Sunday, December 22, 2013

THREE-DAY DIETS

 THREE-DAY DIETS

Definition

There are a variety of three-day diets that circulate from person to person and on the Internet. They tend to promise weight loss of 10 lb. (4.5 kg) or more in just three days.

Origins

The origins of the three-day diet are unclear. Some people believe that they go back to the 1980s when these kinds of diets were faxed from person to person. Three-day diets go by many different names, including the fax diet, Army diet, Navy diet, Cleveland Clinic diet, and many others. Often they are just referred to as three-day diets. Although many versions of this diet are named after medical institutions, no medical institutions claim responsibility for or recommend these diets. Institutions such as the British Heart Foundation and the Cleveland Clinic have issued statements that they do not support the three-day diet.

Description

There are many versions of the three-day diet in circulation. All of them promise significant weight loss in just three days, but there are many variations in what dieters may and may not eat during these three days. One diet calls for dieters to drink only water for the first day. On the second day dieters may eat fruit and drink only fruit juice, and on the third day dieters may eat only vegetables and drink only vegetable juice.
The most common three-day diet—and the one that seems to be the most popular—is a three-day meal plan that instructs dieters on what to eat for breakfast, lunch, and dinner. The specifics of the plan vary, as do what dieters are allowed to drink while on the plan. Some versions allow anything, while others specify just water and diet soda, in addition to the coffee and tea called for in the meal plan. Many require that dieters drink at least four glasses of water daily. Some allow diet soda to be substituted for the water.
A common version of the diet is:

DAY ONE.
  • Breakfast: black tea or coffee, half of a grapefruit, one piece of toast with one tablespoon of peanut butter. Some versions specify one-third of a grapefruit, some call for artificial sweetener to be added to the coffee, and some allow grapefruit juice to be substituted for the grapefruit.
  • Lunch: one-half cup tuna, one piece dry toast, black coffee or tea. Some versions call for tuna in water, and some call for artificial sweetener with the coffee or tea.
  • Dinner: three ounces lean meat, one cup green beans, one cup carrots, one apple, one cup vanilla ice cream. Some versions specify a low-fat ice cream, other do not. Some versions call for one cup of beets instead of carrots.
DAY TWO.
  • Breakfast: one egg, one slice dry toast, half of a banana, black coffee or tea. Some versions require artificial sweetened in the coffee or tea. It is not generally specified how the dieter should prepare the egg. Some versions call for a whole banana.
  • Lunch: one cup cottage cheese and six Saltine-brand crackers. Some versions allow dieters to choose between one cup of cottage cheese and one cup of tuna. Some require six crackers, some allow eight.
  • Dinner: two hot dogs, one cup broccoli, one-half cup carrots, half of a banana, one-half cup vanilla ice cream. Some versions specify beef franks. Some call for one cup of cabbage instead of one cup of broccoli. Some versions require low-fat ice cream.
DAY THREE.
  • Breakfast: one apple, one ounce cheddar cheese, five Saltine crackers, black tea or coffee. Some versions allow or require artificial sweetener.
  • Lunch: one hard-boiled egg, one slice dry toast. Some versions allow black coffee or tea (with or without artificial sweetener) with this meal, others do not.
  • Dinner: one cup tuna, one cup carrots, one cup cauliflower, one cup melon, and one-half cup vanilla ice cream. Some versions call for half of a cantaloupe instead of one cup of melon. Some versions require low-fat ice cream.
There are other versions of the three-day diet, with some specifying even more alternatives for the dieter, including an orange instead of grapefruit, cottage cheese instead of tuna, and various vegetable substitutions. Most versions tell dieters to use lemon, salt and pepper, mustard, vinegar, herbs, soy sauce, ketchup, Worcestershire sauce, and other seasonings to add flavoring to the food, but nothing containing fat, such as butter.

Function

The three-day diet usually promises dieters that they will be able to lose ten pounds in three days if the diet is followed exactly. Often the diet claims that the combination of foods called for by the diet causes some kind of increased metabolism that will burn pounds of fat. It is never made clear exactly what kind of reaction this is supposed to be or how it is supposed to work. The three-day diets are intended to provide a dieter with extreme weight loss in a very short time and are not intended to change the dieters lifestyle or overall eating habits. Usually the diets go so far as to tell a dieter to eat whatever he or she was eating before the diet once the diet is over. No exercise recommendations are made with three-day diets. Weight loss is supposed to occur from increased metabolism and lowered calorie intake alone.

