Navigation Links
Genesis of SUPAC

Scale-UP and Post Approval Changes (SUPAC) is an integral part of pharmaceutical product development but till a few years ago, no guidance was available, to assure a smooth scale-up operation. US FDA was the first regulatory body to address this issue. //

Any pharmaceutical product developed by R&D team has to undergo various stages of scale-up from ‘laboratory-scale’ to ‘pilot-scale’ to ‘production-scale’ before it reaches the market. Scale-up process is an inherent part of overall product development activity and by virtue of variables involved poses a challenge to the product stability and performance. This makes scale-up a very critical component, which if not handled sensitively can undo all the R&D efforts.

Russo, in 1984 discussed the factors influencing the scale up process of various dosage forms. Factors such as variability of raw material, equipment differences, wet granulation effects, and compression press differences have been analysed for their role in scale-up process. The difficulties observed during scale-up of liquid formulations (sterilisation process) and for suppositories, which are quite dependent upon suppository making machines were also enumerated.

Pondell, in 1985 analysed the process variables involved in the film coating operation. Importance of factors like variation in supply of raw material and their response to processing and variation in instrumentation type. Problems crop up during scale up because at R&D scale the product is developed using fairly standard equipment and under controlled conditions compared to production level. The ultimate success of a product, to a great extent is determined by how easily and cost-effectively it can be commercialised.

'"/>




Page: 1

Related medicine news :

1. Acupuncture May Help Chemotherapy Side Effects
2. Antioxidants protect health tissue in people undergoing radiation therapy.
3. Distraction therapy found very effective in postoperative patients
4. Acupuncture superseeds massage therapy for short term relief of pain
5. Ovarian cancer in relationship with Hormone therapy
6. New therapy better at increasing bone density
7. Gene therapy - Aim to improve blood flow
8. Heat therapy relieves back pain
9. Radiotherapy helps in colon cancer
10. New therapy for pimples
11. Support therapy helps breast cancer patients
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:4/28/2017)... ... April 28, 2017 , ... Children ... to more adverse experiences than children in the general population. That’s because foster ... neglect or other family challenges. While no fault of their own, youth who ...
(Date:4/28/2017)... ... 28, 2017 , ... Bill Howe started his sewer and drain company in ... Howe joined the team, the Bill Howe brand was born and they began cultivating ... giving back to the San Diego community in which they worked, lived and were ...
(Date:4/28/2017)... New York, New York (PRWEB) , ... April ... ... of high-quality anti-aging skincare and advanced nutraceutical supplements, through its Nova ... fast-absorbing cream provides the hydrating benefits of a moisturizer with the power of ...
(Date:4/27/2017)... PHILADELPHIA and DENVER (PRWEB) , ... April 27, ... ... Jewish Health, the nation’s leading respiratory hospital, based in Denver, Colorado, announced an ... Institute is enabled by the continuing support of the Jane and Leonard Korman ...
(Date:4/27/2017)... ... April 27, 2017 , ... Last night, Christine Collins ... the Year for her extraordinary compassion and lifelong dedication to serve others. Since ... caregivers for the prestigious award each year – identifying a CAREGiver who has ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... YORK , April 19, 2017 The Mobile ... to showcase a healthy CAGR during the forecast period ... type in the global digital mobile X-Ray devices market, which ... Mn in 2017, expanding at a CAGR of 7% over ... absolute $ opportunity of more than US$ 100 Mn in ...
(Date:4/19/2017)... PUNE, India , April 19, 2017 ... Type and Application, Forecast to 2022 report has covered and ... provides statistics and information on market size, shares and growth ... with major drivers, challenges and opportunities in the global market. ... Browse 152 Tables and ...
(Date:4/19/2017)... THOUSAND OAKS, Calif. , April 19, 2017 ... premium industrial buildings it is developing at Conejo ... California , to Atara Biotherapeutics, Inc. ... patients with severe and life-threatening diseases that have ... focus on allogeneic T-cell therapies for cancer, autoimmune ...
Breaking Medicine Technology: