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Malignant Hypertension and accelerated high blood pressure are two emergency conditions which should be treated promptly. Both conditions have same outcome and therapy. However Malignant hypertension is a complication of high blood pressure ch

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

aracterized by very elevated high blood pressure, and organ damage in the eyes, brain, lung and/or kidneys. It differs from other complications of hypertension in that it is accompanied by papilledema. (Edema of optic disc of eye) Systolic and

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

diastolic blood pressures are usually greater than 240 and 120, respectively. While Accelerated high blood pressure is condition with high blood pressure, target organ damage, on fundoscopy we have flame shaped hemorrhages, or soft exudates,

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ut without papilledema.

There are two things. Hypertensive Urgency and Hypertensive emergency. In hypertensive urgency we don’t see any target organ damage while in emergency we see target organ damage along with high blood pressure greater t

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

an systolic >220. Now depending upon target organ damage you will decide whether you have hypertensive emergency or urgency. It is essential to bring down high blood pressure in hypertensive emergency immediately, while in urgency, bring down

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

blood pressure very rapidly is not required.

Pathogenesis of malignant hypertension is fibrinoid necrosis of arterioles and small arteries. Red blood cells are damaged as they flow through vessels obstructed by fibrin deposition, resulting in

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

microangiopathic hemolytic anemia. Another pathologic process is the dilatation of cerebral arteries resulting in increased blood flow to brain which leads to clinical manifestations of hypertensive encephalopathy. Common age is above 40 years

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

and it is more frequent in man rather than women. Black people are at higher risk of developing hypertensive emergencies than the general population.

Target organs are mainly Kidney, CNS and Heart. So symptoms of Malignant hypertension are ol

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

gurea, Headache, vomiting, nausea, chest pain, breathlessness, paralysis, blurred vision. Most commonly heart and CNS are involved in malignant hypertension. The pathogenesis is not fully understood. Up to 1% of patients with essential hyperte

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

nsion develop malignant hypertension, and the reason some patients develop malignant hypertension while others do not is unknown. Other causes include any form of secondary hypertension; use of cocaine, MAOIs, or oral contraceptives; , beta-bl

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ckers, or alpha-stimulants. Renal artery stenosis, withdrawal of alcohol, pheochromocytoma {most pheochromocytomas can be localized using CT scan of the adrenals}, aortic coarctation, complications of pregnancy and hyperaldosteronism are seco

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

dary causes of hypertension. Main Investigations to access target organ damage are complete renal profile, BSR, Chest Xray, ECG, Echocardiography, CBC, Thyroid function tests.

Management:

Patient is admitted in Intensive Care Unit. An intrav

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

nous line is taken for fluids and medications. The initial goal of therapy is to reduce the mean arterial pressure by approximately 25% over the first 24-48 hours. However Hypertensive urgencies do not mandate admission to a hospital. The goal

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

of therapy is to reduce blood pressure within 24 hours, which can be achieved as an outpatient department. Initially, patients treated for malignant hypertension are instructed to fast until stable. Once stable, all patients with malignant hy

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ertension should take low salt diet, and should focus on weight lowering diet. Activity is limited to bed rest until the patient is stable. Patients should be able to resume normal activity as outpatients once their blood pressure has been con

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

rolled.

Hospitalization is essential until the severe high blood pressure is under control. Medications delivered through an IV line, such as nitroglycerin, nitroprusside, or others, may reduce your blood pressure. An alternative for patients

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

with renal insufficiency is IV fenoldopam. Beta-blockade can be accomplished intravenously with esmolol or metoprolol. Labetalol is another common alternative, providing easy transition from IV to oral (PO) dosing. Also available parenterally

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

are enalapril, diltiazem, verapamil, Hydralazine is reserved for use in pregnant patients as it also increases uterine profusion, while phentolamine is the drug of choice for a pheochromocytoma crisis. After the severe high blood pressure is

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

rought under control, regular anti-hypertensive medications taken by mouth can control your blood pressure. The medication may need to be adjusted occasionally.

Remember, It is very necessary to control malignant hypertension, otherwise it ca

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

lead to life threatening conditions like Heart Failure, Infarction, Kidney failure and even blindness.

Dr Armughan, Author of this article. Read More about Malignant Hypertension

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

So often, we see small business people who need to cut costs because they find that their businesses are in trouble. The first thing they do is cut marketing dollars and their commitment to allocate resources towards marketing.

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