Benefits

There are many benefits to weight loss if it achieved at a moderate pace through healthy eating and exercise. Three-day diets, however, are not considered moderate and do not include exercise or a well-balanced diet. Any weight lost on a three-day diet is likely to come from lost water weight and may be quickly regained once the diet is over.

Precautions

Three-day diets are not recommended. Anyone thinking of beginning a new diet should first consult a physician or other medical professional. Daily requirements of calories, fat, and nutrients can differ significantly from person to person depending on age, weight, gender, and other factors. Talking to a doctor can help people determine which diets best fit their individual needs and long-term weight loss goals. Pregnant or breastfeeding women should not attempt to lose weight or engage in fad diets.

Risks

There are some risks associated with any diet, but diets that severely limit calories or the variety of foods that dieters may eat tend to be more risky than well-balanced, moderately calorie-reduced diets. The body needs food from each of the food groups every day for good health. Drinking only fruit juices or eating a very limited variety of foods can make it nearly impossible for a dieter to get all of the nutrients required for good health.
The most common three-day diet requires dieters to eat only about 1,000 calories per day, with some versions consisting of as few as 700 calories per day. This is not enough for most people to maintain good health. A diet that contains fewer than 800 calories per day is considered a very low-calorie diet. Very low-calorie diets carry high risks of side effects, such as gallstones and cardiovascular problems. Very low-calorie diets are intended only for people who are experiencing significant medical problems due to obesity. These diets are carried out under the close supervision of physicians. They are not intended or safe for people to follow on their own.
Dieters who follow a three-day diet may find that any weight lost is gained back as soon as the diet is over, and may even find that more weight is gained than was lost. Maintaining a very low caloric intake slows down the metabolism because the body thinks that it is starving. When a normal number of calories are reintroduced into the diet, the body wants to store extra fat in case there is a period of starvation again. This natural defense mechanism of the body against starvation can cause dieters who alternatively eat very few calories and then return to normal eating to gain large amounts of fat over time, even while they are trying to diet. Very low-calorie diets may also result in binge eating once the diet is over.

Research and general acceptance

Three-day diets are not healthy nor effective for long-term weight loss. Experts suggest that anything that promises dieters 10 lb. (4.5 kg) of weight loss in three days is unlikely to be taking off fat. Instead, dieters are probably losing water weight, with minimal fat loss at most and some muscle mass lost through the reduced caloric intake.
The U.S. Department of Agriculture makes recommendations for a healthy diet in its MyPlate guidelines. MyPlate provides recommendations about how many servings of each food group are required daily for good health. These recommendations can be found at ChooseMyPlate.gov. The guidelines are more realistic than those of the three-day diet. Sustainable diets should not be extremely restrictive or extremely calorie reduced.
Many studies have shown that exercise and diet are more effective at producing weight loss when done together than when either is done alone. Three-day diets do not usually have any exercise recommendations. Instead, they generally claim that a combination of foods will “magically” melt away fat. This is a false assumption, and healthy weight loss plans should include both a diet and an exercise component. The U.S. Centers for Disease Control and Prevention recommends that adults get a minimum of 30 minutes of light-to-moderate exercise each day for good health.

Resources

Larsen, Laura, ed. Diet and Nutrition Sourcebook. Detroit, MI: Omnigraphics, 2011.
Willis, Alicia P. ed. Diet Therapy Research Trends. New York: Nova Science, 2007.
British Heart Foundation. “Healthy Eating.” http://www.bhf.org.uk/heart-health/prevention/healthyeating.aspx (accessed August 10, 2012).
Stevens, Melissa. “Cleveland Clinic Diet.” Cleveland Clinic. http://my.clevelandclinic.org/heart/prevention/askdietician/clevelandclinicdiet.aspx


Thursday, December 19, 2013

Friday, December 13, 2013

गेहूं सड़ता नहीं सडाया जाता है ...!




गेहूं सड़ता नहीं सडाया जाता है ...!
फिर उसको कौड़ियों के भाव
शराब बनाने वाली कंपनियों को बेच दिया जाता है...!

