Formulation and evaluation of a bilayer tablet comprising of diclofenac potassium as orodispersible layer and diclofenac sodium as sustained release core

Abbas, Jabbar; Bashir, Sajid; Samie, Muhammad; Laghari, Sadaf Hayat; Aman, Nargis; Jan, Habib Ullah

doi:10.12991/marupj.323595

Cited by 6 publications

(7 citation statements)

References 13 publications

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“…Nonsteroidal anti-inflammatory drugs )NSAIDs) have various side effects [ 1 ]. Diclofenac, as one of this category of drugs, is a phenylacetic acid derivative that has long been used as analgesic and an anti-inflammatory drug to treat certain conditions [ 2 ]. In its mechanism of action, diclofenac inhibits cyclooxygenase- (COX-) 2 enzymes with greater potency than it acts on COX-1 [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

Naringin and Hesperidin Counteract Diclofenac‐Induced Hepatotoxicity in Male Wistar Rats via Their Antioxidant, Anti‐Inflammatory, and Antiapoptotic Activities

Hassan

Hozayen

Sree

et al. 2021

Oxidative Medicine and Cellular Longevity

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This study is aimed at evaluating the preventive effect and at suggesting the mode of actions of naringin and hesperidin and their combination in diclofenac-induced hepatotoxicity. Male Wistar rats, intraperitoneally injected with diclofenac sodium (3 mg/kg b.wt/day), were orally treated with naringin (20 mg/kg b.wt/day) and hesperidin (20 mg/kg b.wt/day) and their combination for 4 weeks. The administrations of naringin and hesperidin to diclofenac-injected rats led to a significant decrease in the elevated serum ALT, AST, LDH, ALP, GGT, total bilirubin, TNF-α, and IL-17 levels as well as liver lipid peroxidation and liver p53 and caspase-3 mRNA expressions. In contrast, serum IL-4 level, liver GSH content, and liver GPx and SOD activities increased. In association, diclofenac-induced deleterious histological alterations including hydropic degeneration, cytoplasmic vacuolization, apoptosis, and focal hepatic necrosis of hepatocytes associated with inflammatory cells’ infiltration were remarkably improved by treatments with naringin and hesperidin. In conclusion, naringin, hesperidin, and their combination, which was the most potent, counteract diclofenac-induced liver injury via antioxidant, anti-inflammatory, and antiapoptotic actions. Thus, this study recommends the use of naringin and hesperidin or their combination to resolve the side effects of drugs like diclofenac on the liver.

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Section: Introductionmentioning

confidence: 99%

Naringin and Hesperidin Counteract Diclofenac‐Induced Hepatotoxicity in Male Wistar Rats via Their Antioxidant, Anti‐Inflammatory, and Antiapoptotic Activities

Hassan

Hozayen

Sree

et al. 2021

Oxidative Medicine and Cellular Longevity

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“…To get a uniform mixture the measured mass of diclofenac potassium, then Cross povidone, Avicel 200, and Primogel were passed from sieve 85 mesh followed by 15 minutes mixing of all ingredients. The lubricant and glidant i-e. magnesium stearate and Aerosil 200 were added and further mixed for five minutes and tablets were compressed by the method previously used by Abbas et al, 2017 and Gohel et al, 2010 [10,11]. Precompression studies were conducted before final compression.…”

Section: Preparation Of Orodispersible Layermentioning

confidence: 99%

“…The mixture was heated for 30 minutes at 70°C with continuous stirring. This hot solution was cooled filtered and diluted accurately; a sufficient amount of filtrate was analyzed by using a spectrophotometer at wavelengths of 276 nm [10,16].…”

Section: Sustained Release Corementioning

confidence: 99%

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Development, Feasibility Assessment and in-vitro Evaluation of Diclofenac Potassium Multilayered Tablets

Abbas

Yousuf

Laghari

et al. 2021

JPRI

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Introduction: Diclofenac potassium has widely been utilized as an analgesic and anti-inflammatory agent. To achieve rapid onset of action with prolonged therapeutic action is an immense need of time. In present project a study was conducted on preparation with physicochemical determination of diclofenac potassium tablets, this unique tablet have duel characteristics like rapid onset of action due to orodispersible coat and extended release of API due to sustained release core. Methodology: As diclofenac potassium is not sensitive to water so wet granulation method was efficiently employed to prepare the granules of sustained release core, while direct compression was done to prepare orodispersible outer coat layer in order to give rapid release. Results and Discussion: In evaluations granules characteristics and tablet properties were studied. Result of both pre compression and post compression studies were coming in pharmacopeia acceptable ranges. The orodispersible layer disintegrated with in 18sec, which gives sufficient amount of API as loading dose, in order to maintain the plasma drug concentration in therapeutic range the core will release drug in sustained manner within 10 hours in gastrointestinal tract (GIT) fluid (pH 6.8). The results of kinetic models were complying with Higuchi model. Conclusion: In present work, a rapid release outer dispersible layer of drug was constructed on a sustained release core. Results of study gives expected outcomes to maintained initial concentration of drug which persist for long time. The combination of sodium starch glycolate, dry starch, and cross povidone exhibited promising super disintegrant efficiency while Hydroxypropylmethyl cellulose K15 showed excellent sustained release properties.

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“…From this solution further make dilutions containing various concentrations. Absorbance was taken at 282 nm [18].…”

Section: Preparation Of Diclofenac Potassium Standard Curvementioning

confidence: 99%

Comparative Physicochemical Evaluation of Selective Brands of Diclofenac Potassium Tablets Available in Pakistan

Abbas

Ahmer

Yousuf

et al. 2020

JPRI

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The purpose of present effort was to conduct physiochemical evaluation of miscellaneous commercially available diclofenac potassium 75 mg tablets in the local market of Sindh, Pakistan. Further comparison was made among their different parameters. In study seven brands tagged as RB1 to RB7 were evaluated for diameter, thickness, disintegration time, and assay content and dissolution profile. Obtained results of all brands conformed to the official standard specification for disintegration test, Assay Content. The attained release rate profile during dissolution study revealed that all brands achieved more than 80% in sixty minutes. The spectrophotometric analysis for assay content of all brands was within 90%-110% which in good agreement with specified in the Unites States Pharmacopoeia. In the current study all the assessed products could be regarded as being chemically similar, while no product is found as a false product, these all brands can be used alternatively. The used spectrophotometric evaluation is very simple, reasonable, and easy to adopt for analysis and could be used in routine analysis of diclofenac potassium tablets, particularly in the unavailability of advanced equipment’s just like HPLC, LCMS & GC etc. which is not easily available and accusable in many institutions.

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Formulation and evaluation of a bilayer tablet comprising of diclofenac potassium as orodispersible layer and diclofenac sodium as sustained release core

Cited by 6 publications

References 13 publications

Naringin and Hesperidin Counteract Diclofenac‐Induced Hepatotoxicity in Male Wistar Rats via Their Antioxidant, Anti‐Inflammatory, and Antiapoptotic Activities

Naringin and Hesperidin Counteract Diclofenac‐Induced Hepatotoxicity in Male Wistar Rats via Their Antioxidant, Anti‐Inflammatory, and Antiapoptotic Activities

Development, Feasibility Assessment and in-vitro Evaluation of Diclofenac Potassium Multilayered Tablets

Comparative Physicochemical Evaluation of Selective Brands of Diclofenac Potassium Tablets Available in Pakistan

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