Author(s): Saloni Sharma, Amit B. Patil, DV Gowda

Email(s): salpalrockzz@gmail.com , amitbpatil@jssuni.edu.in , dvgowda@jssuni.edu.in

DOI: 10.5958/0974-360X.2020.00872.0   

Address: Saloni Sharma*, Amit B. Patil, DV Gowda
Department of Industrial Pharmacy, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka – 560078, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 10,     Year - 2020


ABSTRACT:
The manufacture of oral dosage forms is a complex process in which the starting material of API is converted into the final product by the manufacturing and processing into different physical properties in order to produce the final product. The initial step for tabletting is the process of granulation under which is the dry and wet granulation. Following the process parameters of bioavailability and stability of the product it is related to the content uniformity. The next step is the powder blending property which is supported by the pre and post blending processes in the manufacturing process itself. The process parameters used here are mixing time and blending speed. All the initial steps should be evaluated at the manufacturing and the beginning stage itself. The quality and quantity of the lubricant used plays an important role in the quality of the final product. Furthermore, is the step of drying to irradiate the moisture content in the product, hence increases the free flowing properties of the product powdered particles. The final step of the tabletting process tablet compression. There should be no impressions present in and around the tablet for a good stabilised final product.


Cite this article:
Saloni Sharma, Amit B. Patil, DV Gowda. Pilot Plant Scale up for Tablet. Research J. Pharm. and Tech. 2020; 13(10):4973-4980. doi: 10.5958/0974-360X.2020.00872.0


