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Nagabhushanam, M. V.
- formulation Studies on Solid Dispersions of Mefenamic Acid in Superdisintegrants
Abstract Views :160 |
PDF Views:80
Authors
Affiliations
1 Dept of Pharmaceutics, D.C.R.M.Pharmacy College, Inkollu, Prakasam District, (A.P.), Pin - 523 167, IN
1 Dept of Pharmaceutics, D.C.R.M.Pharmacy College, Inkollu, Prakasam District, (A.P.), Pin - 523 167, IN
Source
Journal of Pharmaceutical Research, Vol 8, No 3 (2009), Pagination: 162-166Abstract
The feasibility of formulating the solid dispersions of mefenamic acid into tablet dosage forms is evaluated. All the tablets formulated employing solid dispersions of mefenamic acid in superdisintegrants gave rapid and higher dissolution of mefenamic acid when compared to that of mefenamic acid plain tablets. The increasing order of dissolution rate of formulated tablets with various carriers was Croscarmellose (CC)>Pregelatinised starch (PGS) > Primojel(PJ) > Crospovidone (CP). The same order of performance was observed with tablets formulated employing superdisintegrants alone and in combination with PVP.A 2.75 fold increase in the dissolution rate of mefenamic acid was observed with tablets formulated employing its solid dispersions in CC (MAF4) when compared to plain tablets (MAF1). A 6.97 fold increase in the dissolution rate of mefenamic acid was observed with tablets formulated employing its solid dispersions in combined carriers CC and PVP (MAF8) when compared to its plain tablets (MAF1).Keywords
Mefenamic Acid, Solid Dispersion, Dissolution Rate, Solubility, Polyvinylpyrrolidine, Pregelatinised Starch.Full Text
- In Vitro Dissolution Enhancement Studies on Binary Solid Dispersions of Lornoxicam
Abstract Views :211 |
PDF Views:90
Authors
Affiliations
1 D.C.R.M.Pharmacy College, Inkollu - 523167, Prakasam Dt., Andhra Pradesh, IN
2 Vishwa Bharathi College of Pharmaceutical Sciences, Perecherla-522 009, Guntur Dt., Andhra Pradesh, IN
1 D.C.R.M.Pharmacy College, Inkollu - 523167, Prakasam Dt., Andhra Pradesh, IN
2 Vishwa Bharathi College of Pharmaceutical Sciences, Perecherla-522 009, Guntur Dt., Andhra Pradesh, IN
Source
Journal of Pharmaceutical Research, Vol 11, No 3 (2012), Pagination: 86-91Abstract
The poor solubility and wettability of a non steroidal anti-inflammatory drug, Lornoxicam leads to poor dissolution and hence, low bioavailability after oral administration. The objective of the study was to formulate solid dispersions of Lornoxicam to improve the aqueous solubility and dissolution rate to facilitate faster onset of action. Lornoxicam is a BCS class II drug having low aqueous solubility and therefore low bioavailability. In the present study, solid dispersions of Lornoxicam with three different hydrophilic polymers and one superdisintegrant in 4 drug-carrier ratios were prepared by solvent evaporation and common solvent methods. Solid dispersions were characterized by infrared spectroscopy (IR) and evaluated for drug content, dissolution rate constant, regression coefficient. The dissolution rate and dissolution efficiency of the prepared solid dispersions were evaluated in comparison to the corresponding pure drug. The invitro dissolution studied showed increased drug release rates compared to that of pure API alone. The increasing order of dissolution rate of solid dispersions Lornoxicam with various polymers was HPMC > PVP > PEG. The solid dispersions in combined carriers gave much higher rates of dissolution than superdisintegrants alone. Finally, in-vitro dissolution studies showed that Lornoxicam release was greatly improved by formation of solid dispersion. A 170.2 fold increase in the dissolution rate of Lornoxicam was observed with solid dispersions prepared using combined carriers such as HPMC, MCC whereas only a 15.78 fold increase was observed with solid dispersions prepared using only MCC. Thus, the solid dispersion technique can be successfully used for enhancement of dissolution rate.Keywords
Lornoxicam, Solid Dispersions, Hydrophilic Polymers, Super Disintegrants.Full Text
- Ternary Solid Dispersions of Celecoxib: from Physical Characterization to Dissolution Enhancement
Abstract Views :166 |
PDF Views:66
Authors
Affiliations
1 DCRM Pharmacy College, Inkollu - 523 167, Prakasam (Dt.,) A.P., IN
2 Department of Biotechnology, Acharya Nagarjuna University, Nagarjuna Nagar - 522510, Guntur, A.P., IN
