, where a single injection may release drug over several weeks or longer.

These combination products, where the drug and device are clinically tested and approved as a single product entity, are becoming one of fastest new drug categories. Combination drug delivery products are growing at an annual rate of fourteen percent across all technology segments, and will total $38 Billion in 2008. The growth of combination products is having a significant effect on way drugs and devices are developed. Cooperation between device designers and drug developers is occurring much earlier in drug development cycle, allowing device designs in many cases to be tailored to bioavailability targets and pharmacokinetic profiles of specific drug therapies. The new devices - a group that includes pen injectors and dry powder inhalers - are typically patient-friendly, easing compliance concerns, which have a non-negligible effect on drug formulations and delivery decisions, and are becoming a significant factor in the prescribing decisions of many physicians.

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About Greystone

Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.

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Medical advises for your health improvement

Levitra: useful modern medicine.

uses of Levitra Levitra is used to treat male sexual function problems ( impotence or erectile dysfunction ) by blocking a certain enzyme ( phosphodiesterase-PDE5 ) . In combination with sexual stimulation, Levitra works by helping the blood flow into penis to achieve and maintain an erection.

Levitra isn't indicated for use in women.

Use of Levitra does not protect against sexually transmitted diseases ( e. g. , HIV, hepatitis B, gonorrhea, syphilis ) . Practice " safe sex " such as using latex condoms. Consult your doctor or pharmacist for more details.

how to use of Levitra Levitra is taken by mouth as needed, 1 hour before sexual activity with or without food; or use as directed by your doctor. Don't take more often than once daily as needed.

A high fat meal may decrease amount of drug that is absorbed.

Avoid eating grapefruit or drinking grapefruit juice while we are being treated with Levitra unless your doctor instructs you otherwise.

The dosage is based on your medical condition, response to therapy, and other medications we may be taking ( see also Drug Interactions section ) . Consult your doctor or pharmacist for more details.

Read patient information leaflet provided by your pharmacist and ask questions if any of the information is unclear.

side effects of Levitra Headache, flushing, nasal stuffiness, stomach upset, heartburn, runny nose, dizziness, or nausea may occur while use Levitra. Vision changes such as increased sensitivity to light, blurred vision, or impaired blue/green color discrimination may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Levitra because he or she has judged that benefit to we is greater than risk of side effects. Many people using Levitra don't have serious side effects.

Rarely, a sudden loss of eyesight in one or both eyes ( NAION ) may occur while use Levitra. This may or may not be due to Levitra. If this serious problem occurs, seek immediate medical attention. We have a slightly greater chance of developing this serious eye problem if we have heart disease, diabetes, high cholesterol, certain eye problems ( " crowded disk " ) , high blood pressure, are over 50 years of age, or if we smoke.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur:

Sexual activity may put extra strain on your heart, especially if we have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and tell your doctor immediately of:

For males, in the very unlikely event we have a painful or prolonged erection lasting 4 or more hours, stop using Levitra and seek immediate medical attention, or permanent problems could occur.

Rarely, Levitra may cause sudden hearing problems, or ringing in ears. Stop taking Levitra and tell your doctor immediately if these effects occur.

A serious allergic reaction to Levitra is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

This isn't a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

precautions of Levitra Before taking Levitra, tell your doctor or pharmacist if we are allergic to it; or if we have any other allergies.

Before using Levitra, tell your doctor or pharmacist your medical history, especially of:

Levitra may make we dizzy or cause vision changes; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using Levitra in the elderly because they may be more sensitive to side effects of drug.

Levitra isn't indicated for use in women or children.

interactions of Levitra Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for them. Don't start, stop, or change dosage of any medicine before checking with them first.

See also How To Use section for drug-food interactions.

Levitra shouldn't be used with the following medications because very serious ( possibly fatal ) interactions may occur:

If we are currently using any of these medications, tell your doctor or pharmacist before starting Levitra.

Before using Levitra, tell your doctor or pharmacist of all prescription and nonprescription/herbal products we may use, especially of:

If we are taking ritonavir or nelfinavir, don't take more than a 2. 5mg dose of Levitra in a 72 hour period. If we are taking indinavir or high doses ( 400mg daily ) of either ketoconazole or itraconazole, do not take more than a 2. 5mg dose of Levitra per day. If you are taking erythromycin or low doses ( 200mg daily ) of either ketoconazole or itraconazole, don't take more than 5mg dose of Levitra per day. For more details contact your doctor or pharmacist.

Other drugs besides Levitra which may affect heart rhythm ( QTc prolongation in the EKG ) include dofetilide, pimozide, amiodarone, quinidine, sotalol, procainamide, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details before taking Levitra. Ask for instructions about whether you need to stop any other QTc-prolonging drugs you may be using in order to minimize risk of this effect.

This document doesn't contain all possible interactions. Therefore, before using Levitra, tell your doctor or pharmacist of all products we use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

Levitra with US shipping

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