REFERENCES:
1.    Furlanetto S, Cirri M, Maestrelli F, Corti G, Mura P. Study of formulation variables influencing the drug release rate from matrix tablets by experimental design. Eur J Pharm Biopharm. 2006;62(1):77–84.
2.    Dalziel G, Nauka E, Zhang F, Kothari S, Xie M. Assessment of granulation technologies for an API with poor physical properties. Drug Dev Ind Pharm. 2013;39(7):985–995.
3.    Repka MA, Mc Ginity JW. Physical–mechanical, moisture absorption and bioadhesive properties of hydroxy propyl cellulose hot- melt extruded films. Biomaterials. 2000;21(14):1509–1517.
4.    Ahmed M. Acute toxicity (Lethal Dose 50 Calculation) of herbal drug Somina in rats and mice. Pharmacol Pharm. 2015;6(03):185.
5.    Sreenivas SA, Dandagi PM, Gadad AP, Godbole AM, Hiremath SP, Mastiholimath VS, et al. Orodispersible tablets: New- fangled drug delivery system-A review. Indian J Pharm Educ. 2005; 39(4):177.
6.    Crommelin DJ, Storm G, Verrijk R, de Leede L, Jiskoot W, Hennink WE. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm. 2003;266(1–2):3–16.
7.    Spiegel R. Pharma Industry Sees Process Innovation at Last. February; 2006.
8.    Willkommen H. Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes. PDA J Pharm Sci Technol. 2014;68(1):66–82.
9.    Florence AT, Siepmann J. Modern Pharmaceutics, Volume 2: Applications and Advances. CRC Press; 2016.
10.    Billings SW, Bronlund JE, Paterson AHJ. Effects of capillary condensation on the caking of bulk sucrose. J Food Eng. 2006;77(4):887–895.
11.    Nyström C, Alderborn Gör, Duberg M, Karehill P-G. Bonding surface area and bonding mechanism-two important factors fir the understanding of powder comparability. Drug Dev Ind Pharm. 1993;19(17–18):2143–2196.
12.    Huang S-M, Strong JM, Zhang L, Reynolds KS, Nallani S, Temple R, et al. New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process. J Clin Pharmacol. 2008;48(6): 662–670.
13.    Whitmire M, Ammerman J, De Lisio P, Killmer J, Kyle D, Mainstone E, et al. LC-MS/MS bioanalysis method development, validation, and sample analysis: points to consider when conducting nonclinical and clinical studies in accordance with current regulatory guidance’s. J Anal Bioanal Tech S. 2011;4(2).
14.    Beal SL. Ways to fit a PK model with some data below the quantification limit. J Pharmaco kinet Pharmacodyn. 2001; 28(5):481– 504.
15.    Bhadra D, Bhadra S, Jain P, Jain NK. Pegnology: a review of PEG-ylated systems. Pharm. 2002;57(1):5–29.
16.    Schellekens H. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther. 2002;24(11):1720– 1740.
17.    Thanou M, Verhoef JC, Junginger HE. Chitosan and its derivatives as intestinal absorption enhancers. Adv Drug Deliv Rev. 2001;50:S91–S101.
18.    Alpar HO, Somavarapu S, Atuah KN, Bramwell VW. Biodegradable mucoadhesive particulates for nasal and pulmonary antigen and DNA delivery. Adv Drug Deliv Rev. 2005;57(3):411–430.
19.    Hussain A, Arnold JJ, Khan MA, Ahsan F. Absorption enhancers in pulmonary protein delivery. J Controlled Release. 2004; 94(1):15–24.
20.    Neena Washington CW, Wils C. Physiological Pharmaceutics: Barriers to Drug Absorption. CRC Press, Taylor and Francis group; 2001.
21.    Tang L, Persky AM, Hochhaus G, Meibohm B. Pharmacokinetic aspects of biotechnology products. J Pharm Sci. 2004;93(9):2184–2204.
22.    Bottle RT, Rowland JFB. Information sources in chemistry. Walter de Gruyter; 2011.
23.    FDA U. Guideline on general principles of process validation. Guide Indus May. 1987;
24.    Lebson L, Nash K, Kamath S, Herber D, Carty N, Lee DC, et al. Trafficking CD11b-positive blood cells deliver therapeutic genes to the brain of amyloid-depositing transgenic mice. J Neurosci. 2010; 30(29):9651–9658.
25.    Randall CW. PAT Pending Technology Tools for Developing Improved Pharmaceutical Manufacturing Processes. Adv Manuf Summit West Lafayette. 2004;7(12).
26.    Alvarez-Lorenzo C, Gomez-Amoza JL, Martinez-Pacheco R, Souto C, Concheiro A. The stability of theophylline tablets with a hydroxy propyl cellulose matrix. Drug Dev Ind Pharm. 2000;26(1):13–20.
27.    Benita _S, Levy MY. Submicron emulsions as colloidal drug carriers for intravenous administration: comprehensive physicochemical characterization. J Pharm Sci. 1993; 82(11): 1069–1079.
28.    Korner D, Benita S, Albrecht G, Baszkin A. Surface properties of mixed phospholipid—stearylamine monolayers and their interaction with a non-ionic surfactant (poloxamer). Colloids Surf B Biointerfaces. 1994;3(1–2):101–109.
29.    Melamed S, Kurtz S, Greenbaum A, HOWES J, Neumann R, Garty N. Adaprolol maleate in submicron emulsion-a novel soft b-blocking agent, is safe and effective in human studies. In: investigative ophthalmology and visual science. Lippincott-Raven Publ 227 East Washington sq, Philadelphia, pa 19106; 1994. p. 1387–1387.
30.    Al-Hamidi H, Edwards AA, Mohammad MA, Nokhodchi A. To enhance dissolution rate of poorly water-soluble drugs: glucosamine hydrochloride as a potential carrier in solid dispersion formulations. Colloids Surf B Biointerfaces. 2010;76(1):170–178.