3 Rahul Institute of Pharmaceutical Sciences & Research , Chirala - 523155, Prakasam Dt., A.P., IN
4 Narasaraopeta Institute of Pharmaceutical Sciences, Kotappakonda Road, Yellamanda Post, Narasaraopet - 522601, Guntur Dt., A.P., IN
1 DCRM Pharmacy College, Inkollu - 523 167, Prakasam (Dt.,) A.P., IN
2 Department of Biotechnology, Acharya Nagarjuna University, Nagarjuna Nagar - 522510, Guntur, A.P., IN
3 Rahul Institute of Pharmaceutical Sciences & Research , Chirala - 523155, Prakasam Dt., A.P., IN
4 Narasaraopeta Institute of Pharmaceutical Sciences, Kotappakonda Road, Yellamanda Post, Narasaraopet - 522601, Guntur Dt., A.P., IN
Source
Journal of Pharmaceutical Research, Vol 12, No 2 (2013), Pagination: 80-85Abstract
The poor solubility and wettability of a non steroidal anti inflammatory drug, celecoxib leads to poor dissolution and hence, low bioavailability after oral administration. The objective of the present study was to formulate solid dispersions of celecoxib, with water soluble polymers poly vinyl pyrrolidine (PVP K30), poly ethylene glycol (PEG 6000), hydroxypropyl methylcellulose 5cps (HPMC) and a super disintegrant namely pregelatinised starch (PGS) by common solvent and solvent evaporation methods. Solid Dispersions prepared were evaluated for dissolution rate and dissolution efficiency in comparison to the corresponding pure drug. Solid dispersions of celecoxib showed a marked enhancement in dissolution rate and dissolution efficiency. The increasing order of dissolution rate of solid dispersions of celecoxib with various polymers was HPMC > PVP > PEG. Solid dispersions at 2:2:6 ratio of C: HPMC: PGS, a 53.57 fold increase in the dissolution rate of celecoxib was observed. Solid dispersions were characterized by infrared spectroscopy (IR), differential scanning calorimetry (DSC) and X-ray diffractogram (XRD). Solid dispersions in combined carriers gave much higher rates of dissolution than super disintegrant PGS alone. Super disintegrant PGS alone or in combination with hydrophilic polymers could be used to enhance the dissolution rate of poorly soluble drug celecoxib. Finally, in-vitro dissolution studies showed that celecoxib release was greatly improved by formation of solid dispersion.Keywords
Celecoxib, Solid Dispersions, Dissolution Rate, Solubility, Superdisintegrant.Full Text
- Formulation and Characterization of Solid Lipid Nanoparticles
Abstract Views :199 |
PDF Views:83
Authors
Affiliations
1 D.C.R.M Pharmacy College, Inkollu - 523 167, Prakasam Dt., Andhra Pradesh, IN
2 QIS College of Pharmacy, Ongole - 523 001, Prakasam Dt., Andhra Pradesh, IN
1 D.C.R.M Pharmacy College, Inkollu - 523 167, Prakasam Dt., Andhra Pradesh, IN
2 QIS College of Pharmacy, Ongole - 523 001, Prakasam Dt., Andhra Pradesh, IN
Source
Journal of Pharmaceutical Research, Vol 12, No 4 (2013), Pagination: 128-133Abstract
In view of increasing bioavailability and percentage drug release by lymphatic drug delivery, Fosinopril loaded solid lipid nanoparticles were prepared by solvent emulsification and evaporation method. In vitro drug release studies revealed that 80% of the drug was being released from the optimized Fosinopril loaded solid lipid nanoparticles (SLNs) in 24hours. Optimized formulation and process parameters resulted in the production of Fosinopril loaded solid lipid nanoparticles with average particle size of 178.8 nm, zeta potential of -21mV and entrapment efficiency of 91.64% of 10 mg loading. In vitro characterization was carried out to evaluate the stability and release characteristics and kinetics. To analyze the release kinetics of drug from SLNs, drug release data was fitted into zero order, Korsmeyer-Peppas equation. Possible mechanisms for drug release might be anomalous diffusion or non-fickian diffusion. FTIR spectra, DSC thermograms revealed no significant interaction between drug and excipients. TEM photographs exhibited nanosized particles of Fosinopril. The stability studies performed for optimized SLN formulation at 4°C, 25°C, showed no significant change in % entrapment efficiency for one month. So, it was concluded that the optimized SLN formulation offers an efficient mode of delivery to the lipophilic antihypertensive drug, Fosinopril.Keywords
Fosinopril, Solid Lipid Nanoparticles, Solvent Emulsification and Evaporation, Anti Hypertensive Drug.Full Text
