Why Isopropyl Alcohol is Widely Used As a Hand Disinfectant in Pharma?

Isopropyl alcohol will instantly kill 99.99 percent or more of all non-spore forming bacteria in less than 30 seconds, both in the laboratory and on human skin. Iso propyl alcohol is acceptable in pharmaceuticals because they do not leave any residues after drying.The disinfection activity of isopropyl alcohol is significantly lower at concentrations below 50% and is optimal in the 60 - 90% range. 

Isopropyl alcohol have lipophilic properties and can cause membrane damage and rapid denaturation of proteins,with subsequent interference with metabolism and cell lysis.

Isopropyl alcohol is not sporicidal.But it can inhibit sporulation and spore germination.

Which type of caps are preferred in clean rooms?

Bouffant caps are always recommended in clean rooms. A bouffant cap is a cap which completely covers the hair properly so it is preferred in clean rooms,because it is important to avoid loose hairs. They are usually made of polypropylene or some other non-woven material, with an elastic band around the rim to keep it tight around the head below the hairline.These are disposable types of caps.

Bouffant Caps or Bonnets look like shower caps and are designed to cover the hair to protect against dry particulates in nonhazardous environments.A 'bouffant cap' got its name because of its resemblance with  hair style.(Which is characterized by hair piled high on the head and hanging down on the sides)





As they can be worn by any sex and over any hairstyle, bouffant caps are a popular and economical choice of workplace head covering.

PENCIL SHOULD NOT BE USED IN CLEAN ROOMS WHY?

Pencils should not be used in clean rooms because they will generate graphite particles.

ANTIBIOTIC RESISTANT SUPER BUGS AND ASSOCIATED RISKS

From the past several years antibiotics played a crucial role in the fight against many diseases and infections.As the use of antibiotics become more widespread,the prevalence of antibiotic resistant bacteria increased.

Super bugs are germs or pathogens that are resistant to antibiotics.In other words super bugs can survive even though if it is exposed with an antibiotic.Wide spread use of antibiotics played a significant role in the emergence of super bugs (antibiotic misuse creates antibiotic resistant strains).In some countries antibiotics are sold 'over the counter'with out prescription,which also leads to the devolepment of resistant strains.


A spontaneous or induced mutation in  bacteria may confer the resistance to antibiotics.These resistance can be transferred between the bacterium by conjugation,transformation and transduction.Many antibiotic resistance gene reside on plasmids,facilitating the transfer.If a bacterium carries several resistance genes it is called multi drug resistant (MDR) or super bugs or super bacterium. Antibiotic resistant super bugs are spreading quickly all over the world in no time, so life threatening bacterial infections will drastically increase over the next 10 years. 







Mechanism of Antibiotic resistance
Antibiotic resistance can be achieved by either chemical modification of an antibiotic or alternatively render it inactive through physical removal from the cell,or through modification of the target site.The most common mode is the enzymatic inactivation of the antibiotics.Ex: Betalactamse enzymes on betalactum antibiotics.





Bacterial super bugs that have become resistant to different antibiotics are presenting an increasing challenge to the word of health care,and will be one of the leading health problems of this century.The associated problems of super bug infection often lead to longer illnesses,extended hospital stays and some times causes of death.

Hand Disinfection Procedure in Pharma

In pharmaceuticals hands disinfection is considered to be a part of contamination control, because hands plays a major role for transferring microbial contamination from one place to another.Personnels  working in clean rooms can carry many types of microorganisms on their hands and it can be readily transfered from person to person or from person to equipment or critical surfaces.


Alcohols have a long history of use as disinfectant due to their inherent antiseptic properties against some bacterias and virus.Usually in pharmaceuticals 70% IPA (Iso Propyl Alcohol) is used as hand disinfectants.


The technique of hand disinfection is of great importance as the effectiveness is not only with the alcohols but also relates to 'rub - in' technique,which is pictorially given below

When ever doing hand disinfection pay attention to the following areas

• Finger nails
• Back of hands
• Wrists
• Between webs of fingers
• Thumb

After disinfection allow the hands to dry.This should not take more than 60 seconds.Regular application of hand disinfects are required prior to carry out critical operations,because alcohols are volatile in nature and do not provide a continued antimicrobial action.

black box warning

A black box warning is issued by the U.S. Food and Drug Administration (FDA) to inform physicians and patients about any important safety concerns, such as serious side effects or life-threatening risks.In other words it is a type of alert that appears on the pack of certain prescribed drugs.


A black box warning is named for the black border surrounding the text that appears on the package insert, label, and marketing materials that describe the medication.It is the most series type of  warning in prescribed drug labeling which indicates the drug carries a significant risk of series or even life threatening adverse effects.Black box warnings become more prominent in 2004 and got great deal of media attention since then.Currently more than 500 medications in United states carries black box warning.


