Preformulation studies for sterile dosage forms as per US regulatory body

Submitted by balakrishnatanikonda on Wed, 02/10/2010 - 01:29

Preformulation involves the application of biopharmaceutical principles to the physicochemical parameters of drug substance are characterized with the goal of designing optimum drug delivery system . Preformulation commences when newly synthesized drug shows sufficient pharmacologic promise in animal model to warrant evaluate in manPreformulation is a learning phase about a drug

Preformulation studies have a significant part to play in anticipating formulation problems. The main goal of preformulation studies is Innovative, stable, safe,cost- effective dosage forms capable of delivering the substance for its intended use.

Key words : preformulation, biopharmaceutical., drug delivery.

Author link: http://www.pharmainfo.net/balakrishnatanikonda

Co author : http://www.pharmainfo.net/sathishkumar

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Comments

krishnamohan.ch's picture

krishnamohan.ch

Sun, 02/14/2010 - 05:24

at what stage preformulation studies are carried out?
balakrishnatanikonda's picture

balakrishnatanikonda

Wed, 02/24/2010 - 10:26

in early stages of drug research and development..
Balu
krishnamohan.ch's picture

krishnamohan.ch

Sun, 02/14/2010 - 05:25

can you provide me exact link for the reference in ICH site?
yedla pradeep kumar's picture

yedla pradeep kumar

Tue, 02/16/2010 - 01:22

The exact link for ICH is www.ich.org
Pradeep Kumar
prasadkk's picture

prasadkk

Sun, 02/14/2010 - 20:58

Is any basic differences are there between various guidelines(U.S, E.u, Indian) regarding the Preformulation sterile dosage forms.
sandeepk's picture

sandeepk

Mon, 02/15/2010 - 14:46

can you please list out the formulation problems in sterile dosage forms mnufacture and how can we overcome them using pre formulation studies..?
yedla pradeep kumar's picture

yedla pradeep kumar

Tue, 02/16/2010 - 01:21

What do FDA-CDER & ANDA stand for? Is the link www.ich.gov.in correct?I think its not.
Pradeep Kumar
balakrishnatanikonda's picture

balakrishnatanikonda

Sat, 01/21/2012 - 09:53

food drug administration, centre for drug education and research and abbreviated new drug application.
Balu
kiranmaipenmetsa's picture

kiranmaipenmetsa

Wed, 02/17/2010 - 10:30

good work. may I know the analytiacal methods used to evaluate the drug-excipient interactions of sterile dosage forms?

kiranmaipenmetsa

balakrishnatanikonda's picture

balakrishnatanikonda

Sat, 01/21/2012 - 09:51

DSC, HPLC and FTIR.
Balu
divyadudipalla's picture

divyadudipalla

Wed, 02/17/2010 - 15:52

What about preformulation challenges with poorly soluble compound.

Divya Dudipalla

balakrishnatanikonda's picture

balakrishnatanikonda

Sat, 01/21/2012 - 09:50

solvent costs..
Balu
anushavasireddy's picture

anushavasireddy

Thu, 02/18/2010 - 12:09

1)what is meant by ANDA submission? 2)what do you mean by martindale and merk index? can you give some details about them?

dotty

Fri, 02/19/2010 - 15:44

Dear Author , When you provide answers.we request you to provide answers in your ownwords (do not copy paste from the reference) quoting the reference .

vvummaneni's picture

vvummaneni

Fri, 02/19/2010 - 15:57

how organoleptic properties and chemical structure will help in formulating parenteral dosage forms?

Vishnu Murthy Vummaneni

viswanadh16's picture

viswanadh16

Tue, 03/09/2010 - 13:11

hai balakrsishna, what is Active evaluation in stage 3. can u please tell me what is ICH and DMF
GOPAL

aravikumar

Tue, 03/09/2010 - 14:07

What are the new Clinal trials in sterile dosage forms relating and lack of deficiency in the regulatory body in hospital health care systems in abroad compared.

Averineni Ravi Kumar

anil kumar appa...

Wed, 03/10/2010 - 15:39

what are the extra parameters that sholud consider in preformulation studies of Sterile when compared with Non-sterile dosage forms?

anilkumar

anusha gottipati's picture

anusha gottipati

Sat, 03/13/2010 - 10:13

Please name some of the critical steps prepared by the protocol in sampling and testing the parameters specified?
G.Anusha
anusha gottipati's picture

anusha gottipati

Mon, 03/15/2010 - 00:14

Are there clinical situations where a dosing adjustment should be made with heparin manufactured under the new USP monograph?
G.Anusha
bhavya's picture

bhavya

Mon, 03/22/2010 - 08:12

what are different methods used for compatibility studies, how can we analyse the results obtained from the method whether it has compatibility or not
k.bhavya
bindu's picture

bindu

Thu, 03/25/2010 - 06:51

in slide no.10,you had given the in-house method in testing of active material sample..can you explain me about this method?
maddalalavanya's picture

maddalalavanya

Thu, 03/25/2010 - 08:34

how can we evaluate stability of powders
M.lavanya
balakrishnatanikonda's picture

balakrishnatanikonda

Sat, 01/21/2012 - 09:45

Refer ICH guidelines for the long term and short term stability studies.
Balu
bhanunagendla's picture

bhanunagendla

Fri, 03/26/2010 - 07:18

what are the modern analytical techniques employed in this prefomulation studies?
N.bhanu
balakrishnatanikonda's picture

balakrishnatanikonda

Sat, 01/21/2012 - 09:43

FTIR, HPLC, DSC etc..
Balu
bhanunagendla's picture

bhanunagendla

Sat, 03/27/2010 - 05:29

how do you conduct stability studies for sterile dosage forms?
N.bhanu
balakrishnatanikonda's picture

balakrishnatanikonda

Sat, 01/21/2012 - 09:40

according to ICH guidelines sterile dosage forms have to kept under storage conditions for the longtime and short time stability studies.
Balu
balakrishnatanikonda's picture

balakrishnatanikonda

Sat, 01/21/2012 - 09:40

according to ICH guidelines sterile dosage forms have to kept under storage conditions for the longtime and short time stability studies.
Balu