इस देश में करोड़ों लोगों ऐसे हैं
जिनको पूरे जीवन में एक बार भी भरपेट भोजन नसीब नहीं होता
कल पेट भर के खायेंगे
इसी आस में उनकी जिंदगी कट जाती है... !


दूसरी तरफ
वह गेंहूँ ....जिसपर सरकारी सब्सिडी दी जाती है...
वह गेंहूँ ... जिसे ऊँचे दामों पर सरकार खरीदती है
वह गेंहूँ.....जो राशन की दुकानों से होता हुआ सस्ते दर पर गरीबों की थाली तक जाना चाहिए ..
वही गेंहूँ ....बारिश की बूंदों के साथ रिस रिस कर शराब की हरी नीली बोतलों में सीलबंद होकर प्यालों में नाचने लगता है....!
गरीब ...फिर ठगा का ठगा रह जाता है..!!

कब तक चलेगा ऐसा...
भारत माँ का ही एक बेटा ...कब तक भूखे पेट सोयेगा...!!

Solvent Considerations In Solid – Dose Manufacturing



Solvent Considerations In Solid – Dose Manufacturing

Solid-dose tablet and capsule manufacturing is a mainstay of the pharmaceutical industry, as it results in a consistent, effective, and economical platform for drug delivery. Not only are tablets and capsules convenient and easy for consumers to handle, they are also very stable and have a high throughput, offering benefits to both consumers and pharmaceutical companies alike. Technological advances, combined with increasingly potent active pharmaceutical ingredients (APIs), have resulted in the availability of complex delivery systems such as controlled- and extended-release tablets and capsules that enhance therapeutic efficacy while minimizing adverse events.1 Although the number of novel APIs available for development has decreased, the complexity of solid-dose formulations has dramatically increased. Moreover, as complex, brand-name medications reach the end of their product lifecycle, generic equivalents will need to be produced that meet the same technology-enhanced high quality standards. This paradigm necessitates a greater flexibility on behalf of the manufacturer in order to meet the production requirements of a wide range of drug formulations while maintaining efficient and cost-effective manufacturing processes.

For many pharmaceutical companies, both large and small, this has meant moving away from all-inclusive, in-house operations and partnering with Contract Development and Manufacturing Organizations (CDMOs) to meet these new development and manufacturing challenges. The approach to pharmaceutical production itself has also shifted in certain areas, including the mindset around solvent-based technologies. Organic solvents were once commonplace in pharmaceutical manufacturing; from the synthesis of active pharmaceutical ingredients to the formulation of drug products.2 Concerns surrounding workplace and environmental safety resulted in a move to water-based processing for wet granulation and coating during the formulation of relatively simple API-containing solid-dosage forms. However, in light of the aforementioned advances in solid-dose technology, the pendulum is once again swinging. Certain product characteristics, as well as practical production considerations, may preclude the use of water and necessitate the introduction of organic solvents to facilitate development and manufacturing. For example, the production of moisture-sensitive products can require solvent-based systems. In addition, the application of a polymer-based coating for modified-release tablets or pellets could take up to 4 to 5 times longer using an aqueous-based compared with a solvent-based platform, as more energy is required to evaporate water than organic solvents. Furthermore, the deterioration of moisture-sensitive drugs during granulation or coating processes could be increased with aqueous systems.
While these examples serve to demonstrate the practical need for solvent processing in pharmaceutical production, they do not negate the safety concerns that need to be addressed. Residual solvents have no therapeutic benefit and may pose hazardous to human health and the environment. Moreover, the presence of even small amounts of these chemicals may influence the efficacy, safety, and stability of the pharmaceutical products. Although there has been a shift away from the use of the highly toxic solvents, rigorous quality assurance processes and regulatory requirements remain integral in the manufacturing of pharmaceutical agents to ensure quality, consistency, and minimal environmental impact.
If you are looking to outsource your solvent-based solid-dose manufacturing, important considerations should be addressed when researching potential CDMOs to ensure that they can safely and efficiently meet all related needs. Although these considerations are not intended to replace the quality assurance standards that you have in place, they provide a guide to increase the confidence you have in your manufacturing partner.
It goes without saying that your CDMO of choice should have a documented history of solvent-based technology that results in consistent pharmaceutical products manufactured in a safe, certified environment.

