pharmaceutics

Crestor patents found INVALID

2013-03-05T06:25:00.005-08:00

AstraZeneca which is a global biopharmaceutical business with focussed primarily on discoveries, developments and commercialisation of prescription medicine on gastrointestinal, cardiovascular etc. annouced that Federal Court of Australia has found three patents protecting 'Crestor' (rosuvastatin) to be invalid.
these patents i.e. formulation patent (AU 200051842, with an expiry date in 2020); a second related to the use of rosuvastatin for treating heterozygous familial hypercholesterolemia (AU 2002214165, with an expiry date in 2021); and a third related to the use of rosuvastatin for treating hypercholesterolemia (AU 2000023051, with an expiry date in 2020) - were challenged by Apotex Pty Ltd, Watson Pharma Pty Ltd and Ascent Pharma Pty Ltd.

The Federal Court decision is limited to Australia and has no impact on the validity of patents related to CRESTOR in other countries nor does it have any impact on AstraZeneca's financial guidance for 2013, which will, in accordance with normal practice, be reviewed in conjunction with the announcement of First Quarter Financial Results on 25 April 2013.
Total sales of CRESTOR in Australia for 2012 were approximately $350 million.AstraZeneca is disappointed in the court's decision to find these patents invalid. The company remains committed to defending its intellectual property protecting CRESTOR in Australia and is carefully reviewing this decision and evaluating all legal options at this time, which could include filing an appeal and seeking to maintain existing preliminary injunctions

Efficacy of Expiry Dated Drug Products

2012-12-12T01:07:00.001-08:00

Drugs are never been used after they met their expiry dates. But according to scientists some drugs product which may be over-the-counter drugs or from other category may be used even after the their expiration. In this context U.S. Military performed a million dollar research on the efficacy of the drug products with expiry date all about 27 years ago on more than 100 products available in the market at that time. And a the research succeeded scientists were surprised with the results which proves that 90% of the drugs can be used even after the expiry date with the same efficacy.

So, Again the question was that why the companies mention the expiry dates if drug can withstand their efficacy for such a long time.
whatever will be the reason but research over this concept is a bit under controversy as it is a multi billion market which growing yeay after year and also is related with the human welfare

Tudorza Pressair (aclidinium bromide): Approved by US FDA

2012-07-24T02:55:00.004-07:00

Tudorza pressair i.e. aclidinium bromide recently approved by the US FDA which is very good bronchodilator long term management of the brochospasm which generally occurs due to bronchospasm (narrowing of the airways in the lung) which normally associated with COPD (chronic obstructive pulmonary disease), including chronic bronchitis and emphysema.

In case of COPD, it makes it difficult to breathe.
There are two main forms of COPD:

Chronic bronchitis, which involves a long-term cough with mucus
Emphysema, which involves destruction of the lungs over time

Most of the patients with COPD have a combination of both the conditions.
COPD is caused by noxious particles or gas, most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lungs.
“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research.
“The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease.”

The safety and efficacy of Tudorza Pressair were demonstrated in three randomized, placebo-controlled confirmatory clinical trials that included 1,276 patients ages 40 and older with a clinical diagnosis of COPD. Those treated had a smoking history of at least one pack a day for 10 years.

Tudorza Pressair may cause serious side effects, including paradoxical bronchospasm, new or worsened increased pressure in the eyes (acute narrow-angle glaucoma), or new or worsened urinary retention. Tudorza Pressair should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years.
Side effects reported by patients using Tudorza Pressair include headache, inflammation of the nasal passage (nasopharyngitis), and cough.

Currently, Tudorza Pressair is distributed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.

Source: US FDA

Lipitor : Best selling drug in Pharmaceutical History

2012-07-11T00:25:00.001-07:00

Lipitor, a drug by Pfizer boomed up the sale of the pfizer in past years of its patent period and recorded as best selling drug in history of pharmaceutical industry. Lipitor is a brand name of drug Atorvastatin calcium developed and patented by pfizer and patent expired last year in november 2011. It is called as The Blockbuster Drug due to its sales profile. Its sales of more than $10 billion worldwide last year. Also, overall business of this particular drug was accounted as high as more than $130 billion. Lipitor, is a statin class of drug helps to reduce High Cholestrol level in blood, thus, administered in case of stroke, heart attack and other cholestrol related problems.

As patent got expired last year in November 2011, after that the field was opened for the other biggies of pharmaceutical industries to manufacture the generic form of lipitor (Atorvastatin calcium) and promote the sale of cheap products of the atorvastatin as compared to lipitor price in past.

Now, an Indian MNC launched its own generic product of atorvastatin as Atorvastatin Calcium is Ranbaxy Laboratory in December 2011 at a very reseonable price. Also, other companies like Cipla and TEVA also launched their Atorvastatin calcium formulations in UK market and around the world at very reasonable price. So, finally it was a good farewell for a best selling blockbuster drug which made and broke many records with respect to the money and all. So, overall, it is a good news for the patients with low finance backgroud that they can now consume a best statin drug of all time at a reasonable cost.

