Saturday, March 23, 2013

Free Download of FASTtrack Physical Pharmacy pdf e-book. Edited By Alexander T. Florence & David Attwood.

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Free Download of TEXTBOOK OF MEDICAL PHYSIOLOGY pdf e-book (11th Edition). Edited By GUYTON & HALL


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Free Download of Ganong`s Review Of Medical Physiology pdf e-book (23rd Edition).


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Free Download of Human anatomy pdf e-book. Edited By VAN DE GRAAFF.

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Free Download of Essential Medical Physiology pdf e-book (Third Edition). Edited By Leonard R. Johnson.


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Friday, March 22, 2013

Fumigation Method for Pest Control Used in Aseptic Area

Fumigation:

Fumigation is a method of pest control that completely fills an area with gaseous pesticides or fumigants to suffocate or poison the pests within. It is utilized for control of pests.

Process:
Fumigation usually involves the following phases: First the area to be fumigated is cleaned and disinfected as per SOP Clean up of Aseptic Area. Next the fumigant (40 % formaldehyde solution is widely used as fumigant) is released (create fume by heating the solution with a heater) into the space to be fumigated. After completely evaporation of  formaldehyde solution the space is held for a set period (eg. 6 hours) while the fumigant gas percolates through the space and acts on and kills any infestation in the product, next the space is ventilated so that the poisonous gases are allowed to escape from the space, and render it safe for humans to enter.

Preparation of Fumigation Solution:
Prescription:  Use formaldehyde at the rate of 2.5-mg/ liter volume space. [1litre º 0.03531466 cft]
                                
Take the required quantity of 40 % formalin according to the prescription and add 25 % distilled water to make the stock solution.

Calculation:
40 % commercial formalin i.e., 100ml contains 40gm of formaldehyde.
According to prescription 1 litre or 0.03531466 cft require 2.5 mg of formaldehyde.
                                               
                                                2.5
    1 cft require    =                                         mg of Formaldehyde
                                          0.03531466

                                            2.5 x V
    V cft require  =                                          mg of Formaldehyde  
                             0.03531466        (Where V = Volume of space to be fumigated).                    
                          
                              = 70.792V mg     = 0.070792V   gm

        40 gm Formaldehyde from 100ml Commercial formalin

                                                  100
     1 gm           ,,                       ,,                    ml  Commercial formalin
                                                   40           
                                                   
                                                100 x 0.070792V
 0.070792V gm  ,,            ,,                                     ml Commercial formalin
                                                           40
                                                 
                                                           = 0.17698 V ml commercial formalin 


Widely used fumigants include:

Parameters and Specification of Dissolution & Disintegration of Tablets


Tablets (Disintegration & Dissolution)
  
 Tablets are solid preparations each containing a single dose of one or more active  substances. They are obtained by compressing uniform volumes of particles or by  another suitable manufacturing technique, such as extrusion, moulding or freeze- drying (lyophilisation). Tablets are intended for oral administration. Some are  swallowed whole, some after being chewed, some are dissolved or dispersed in  water before being administered and some are retained in the mouth where the active  substance is liberated.
 
 The particles consist of one or more active substances with or without excipients  such as diluents, binders, disintegrating agents, glidants, lubricants, substances  capable of modifying the behaviour of the preparation in the digestive tract, colouring  matter authorised by the competent authority and flavouring substances.

Several categories of tablets for oral use may be distinguished:
·           uncoated tablets;
·           coated tablets;
·               effervescent tablets;
·           soluble tablets;
·           dispersible tablets;
·           orodispersible tablets;
·           gastro-resistant tablets;
·           modified-release tablets;
·           tablets for use in the mouth;
·               oral lyophilisates.