- Employment of Combined Carriers for Dissolution Enhancement of Celecoxib
Abstract Views :210 |
PDF Views:80
Authors
Affiliations
1 DCRM Pharmacy College, Inkollu, Prakasam Dt., Pin : 523 167, Andhra Pradesh, IN
2 Vishwa Bharathi College of Pharmaceuticals, Perecherla, Guntur Dt., Pin : 522 009, A.P., IN
3 Chilukuri Balaji Pharmacy College, Aziz Nagar, Moinabad, Hyderabad, Pin 500 075, A.P., IN
1 DCRM Pharmacy College, Inkollu, Prakasam Dt., Pin : 523 167, Andhra Pradesh, IN
2 Vishwa Bharathi College of Pharmaceuticals, Perecherla, Guntur Dt., Pin : 522 009, A.P., IN
3 Chilukuri Balaji Pharmacy College, Aziz Nagar, Moinabad, Hyderabad, Pin 500 075, A.P., IN
Source
Journal of Pharmaceutical Research, Vol 10, No 4 (2011), Pagination: 166-169Abstract
Solid Dispersions of celecoxib (C) with water soluble polymers polyvinylpyrrolidine (PVP), polyethylene glycol (PEG), hydroxylpropylmethylcellulose (HPMC) and a superdisintegrant namely microcrystalline cellulose (MCC) were prepared by common solvent and solvent evaporation methods employing methanol as solvent. Solid Dispersions prepared were evaluated for dissolution rate and dissolution efficiency in comparison to the corresponding pure drug. Solid dispersions of celecoxib showed a marked enhancement in dissolution rate and dissolution efficiency. Solid dispersions of C:HPMC:MCC at 2:2:10 ratio showed 7.71 fold increase in the dissolution rate of celecoxib. Solid dispersions in combined carriers gave much higher rates of dissolution than MCC alone. MCC alone or in combination with hydrophilic polymers could be used to enhance the dissolution rate of poorly soluble drug celecoxib.Keywords
Celecoxib, Solid Dispersions, Dissolution Rate, Solubility, Superdisintegrant, Hydrophilic Polymer.Full Text
- Drug Master File Filing in US, Europe, Canada and Australia
Abstract Views :222 |
PDF Views:63
Authors
Affiliations
1 Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Amravati Road, Guntur, AP, IN
1 Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Amravati Road, Guntur, AP, IN
Source
Journal of Pharmaceutical Research, Vol 16, No 2 (2017), Pagination: 160-173Abstract
Purpose: A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation, it is submitted solely at the discretion of the DMF holder. The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. The present work gives the Detailed idea on how to file Drug Master File in US, EUROPE, CANADA, AUSTRALIA.
Approach: A Drug Master File is a submission of information to the FDA to permit the FDA to review this information in support of a third party's submission without revealing the information to the third party. In US, DMF filing was done through NDA for drugs, ANDA for generics and BLA for Biologics. In Europe, DMF filing was done through MAA via centralized procedure for eligible products and for other products via decentralized procedure was used. In CANADA, DMF filing was done through NDS for both drugs and biologic products, where as in AUSTRALIA different application processes and regulatory requirements apply depending on the type of therapeutic goods that is applied.
Findings: This gives you clear vision on how to file Drug master file in US, EUROPE, CANADA and AUSTRALIA. This paper also gives you the comparison of DMF fling procedure in the above-mentioned countries so that reader can have clear idea on how to file DMF and different concerns on DMF among the above counties.
Conclusion: The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, Packaging and the cGMP status of any Drug product for humans. The content and the format for Drug Master File is used to obtain marketing Authorization. The main objective of the DMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a marketing authorization grant. Now from 2016 onwards most of the regulated countries will use eCTD or their electronic format for their DMF submission.
Keywords
DMF, FDA, CDR, CMC, CEP, LOA, TGA, ACPM, ACSOM, NDS, MAA, ANDA.Full Text
References
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- Prescription medicine registration process , for the application lodged under the process of prescription registration process, Australian government, version 2 Available from https://www.tga.gov.au/ sites/default/iles/pm-argpm-process.pdf (Accessed on 30th march 2017)
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