Solvent-based capabilities

Solvent capabilities in both granulation/coating solutions used in production


Solvent-based production processes include:

o Wet/high-shear granulation
o Fluid bed processing, including granulation, particle coating, and Wurster coating
o Tablet coating in side-vented pans (eg, used for osmotic delivery systems)
A low-risk solvent-based manufacturing approach starts with the specialized equipment used and the environment in which production is performed. A good rule of thumb is that anything that comes into contact with solvent vapor needs to have solvent-capable (XP) properties.

Equipment installation in a dedicated production space

- Proper installations should be engineered to meet all established requirements to minimize risks to all stakeholders (eg, the worker population, the customer) and the environment
- Equipment should be installed in a room designed to meet stringent Class 1 Division 1 standards for optimal risk mitigation; surrounding areas should also meet these standards
- All controls need to be sealed and/or flushed with air

Dedicated, solvent-capable equipment

- Solvents should be run only in XP equipment. This includes pumps, mills, and ancillary equipment in the immediate surrounding area
- Appropriate preventive maintenance should be performed on all solid-dose equipment to ensure that it operates at designed levels
- Continued engineering support ensures that the equipment’s utilization can be maximized throughout its lifetime

Effective methods of solvent abatement

- Effective means must be employed to abate the exhaust air, which is highly solvent laden, to meet all appropriate regulatory standards for the site
- A thermal oxidizer in order to physically burn the solvents or scrubbers to remove the solvents from the exhaust gases

Quality-based requirements

- Residual solvent levels must be assured using appropriate testing to meet USP Guidelines3
- Manufacturers should be in regular contact with state and federal authorities to ensure appropriate emission licensure
In conclusion, solvent-based technology represents an important function in the manufacturing of solid-dose pharmaceutical formulations. CDMOs with a well-engineered and well-executed approach to handling solvents allow for the efficient and safe production of highly effective therapeutic formulations that may otherwise be unavailable to patients in need. When choosing a CDMO, it is important to explore the options available before committing to a partner. Begin by gaining an understanding of their specific capabilities and expertise, and thoroughly review the variables that are important for safe and efficient production processes.

References

1. Dey NS, Maunder S, Rao MEB. Multiparticulate drug delivery systems for controlled release. Trop J Pharm Res. 2008;7(3):1067-1075.

2. Grodowska K, Parczewski A. Organic solvents in the pharmaceutical industry. Acta Pol Pharm. 2010;67(1):3-12.

3. USP 35–NF 30, General Chapter <467> Residual Solvent/Organic Volatile Impunities, 2012





What is regulatory Affair?

Protection of public health is the fundamental purpose Regulation.
A regulatory affair is a profession which protects the public health by controlling the safety and efficacy of products such as pharmaceuticals, medical devices, veterinary medicines pesticides, agrochemicals, cosmetics and complementary medicines1.
Although protection of public health appears simple goal, it can achieve only through extensive and complex regulation. Safety, Efficacy, Purpose, Risk/benefit and Quality are the core principles on which regulation rely2.



Why Regulatory?

Drug Regulatory Affair Department is the BACKBONE of Pharmaceutical Industry. It is revenue generator for Industry.
The Regulatory Affairs department is an important part of the pharmaceutical companies. Internally it cooperates with other department like drug development, manufacturing, marketing and clinical research. Externally, it is the key interface between the company and the regulatory authorities.
Regulatory Affairs is involved in the development of new medicinal products, by applying regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities.
Regulatory Professional obtains the marketing authorization for the product by presenting the registration document to regulatory agencies, and making the necessary subsequent negotiations.
They contribute in the commercial and scientific success of the product development by giving strategic and technical advice, from the beginning of the product development.
More than 15 years span is required to develop and launch a new pharmaceutical product in the market. During this scientific development many problems may arise.
This process can make fast by avoiding and solving the problem at appropriate steps only with the help of Regulatory Professional. They help the company for keeping proper records, appropriate scientific thinking, update with always changing regulatory guidelines/requirements and proper presentation of data.
Some Important Drug Regulatory Authorities (across the world)

Each and every country has its own regulatory body. Some important authorities among them are mentioned below along with their country name.