Patent Expired Drugs in 2012 and 2013

2012-07-10T10:55:00.000-07:00

In current year, about 25 drugs are there whose patent going to be expired in United kingdom.
the drugs whose patent expired or yet to be expired in 2012 are listed below as:

Patents expiring in 2012

Approved Name	BNF	UK-patent expiry
Atorvastatin ¨	2.12	06/05/2012
Bemiparin«	2.8.1	21/07/2012
Candesartan«	2.5.5.2	28/04/2012
Cidofovir	5.3.2.2	22/04/2012
Desogestrel «	7.3.2.1	11/12/2012
Dipyridamole + Aspirin «	2.9	08/07/2012
Donepezil HCl «	4.11	13/02/2012
Doripenem «	5.1.2.2	17/08/2012
Entacapone «	4.9.1	26/11/2012
Eprosartan mesylate «	2.5.5.2	14/04/2012
Eptifibatide «	2.9	26/02/2012
Galantamine «	4.11	15/01/2012
Indinavir	5.3.1	01/11/2012
Irbesartan «	2.5.5.2	14/08/2012
Latanoprost ¨	11.6	17/01/2012
Lepirudin «	2.8.1	12/03/2012
Mometasone furoate «	3.2	18/02/2012
Naratriptan «	4.7.4	09/03/2012
Quetiapine fumarate «	4.2.1	23/03/2012	including XL formulation
Rabeprazole «	1.3.5	12/11/2012
Ramipril + Felodipine «	2.5.5.1	18/09/2012
Rivastigmine hydrogen tartrate«	4.11	30/07/2012
Tolcapone «	4.9.1	24/02/2012
Tolterodine tartrate «	7.4.2	04/09/2012
Zolmitriptan«	4.7.4	06/03/2012

« drugs with SPC extension

¨ drugs with SPC paediatric extension

other drugs whose patents will be expire in year 2013 are:

Patents expiring in 2013

Approved Name	BNF	UK-patent expiry
Basiliximab «	8.2.2	06/04/2013
Capecitabine «	8.1.3	09/06/2013
Clopidogrel hydrogen sulphate¨	2.9	15/08/2013
Dorzolamide + Timolol «	11.6	05/03/2013
Efavirenz «	5.3.1	19/11/2013
Etonogestrel «	7.3.1	06/07/2013
Fosphenytoin sodium «	4.8.2	03/02/2013
Hydroxyethyl starch «	9.2.2.2	19/11/2013
Irbesartan +hydrochlorothiazide«	2.5.5.2	14/10/2013
Montelukast sodium ¨	3.3.2	24/02/2013
Nelarabine «	8.1.3	26/05/2013
Nevirapine ¨	5.3.1	22/06/2013
Raloxifene HCl	6.4.1.1	04/08/2013
Rituximab «	8.2.3	21/11/2013
Rizatriptan ¨	4.7.4	10/08/2013
Salmeterol xinafoate+ Fluticasone propionate «	3.2	06/09/2013
Sildenafil «	2.5.1/7.4.5	21/06/2013
Telmisartan «	2.5.5.2	10/12/2013
Tirofiban HCl «	2.9	27/05/2013
Zidovudine + Lamivudine «	5.3.1	17/03/2013
Zoledronic acid ¨	6.6.2	15/05/2013

« drugs with SPC extension

¨ drugs with SPC paediatric extension

So, these are drugs drugs whose patents were expired or will be expire in future. So, these drugs will be good for those who like to research on new drugs like Pharmacy scholars.

M-Pharmacy Projects

2012-07-10T10:43:00.002-07:00

A working time for Master in Pharmacy students is now going to begin in next few days. it is quite often that your guide must give to work on literature for selection of few drugs and topic on which you like to work in part II of
M-Pharmacy. It is natural that some students or we can say that many students do not know how to get in the selection, how to select, what points should taken under consideration when going to select a drug for research program. So, it would be helpful for those students to discuss few points which may help them to select their relative drug for purpose of research.

Which Drug To Be Selected:
It is very important that what makes you excited to work with. many student already had a picture of kind of drugs they like to work on like anti-cancer drugs or some anti-viral or any other class. But, it should be consider that you should complete your project work in 1 year. So, if anyone wants to work with any drug of their interest it should be well defined in literature, otherwise it will be a nightmare to you. alog with this, drug should be such, that its pure form should be available easily otherwise to explore its sources and manufarer consumes a big time which a research scholar can not afford. alog with these points you should take one point under consideration is Pharmaco-economical base of drug i.e. cost of pure drug should not be too high that after spending your precious time on all workings and literature review, you have to leave that drug just because its too much expensive. So, after selecting drug and before starting literature review one should have to go for overviewing the pharmaco-econimics of the pure drug. Other thing is that the whatever you wi;; going to select its pure form or crude form should be available in ready-made form for e.g. if someone like to work on a drug whose one form shows less efficacy say its amorphous form then to work on its crystalline form drug crystalline form should be available easily in readymade form.

Also, before undergoing searching of drugs on internet and other sources one can also look for the drugs whose patent going to be expired in future or got expired in past 1 or 2 years because for such drug alot of work you can do with respect to the problems with its innovators formulation.

