Effervescent tablets

Effervescent tablets are uncoated tablets that generally contain acid substances and carbonates or bicarbonates and which react rapidly in the presence of water by releasing carbon dioxide.(Effervescent tablets give off bubbles when they dissolves) Effervescent tablet is a tablet intended to be dissolved or dispersed in water before administration.They are good alternatives for dysphagic (who can't swallow tablets) patients.


Effervescent tablets mainly consists of 3 components.
1.API
2.Acid Source
3.Alkaline compound constituted by a carbonate or bicarbonate

Effervescent tablets can be used when 

1.Drugs are difficult to digest or disruptive to the stomach such as calcium carbonate tablets.

2.pH sensitive drugs such as amino acids and antibiotics 

3.Drugs requiring a large dose.

In normal tablet or powder calcium carbonate dissolves in the stomach acid and carried in to the digestive system for absorption.How ever calcium carbonate releases carbon dioxide when it dissolves in the gastrointestinal tract which usually produce gas in the stomach.As people age they have less acid in the stomach and thus a calcium carbonate tablet mass pass through the stomach without dissolving,that it turn may leads to constipation.However if the calcium carbonate is taken in an effervescent formation,the calcium dissolves in water,is readily available for the body to absorb,and there is no risk of excessive gas in the stomach or of constipation.

The low pH in the stomach can denature the API,lose activity or cause them to remain inactive,such as amino acids and vitamins.Effervescent ingredients however,can buffer the water active solution.So that the stomach pH increases and thus prevents the degradation or inactivation of API.

What is the difference between dissolution and disintegration

 

What is the difference between dissolution and disintegration?

 

Disintegration time is the time required for a dosage form to break up in to granules of specified size (or smaller) under carefully specified conditions.

 
Where as dissolution is a process by which solid substance enters in the solvent to yield a solution. It is controlled by the affinity between the solid substance and the solvent.

 
In other words DT (disintegration time) is measuring the break down of a dosage form and dissolution is measuring the drug being solubilized in the media.

Disintegration is a subset of dissolution.It is a process where by the oral dosage form falls apart or disintegrates in to smaller aggregates (disintegration is a disaggregation of constituent particles before dissolution happens).

 

Availability of a drug from the dosage form depends on it's ability to disintegrate fast enough in the existing dissolution media(Rate of drug dissolution is greatly influenced by disintegration of dosage form).

For pharmaceutical articles related to disintegration and dissolution, log on to pharmatreasures.blogspot.com

Disintegration Test - Pass/Fail Criteria

Disintegration Test - Pass/Fail Criteria

 

 

Disintegration Test - Pass/Fail Criteria

 

 

Disintegration

If one or two tablets/capsules fails (out of 6) to disintegrate completely, repeat the test on additional 12 units: not fewer than 16 of the total 18 units tested shall disintegrate completely*

 

*According to chapter <701> of the USP, complete disintegration is defined as “...that state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the screen of the test apparatus or adhering to the lower surface of the disk, if used, is a soft mass having no palpably firm core.”

 For pharmaceutical articles related to disintegration, log on to pharmatreasures.blogspot.com

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.