1. CDSCO- India
2. USFDA- United States of America
3. EMA-European countries
4. MHRA- United Kingdom
5. Health Canada- Canada
6. TGA- Australia
7. MCC- South Africa
8. ANVISA- Brazil
9. Medsafe- New Zealand


Scope of Regulatory Affair


1. Proper development of the Product.
2. Assuring efficacy, safety, and quality of the product.
3. Review in house documentation & updating other departments.
4. Proper packaging and labeling.
5. Dossier filling/ product submission and getting approval from health agency within specified time period.
6. Making smooth roadways for placing quality product in market.
7. Helping Pharmaco-vigilance of quality/ safety issue post marketing.




What documents Regulatory Professional Prepare?


1. Internal Regulatory Standard Operating Procedure (SOP)
2. New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (INDA) submission documents.
3. Drug Master File (4US type I to V, Canadian, Open and closed part for EU and other market)
4. Dossier for different submission- 5Common Technical Documents (CTD) / Asian CTD (ACTD)/ non-eCTD electronic submission (NeeS)/ 6Electronic CTD (eCTD)/ Country specific dossier.


References:

1. http://www.topra.org/careers/what-regulatory-affairs
2. John J. Tobin and Gary WalshMedical Product Regulatory Affairs page no 15
3. http://www.authorstream.com/Presentation/luckylove06021987-631120-drug-r...
4. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequi...
5. http://www.ich.org/products/ctd.html

6. http://www.ich.org/products/guidelines/multidisciplinary/article/multidi...

ACCELERATED STABILITY AND ANTIMICROBIAL SENSITIVITY STUDIES OF AMOXICILLIN DRY SUSPENSIONS

ACCELERATED STABILITY AND ANTIMICROBIAL SENSITIVITY  STUDIES OF AMOXICILLIN DRY SUSPENSIONS

   ABSTRACT    

ince its introduction, amoxicillin dry suspension has been the mainstay for the  antibacterial therapy for paediatric patients. But use of substandard preparation of antibiotic is  one of the most important causes of microbial resistance. The present study has been carried out  to evaluate the quality and stability status of 10 marketed amoxicillin dry suspensions of  Bangladesh. All the brands were analyzed for their potency using chemical and microbiological  methods described in the United States Pharmacopoeia and British Pharmacopoeia. Potency  determination was done at three controlled temperatures - refrigerated, room and elevated (40.C)  showed that two samples were over potent but one sample was substandard out of the 10  samples. The initial potencies of the two samples were within USP range when freshly  reconstituted but after 7 days, at room temperature, potencies deteriorated and came down to  90%. In refrigerated condition, all the samples remained in good condition and at 40.C, a  considerable loss of potencies in all the samples were observed. Results of microbiological assay  also support the results of chemical assay. The study emphasizes the necessity of routine  inspection, monitoring and evaluation of quality of formulations containing amoxicillin dry  syrup.      Keywords: Amoxicillin, dry suspension, paediatric patients, substandard, reconstituted.

  

  INTRODUCTION     

Bangladesh is a developing country where a significant proportion of the total population  lives down the poverty line and cannot afford for appropriate medical care, adequate nutrition and  proper sanitation (Walsh, 1979). Due to poor sanitation and unhygienic environment  microorganisms can grow favorably. Infectious diseases are therefore the most prevalent diseases  here (Chowdhury, 1995; Das, 1994). Among the infectious diseases, bacterial infections contribute  to most of the mortality specially among the young children (Riley et al., 1983). It has been  reported that in every year, 5 million children die from infectious diseases (WHO, 1997). In order  to combat the bacterial infections, antibacterials are used. In most of the cases, the physicians start  antibiotic therapy with penicillin group, for example ampicillin and amoxicillin. Amoxicillin is  available in liquid form such as dry syrups or powder for suspension. Amoxicillin dry syrup, a  paediatric preparation, ranks the first position in the antibiotic therapeutic class in Bangladesh.  Approximately 35.1% of the prescriptions were found to contain amoxicillin dry syrups (Islam,  1998). Antibiotic resistance has now-a-days become a global health problem (Kunin, 1983). One  of the causes of microbial resistance includes the use of substandard preparations. The availability  and consumption of antimicrobial agents without prescription facilitates the development of MATERIALS AND METHODS