31.    Miura H, Kanebako M, Shirai H, Nakao H, Inagi T, Terada K. Enhancement of dissolution rate and oral absorption of a poorly water-soluble drug, K-832, by adsorption onto porous silica using supercritical carbon dioxide. Eur J Pharm Biopharm. 2010;76(2):215– 221.
32.    Al-Hamidi H, Edwards AA, Mohammad MA, Nokhodchi A. Erratum to To enhance dissolution rate of poorly water-soluble drugs: glucosamine hydrochloride as a potential carrier in solid dispersion formulations [Colloids Surf. B: Biointerf.,(2010), 76, 170-178]. Colloids Surf B Biointerfaces. 2010;79(2):535.
33.    Aiache JM, Meski SE, Beyssac E, Serpin G. The formulation of drug for ocular administration. J Biomater Appl. 1997;11(3):329–348.
34.    Mang T, Dresel W, Wiley J. Lubricants and lubrication. Vol. 2. Wiley-Vch Weinheim, Germany; 2007.
35.    Rosen MJ, Kunjappu JT. Surfactants and interfacial phenomena. John Wiley and Sons; 2012.
36.    Vinot B, Schechter RS, Lake LW. Formation of water-soluble silicate gels by the hydrolysis of a diester of dicarboxylic acid solublized as microemulsions. SPE Reserv Eng. 1989;4(03):391–397.
37.    Aïtcin P-C. Binders for durable and sustainable concrete. CRC Press; 2007.
38.    Mozda RF. Medicament adsorbates and their preparation. 1988.
39.    Lim S-J, Kim C-K. Formulation parameters determining the physicochemical characteristics of solid lipid nanoparticles loaded with all-trans retinoic acid. Int J Pharm. 2002;243(1–2):135–146.
40.    Lim S-J, Lee M-K, Kim C-K. Solid Lipid Nanoparticle Formulation of All Trans Retinoic Acid. J Pharm Investig. 2001;31(3):167–172.
41.    Schwarz C, Mehnert W. Freeze-drying of drug-free and drug-loaded solid lipid nanoparticles (SLN). Int J Pharm. 1997;157(2):171–179.
42.    Agnihotri SA, Jawalkar SS, Aminabhavi TM. Controlled release of cephalexin through gellan gum beads: Effect of formulation parameters on entrapment efficiency, size, and drug release. Eur J Pharm Biopharm. 2006;63(3):249–261.
43.    El Hagrasy AS, Hennenkamp JR, Burke MD, Cartwright JJ, Litster JD. Twin screw wet granulation: influence of formulation parameters on granule properties and growth behavior. Powder Technol. 2013;238:108–115.
44.    Mao S, Shi Y, Li L, Xu J, Schaper A, Kissel T. Effects of process and formulation parameters on characteristics and internal morphology of poly (d, l-lactide-co-glycolide) microspheres formed by the solvent evaporation method. Eur J Pharm Biopharm. 2008;68(2):214–223.
45.    Gay Moldenhauer M, Graham Nairn J. Formulation parameters affecting the preparation and properties of microencapsulated ion-exchange resins containing theophylline. J Pharm Sci. 1990;79(8):659–666.
46.    Singh M, Chitranshi N, Singh AP, Arora V, Siddiqi AW. An overview on fast disintegrating sublingual tablets. Int J Drug Deliv. 2012;4(4):407.
47.    Prashar D, Kumar S, Chauhan A, Purohit R. Pharmaceutical and Economical Aspects of Porous Tablets. Res J Pharm Dos Forms Technol. 2012;4(1):19–23.
48.    Taylor AS, Stratford PW, Yianni YP, Woodroffe MJ, Rowan L. Biocompatible crosslinked coating and crosslinkable coating polymer composition for forming such a coating. 2009.
49.    Krebs FC. Fabrication and processing of polymer solar cells: a review of printing and coating techniques. Sol Energy Mater Sol Cells. 2009;93(4):394–412.
50.    Sahatjian R. Drug delivery system making use of a hydrogel polymer coating. 1994.
51.    Markle RA, Brusky PL, Baker JH. Process for coating polymer surfaces and coated products produced using such process. 1990.
52.    Rypacek F, Lapcikova M, Machova L. Polymer coating for medical devices. 2007.
53.    Entwistle CA, Rowe RC. Plasticization of cellulose ethers used in the film coating of tablets. J Pharm Pharmacol. 1979;31(1):269–272.
54.    Yang QW, Flament MP, Siepmann F, Busignies V, Leclerc B, Herry C, et al. Curing of aqueous polymeric film coatings: importance of the coating level and type of plasticizer. Eur J Pharm Biopharm. 2010;74(2):362–370.
55.    Wheatley TA, Bridges Jr CI, Steuernagel CR. Film-forming composition and use for coating pharmaceuticals, foods and the like. 1993.
56.    Wilson KE, Crossman E. The influence of tablet shape and pan speed on intra-tablet film coating uniformity. Drug Dev Ind Pharm. 1997;23(12):1239–1243.
57.    Syukri Y, Fernenda L, Utami FR, Qiftayati I, Kusuma AP, Istikaharah R. Preperation And Characterization Of B-Cyclodextrin Inclusion Complexes Oral Tablets Containing Poorly Water Soluble Glimipiride Using Freeze Drying Method. Indones J Pharm. 2015;26(2):71.
58.    Jeevanandham S, Dhachinamoorthi D, Senthil V, Sekhar KC. Fabrication and evaluation of oral tablets using natural mucoadhesive agent from seeds of Caesalpinia pulcherrima (L.) SW. Asian J Pharm AJP Free Full Text Artic Asian J Pharm. 2014;4(2).
59.    Kumar L, Singh V, Meel RK. Formulation development and evaluation of oral disintegrating tablet of candesartan cilexetil. 2014;
60.    Behzadi SS, Toegel S, Viernstein H. Innovations in coating technology. Recent Pat Drug Deliv Formul. 2008; 2(3):209–230.
61.    Otles S, Lecoq O, Dodds JA. Dry particle high coating of biopowders: An energy approach. Powder Technol. 2011; 208(2): 378– 382.
62.    Stiel DM. Method invoking tabletting compression force control for optimizing tabletted formulation parameters. 1978.