FDA uses various types of evidence when deciding if a black box warning should be assigned to a medication.The evidence supporting the use of this warning can be obtained directly from randomized-controlled trials during medications approval process.Information received after the medication has already been approved and a particular adverse event is discovered during post marketing reporting can also be used.If new or more frequent adverse event appears after a drug is already on the market,the FDA may also decide to review the data and will then determine if a new boxed warning is  merited.


The FDA's Drug Safety & Risk Management Advisory Committee recently recommended that ADHD stimulant drugs receive a black box warning on their labels to discuss their possible risk of causing high blood pressure, stroke, and sudden death.

Teratogenicity and Pregnancy Category

Teratogenicity is the ability to cause developmental anomalies in a fetus.Agents which cause teratogenicity is known as teratogens (The agent may be a chemical,a drug, an infection,radiations or a maternal condition such as diabetes).And the study of teratogenicity and teratogens are known as Teratology.



Teratogens may cause anything from abnormal development of a limb to malfunction of an organ,and the effects for the developing fetus can vary depending on the teratogen,the gestational age of the fetus,and other factors.A wide range of different chemicals and environmental factors are suspected or known to be teratogenic in humans and animals.A selected few includes tobacco,alcohol,androgenic hormones,X-rays,atomic radiations etc.




Pregnant women are encouraged to avoid exposure to such agents and advised to take care of substances of unknown teratogenicity.The US FDA has established five pregnancy categories (in1979) to indicate the potential of a drug to cause teratogenicity if it is used during pregnancy,which runs from 'category A' (safest) to 'category X' (known danger- do not use).

Category A

These category drugs are generally considered to be safe during pregnancy. Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.Ex: Folic Acid,Vitamin B6 and some thyroid medicines in prescribed doses.

Category B

These drugs are frequently used during pregnancy and do not appear to cause major birth defects or other problems. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).Ex:Paracetamol (acetaminophen),Ondansetron,Metformin etc.

Category C

Studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) but the drugs have not been tested on women.Also includes drugs which have not been tested on animals or humans. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.Ex:Fluconazole

Category D

There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).Ex: Phenytoin.

Category X

Studies in animals or human beings have demonstrated fetal abnormalities, or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.Ex: Statins, Warfarin derivatives etc.

Unfortunately this system over simplifies the issues relevant to prescribing a medication to a pregnant patient.For example there is a tendency to assume that Category B drugs are safer than category C drug when there may be no human studies available to support the assumption.

Drug Patents

When a pharmaceutical company first markets a drug, it is usually under a patent that allows only the pharmaceutical company that developed the drug to sell it.The expiration of a patent removes the monopoly of the patent holder on drug sales licensing.


Patent lifetime differs from country to country,and typically there is no way to renew a patent after it expires.In US drug patents gives 20 years of protection from the date of filling.The standard life time of a European patent is 20 years,calculated from the date of filling.The term for a patent in Japan, China, Korea, and India, is 20 years.In Japan and Korea, in certain circumstances, this period can be extended.


In US patent extension can be granted if changes are made.A new version of the drug with significant changes to the compound could be patented, but this requires new clinical trials.In addition, a patent on a changed compound does not prevent sales of the generic versions of the original drug unless regulators take the original drug off the market. 

What is FDA's Orange Book (Approved Drug Products With Therapeutic Equivalence Equations)

 

FDA ORANGE BOOK (Approved Drug Products with Therapeutic Equivalence Evaluations)

 
“The Orange Book" is actually the U.S. Food and Drug Administration's (FDA) official listing of Approved Drug Products with Therapeutic Equivalences.

 

“Orange book” is published by the FDA's Centre for Drug Evaluation and Research (CDER).The List contains therapeutic equivalence evaluations for approved multisource prescription drug products. Generic drug evaluations contained in the list are designed to serve as public education and advice to physicians, pharmacists and state health agencies, and to help promote access to lower priced medicines.

The Orange Book is divided into four parts: Part one includes approved prescription drug products with therapeutic equivalence evaluations. Part two lists approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs. Part three includes drug products administered by the Center for Biologics Evaluation and Research. Part four includes a list of approved products that have never been marketed, are for export only, are intended for military use, have been discontinued from marketing, or have had their approvals withdrawn for reasons other than safety or efficacy.

The therapeutic equivalence evaluations contained in the list refer to the FDA's criteria for approved multi-source prescription drug products. The evaluations are presented in code letters corresponding to the type of evaluation used. An explanation of the code appears in the introduction to the list. The main criteria for the inclusion of a drug product on the list are that the product has received an effective approval that has not been withdrawn for efficacy or safety or efficacy causes. Inclusion of products on the list is independent of any current regulatory action through administrative or judicial means against a drug product.

Why Generic Drugs are termed "Abbreviated"?

 

Why Generic Drugs are termed "Abbreviated"?

 Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

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