Disintegration:

Type of Tablet
Media
Specification

For Out of Specification

UNCOATED TABLETS


Water (37°C ± 2°C)
Not More Than 15 minutes with disc

Repeat the test on a further 6 Tablets

Film-coated Tablets


Water (37°C ± 2°C)
Not More Than 30 minutes with disc


Repeat the test on a further 6 Tablets

Enteric Coated Tablets

0.1 M hydrochloric acid without disc (37°C ± 2°C)
(after 2 hours replace 0.1 M HCl Solution with the phosphate buffer)
2 hours remains intake

Repeat the test on a further 6 Tablets

phosphate buffer  solution pH 6.8   (with disc)         (37°C ± 2°C)
Not More Than 60 minutes with disc
Effervescent Tablet
200 ml Water (15-25 °C)
Not More Than 5 minutes
Repeat the test on a further 5 Tablets

Soluble Tablet
Water (15-25 °C)
Not More Than 3 minutes
Repeat the test on a further 6 Tablets

Dispersible Tablets
Water (15-25 °C)
Not More Than 3 minutes
-------
Orodispersible Tablets
------
Not More Than 3 minutes
------

Dissolution:
Four types of apparatuses are now described in the British and European Pharmacopoeias; the basket, the paddle, the reciprocating cylinder and the flow-through cell. The descriptions are concordant with those published in the United States Pharmacopeia (USP).  
 
 Of the two established apparatuses (basket and paddle) the paddle is now the apparatus of choice for many preparations. However, where a published test uses the basket, work to validate a change to the paddle method is not contemplated. The reciprocating cylinder is useful for pH profiling studies while the flow-through cell may be appropriate for preparations of poorly soluble active ingredients (see Annex).
  
Test conditions The harmonised test conditions included in Appendix XII B1 will be applied to all new monographs of the British Pharmacopoeia. It is not the intention of the British Pharmacopoeia Commission to apply these criteria retrospectively to existing monographs. Where an individual monograph prescribes the use of the requirements stated under Monographs of the British Pharmacopoeia in Appendix XII B1, the following conditions using the basket or paddle apparatus are preferred.
 
Ø  rotation speed:100 rpm (basket), 50 rpm (paddle)
Ø  dissolution medium volume: 900 ml  
Ø  dissolution medium composition: aqueous, commonly 0.1M hydrochloric acid  or phosphate buffers of pH 6.8 to 7.6
Ø  number of units tested: 6 (plus 6, if a retest is required).
 
 The number of units tested is specified in Appendix XII B1; other conditions are specified in the relevant individual monographs.
 
 In situations where it has been demonstrated that the harmonised criteria are not applicable (e.g. low solubility preparations, 'coning' of material in the vessel, low concentration of analyte), modifications may be made to the test conditions, such as, adding a surfactant, increasing the paddle rotation speed or using a modified vessel and reducing the volume of dissolution medium used.


    
 
Dissolution:

Type of Tablet
Media
Specification

For Out of Specification
UNCOATED TABLETS

0.1 M hydrochloric acid  / phosphate buffer  solution / Water (37°C ± 0.5°C)
Should not be released less than 70% of labeled amount at 45 minutes
Repeat the test on a further 6 Tablets

Film-coated Tablets

0.1 M hydrochloric acid  / phosphate buffer  solution / Water(37°C ± 0.5°C)
Should not be released less than 70% of labeled amount at 45 minutes

Repeat the test on a further 6 Tablets

Enteric Coated Tablets




(media for 2 hours)
0.1 M hydrochloric acid (37°C ± 0.5°C)
Should not be released more than 10% of labeled amount after 2 hours

Repeat the test on a further 6 Tablets
Then replace the 0.1 M HCl by phosphate buffer  solution pH 6.8  (37°C ± 0.5°C)
Should not be released less than 70% of labeled amount at 45 minutes




                                     
















Source: BP 2013 

Thursday, March 21, 2013

Free Download of Nanoparticulates as Drug Carriers pdf e-book. Edited By Vladimir P Torchilin.

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Free Download of Methods of Analysis For Functional Foods and Nutraceuticals pdf e-book. Edited By W. Jeffrey Hurst.

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Free Download of Managing The Analytical Laboratory pdf e-book. Edited By Clifford L. Nilsen.

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Free Download of Liposome Technology Entrapment of Drugs and Other Materials Into Liposomes (Third Edition) pdf e-book. Edited By Gregory Gregoriadis.

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Free Download of Hospital Pre-registration Handbook

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Free Download of Good Manufacturing Practices For Pharmaceuticals (Sixth Edition) pdf e-book. Edited By Josheph D. Nally. To Download this e-book click on the following image or link:

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Free Download of Handbook of Aqueous Solubility Data pdf e-book. Edited By Samuel H. Yalkowsky & Yan He.

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Monday, March 18, 2013

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Sunday, March 17, 2013

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