   Materials

 Collection of samples


  The samples of amoxicillin dry suspension were collected  randomly from the retail medicine shops located at different areas  of Bangladesh.    Bacterial strains

  Six bacterial strains were collected for the analytical  purposes. The pathogenic strains included Streptococcus pyogenes,  Streptococcus viridans, Haemophilus influenzae, Bacillus cereus,  Escherichia coli, Shigella and Klebsiella Sp.    Analytical methods  Potency determination

  Amoxicillin contents in dry syrups were determined by  iodometric titration method described in the United States  Pharmacopoeia (USP, XXIII, NF, XVIII, 1995a).    Moisture content determination

  At first 0.5 gm sample was weighed and then put into a  drying oven for 4 hours at 105C. The bottle was taken out and  weighed again. The difference of the two values gave the amount  of water in the sample. Thus, the percentage of loss on drying  (LOD) was calculated by taking the ratio of weight of water in the  sample and total weight of the wet sample and by multiplying with  100. % LOD gave the measure of the moisture content in the  sample (Rankell AS, et al., 1989).    pH determination

  The pH values of the freshly reconstituted amoxicillin dry  syrups were measured by using a pH meter.

   Determination of sedimentation volume   Sedimentation volume was determined by taking a  definite volume of the reconstituted sample into a graduated  cylinder and then keeping it undisturbed for 7 days. After 7 days,  sedimentation volume (F) was calculated from the ratio of the final  volume (Vf) of the sediment to the original or initial volume (Vi) of  the suspension before settling (Martin A, 1993). Sedimentation  volumes were determined for both freshly reconstituted samples  and also for samples undergone storage tests for two months.  


 Stability testing

  In order to test the stability of reconstituted suspensions,  the samples were kept at three controlled temperatures, namely  room, refrigerated and elevated (40ºC) temperatures for 7 days.  The intact samples were studied after keeping at 30ºC and 40ºC for  two months. All the samples were assayed chemically by the  iodometric method as described in the USP (USP, XXIII, NF  XVIII, 1995b). In each sample, the decline in concentration  appeared to follow the first order reaction. Following the Arrhenius  equation (log K = log A - Ea /2.303 R. 1/T), log K values at 30 and  40°C were plotted against the respective reciprocal values of  absolute temperatures , 1/T, when a straight line was obtained. This  when extrapolated to give log K25, and from that shelf-life (t90) of  each samples were determined.   

Microbiological assay

  In order to mesure the biopotency, agar diffusion method  was followed as per the British Pharmacopeia (BP, 1995).

 





Particle size distribution

Particle size  distribution

Definition 

A set of geometric characteristics that define the state of a divided solid. Expression of the distribution of a material  that has been fragmented between the different particle size categories of which it is composed. Particle size distribution is the measurement of the size of the granulates contained in a batch of material and  their distribution in relation to size. Sieving is a particle size distribution method.




The behavior of water in the ground is influenced by the type of soil present.  Soils are classified according to their particle size as follows





There are several different systems in place that denote the particle sizes.  The values given above pertain to the USDA Soil Taxonomy system.  You probably have a good idea of what gravel and sand particles look like, but maybe not silt or clay.  Silt particles are about as big as the thickness of your hair, and clay particles are much smaller than that!
Generally, soils consist of a mixture of different particle types, such as "sandy clay", or a "silty sand".


The Particle size 

conundrum Imagine that I give you a matchbox and a ruler and ask you to tell me the size of it. You may reply saying that the matchbox is 20 x 10 x 5mm. You cannot correctly say "the matchbox is 20mm" as this is only one aspect of its size. So it is not possible for you to describe the 3-dimensional  matchbox with one unique number. Obviously the situation is more  difficult for a complex shape like a grain of sand or a pigment particle in a can of paint. If I am a Q.A. Manager, I will want one number only to describe my particles - I will need to know if the average size has increased or decreased since the last production run, for example. This is the basic problem of particle size analysis - how do we describe a  3-dimensional object with one  number only?  Figure 1 shows some grains of sand. What size are they?