Literature Review:

After completion with your selection of the drug you will going to take for your project work after discussion and approval with your guide you have to step forward toward the literature review of the drug you selected.

For any drug you had selected you should look forward for following points for your work-

Any significant pharmaceutical problem with the drug product related to its formulation, drug delivery and bio-availability.
Methods and types of dosage form which already exsits in the market.

Points you have to study and review for literature purpose:

One should have to study the history of the drug thoroughly.
Early and common problems related to exsisting dosage forms.
complete data base of drug available by any source like internet, libraries etc.
Complete physico0chemical parameter of pure drug.
Study of complete drug profile from authenticated sources like pharmacopoeias, FDA online sites etc.
study of depth of the drug and its available formulations and problems related with that available problems.

So, finally with the help of these discusses point you can make your selection more easy and fast to work on your project in master of pharmacy part II.

Scope of Pharmacy!!!!

2012-06-25T22:48:00.001-07:00

Hello Everyone,
GPAT Entrance Examination results are out a few weeks back and students trying to get in the best college to secure there future.

Now What?
It is now important for students who freshly engaging in pharmacy field to know that this field is alot challenging as it demands hard work, focuusing and most important patience. After all this I want to say that this field has infinite opertunities for those who are talented hard working and have patience. you have many departments to work with after completing B- Pharmacy like marketing i.e. M.R. QUALITY ASSURANCE, QUALITY CONTROL etc. Moreover, someone can earn by themself if not intrested in the job or having some problem by openong their pharmacy shop. The best part for pharmacy students is that they can deal any kind of business related with drugs and medicines.

PHARMACIST IN CLINICAL RESEARCH!!!
One of the fastest emerging field in India now a days is clinical research. Clinical Research has wide scope for the pharmacist and also provides with a good salary package and appraisals. Here you have to work with doctors comply with patients and generate data of drug under invetigation. In India Clinical Research is gaining attention of pharmaceutical industries and R & D department of these companies as country provides a wide ranges of human with difference in their livings, physical status ang genetic behaviour. Also, along with all this country witj such a vast number of patients and dense population of India provides all parameter for research purposes.

Masters in Pharmacy
If anyone intrested in scientific career build up and like to engaged in research field then M- Pharmacy will be the choice after completing the bachlors. Master in Pharmacy posses many fields in pharmacy to deal with like pharmaceutics, medicinal chemistry, pharmacology, pharmacognosy and now a days gaining intrest is M. Pharmacy in regulatory affairs.

Doctorate in Pharmacy or Pharma D

It is six year course after 12th and 3 year after B.Pharmacy. A reputed course after with a pharmacist will be a doctor and have authority to deal directly with paitents and prescribe them medicine. In India, many colleges are there providing this course but only in south and middle region of country.

So, best of luck to everyone who engaged or going to join the pharmacy.

Pharma D: Doctorate in Pharmacy

2012-06-25T00:37:00.001-07:00

A ‘Doctorate In Pharmacy’ is a proffesional degree course introduced in India in year 2008. The course generally is of 6 years of duration( i.e. 5 years of academics and 1 year of intership training duration). Also, for the students completed with the Bachlor Of Pharmacy Post baccaluerate course is there with 3 years of duration (i.e. 2 years of academics and further 1 year of intership). In India, the concept of Pharma D strikes to PCI ( Pharmacy Council of India, when in year 2003, US government refuses the applications of Indian Pharmacists to get registered under the US pharmacy Authority. Also, students with pharmacy background like to serve the patient by prescribing the medicine etc. as done in the developed countries, but this right of prescribing medicine are always with the doctors with medical degree of MBBS, BHMS etc. Currently in India there are only few states, who works under the pharma D programme, including Andhra Pradesh, Karnataka, Tamil Nadu, Madhya Pradesh and Maharashtra. In case of North India pharma D concept in the Univesities was not that successful as in case of the states of south India, In north india currently there is not any university which is running Pharma D in past years of 2008 – 2011. This may be happened due to lethargic behavior of PCI for taking intrest to spread the course all over India colleges.

New advancements in tablet DDS: Orodispersibles

2012-06-16T05:57:00.001-07:00

In recent times, big players of pharmaceutical backgroud focussed toward developing new DRUG DELIVERY SYSTEM, to advance their formulations and medicines with respect to their competitors, results of such need of these biggies is developement of Mouth dissolving tablets or called as Orodispersible tablets. These tablets dissolves in the mouth rapidly and continuously. Such formulations are provided with some of excipients with super behaviour like super dispersibles, super disintegrants etc. Benefit of these tablets over conventional tablets is that they rapidly dissolves in mouth with or without water. Due to this, these are more appropriate for pediatric and geriatric patients who have problems with respect to swallowing. Therefore more focuss is been given by the companies to maximize the patient compliance specially in old age patients with the help of these kinds of formulations. Orodispersibles when administered orally rapidly disintegrates and absorbs from mouth thus, eliminates the chances of 1st pass metabolism also. Thus improving the efficacy of the drug.

Proud to be Pharmacist for serving the country...

2012-06-11T07:05:00.002-07:00

All pharmacist should be proud for serving the country and its need people suffering from diseases.