Recomonded Articles:

Author(s): Ravindranath S. Misal, Vishawas R. Potphode, Vijay R. Mahajan

DOI: 10.5958/0974-360X.2017.00218.9         Access: Open Access Read More

Author(s): Niharika, Navneet Verma

DOI: 10.5958/0974-360X.2016.00182.7         Access: Open Access Read More

Author(s): Rakhi Mehra, Renu Makhija, Neera Vyas

DOI: Not Available         Access: Open Access Read More

Author(s): Jino Elsa Thomas, Usha Y Nayak*, Jagadish PC, Koteshwara KB

DOI: 10.5958/0974-360X.2017.00007.5         Access: Open Access Read More

Author(s): Sonte Sushmitha, Sedimbi Revathi Priyanka, L. Mohan Krishna, M. Srinavasa Murthy

DOI: Not Available         Access: Open Access Read More

Author(s): Deepak Karki, Gururaj S. Kulkarni, Shivakumar Swamy, Sheeba FR

DOI: 10.5958/0974-360X.2017.00750.8         Access: Open Access Read More

Author(s): Mistry Khushboo, Kavya Naik, Vasanthi, Alicia Menezes, Anup Naha, K.B. Koteshwara, K. Girish Pai

DOI: 10.5958/0974-360X.2017.00540.6         Access: Open Access Read More

Author(s): Mayanka Singh, Manoj Charde, Rajesh Shukla, Rita M. Charde

DOI: Not Available         Access: Open Access Read More

Author(s): Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya

DOI:         Access: Open Access Read More

Author(s): S.M. Charjan, S.K. Bais, R.R. Shiradkar, R.L. Bakal, V.M. Durge, A.V. Chandewar

DOI: Not Available         Access: Open Access Read More

Author(s): Vaseeha Banu T.S., Sandhya K.V., K.N. Jayaveera

DOI: Not Available         Access: Open Access Read More

Author(s): Ravi K. Barde, Minal R. Narkhede, V.R. Gudsoorkar, Rahul K. Amrutkar, Prashant S. Walke

DOI: Not Available         Access: Open Access Read More

Author(s): Rekha Kallam, Padma Sree K, Srinivas Arutla, MA Bari

DOI: Not Available         Access: Open Access Read More

Author(s): Mohd Yousuf Ali, Md Shamim Qureshi, Md Hamed, Byasabhusan Das and K Purushotham Rao

DOI: Not Available         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags