Quality assessment of nine brands of metformin hydrochloride tablets marketed in Abuja, Nigeria

Metformin is a drug of first choice in management of type II diabetes mellitus and the Nigerian market is flooded with many brands of metformin tablets. The aim of this study is to assess the pharmaceutical quality of nine brands of metformin tablets circulating in pharmacy outlets in Abuja. The brands were assessed for uniformity in weight, hardness, friability, disintegration time and in vitro dissolution using official methods. The content of active ingredient was also determined spectrophotometrically. All the brands had weights within the official limits, hardness was found to differ across the brands with values ranging between 1.20 and 11.50 kgF. Friability values were between 0.00 and 2.25%, disintegration time was between 2.06 and 10.36 min and within official specifications for film-coated tablets. Drug release within 60 min was between 93 and 103%, however, one of the brands fell outside the lower limit of the official specification and therefore, failed the dissolution test. Similarly, all but one of the brands were within the official specification of the percent content of active ingredient. The results highlight the need to routinely carry out market surveillance on drug products so as to safeguard the health of patients.

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Comparative Evaluation of Some Commercial Clopidogrel Tablets Available in Yemen

Majalah Farmaseutik ◽

10.22146/farmaseutik.v13i2.40917 ◽

2018 ◽

Vol 13 (2) ◽

pp. 79

Author(s):

Bassam Abduh Ali ◽

Mohammed Gameel Al-haddad ◽

Abdullah Ahmed Areqi

Keyword(s):

Quality Parameters ◽

In Vitro Dissolution ◽

Dissolution Time ◽

Dissolution Profile ◽

Disintegration Time ◽

Weight Variation ◽

Quality Control Parameters ◽

Variation Range

Clopidogrel is a medication to reduce the risk of heart disease and taken orally. Quality of drug characterizes the production process and every phamaceutical company strives for it but often it is very difficult to achieve. This study was to investigate quality control parameters of some marketed Clopidogrel tablets. To assess the quality, eight different marketed brands of Clopidogrel 75 mg tablets available in Yemeni market collected from different pharmacies in Hodeida city. Different quality parameters like weight variation, hardness, thickness and friability were determined according to established protocols. Then the in-vitro dissolution test, potency, disintegration time were also carried out. UV-spectrophotometer was used to determine the percentage released and assay at 218 nm. All the brands comply the requirements of Pharmacopoeia as they showed acceptable weight variation range. Friability of all brands was less than 1% and no significant differences in disintegration times as they disintegrated within 15 minutes. In case of dissolution profile, all brands except C6 showed acceptable dissolution time as they released more than 60% of drug in 45 minute. The hardness of only two brands was within the range. All brands also meet the potency specifications. This study suggested that most commercially Clopidogrel tablets in Yemen maintain the quality and comply with the pharmacopeia specifications.

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The effect of Milgamma NR and SperminR on in vitro cellular immune reactions in patients with type II diabetes mellitus

Immunology Letters ◽

10.1016/s0165-2478(97)88807-4 ◽

1997 ◽

Vol 56 (1-3) ◽

pp. 482

Author(s):

M Horváth

Keyword(s):

Diabetes Mellitus ◽

Type Ii Diabetes ◽

Type Ii Diabetes Mellitus ◽

Type Ii ◽

Immune Reactions ◽

Cellular Immune

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Formulation and Evaluation of Fast Disintigrating Meloxicam Tablets and Its Comparison with Marketed Product

International Journal of Drug Delivery Technology ◽

10.25258/ijddt.v2i2.8846 ◽

2010 ◽

Vol 2 (2) ◽

Author(s):

Suresh Kulkarni ◽

Ranjit P. ◽

Nikunj Patel ◽

Someshwara B. ◽

Ramesh B. ◽

...

Keyword(s):

Water Absorption ◽

In Vitro Dissolution ◽

Thickness Variation ◽

Wet Granulation ◽

Disintegration Time ◽

Absorption Ratio ◽

Wetting Time ◽

Fast Disintegrating Tablets ◽

Cox 1

The present investigation deals with the formulation of fast disintegrating tablets of Meloxicam that disintegrate in the oral cavity upon contact with saliva and there by improve therapeutic efficacy. Meloxicam is a newer selective COX-1 inhibitor. The tablets were prepared by wet granulation procedure. The influence of superdisintegrants, crosspovidone, croscaremellose sodium on disintegration time, wetting time and water absorption ratio were studied. Tablets were evaluated for weight and thickness variation, disintegration time, drug content, in vitro dissolution, wetting time and water absorption ratio. The in vitro disintegration time of the best fast disintegrating tablets was found to be 18 sec. Tablets containing crospovidone exhibit quick disintegration time than tablets containing croscaremellose sodium. The fast disintegrating tablets of Meloxicam with shorter disintegration time, acceptable taste and sufficient hardness could be prepared using crospovidone and other excipients at optimum concentration.

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Design, Optimization and Evaluation of Fast-Dissolving Oral Films of Ropinirole

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2018.11.1.3 ◽

2018 ◽

Vol 11 (1) ◽

pp. 3958-3967

Author(s):

Bhikshapathi D. V. R. N. ◽

Srinivas A

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Good Alternative ◽

In Vitro Dissolution ◽

Content Uniformity ◽

Onset Of Action ◽

Disintegration Time ◽

Peg 4000 ◽

Oral Films

The main objective of this study was to develop fast dissolving oral films of ropinirole HCl to attain quick onset of action for the better management of Parkinson’s disease. Twenty-seven formulations (F1-F27) of ropinirole oral dissolving films by solvent-casting method using 33 response surface method by using HPMC E15, Maltodextrin PEG 4000 by using Design of experiment software. Formulations were evaluated for their physical characteristics, thickness, folding endurance, tensile strength, disintegration time, drug content uniformity and drug release characteristics and found to be within the limits. Among the prepared formulations F4 showed minimum disintegration time 11 sec, maximum drug was released i.e. 99.68 ± 1.52% of drug within 10 min when compared to the other formulations and finalized as optimized formulation. FTIR data revealed that no interactions takes place between the drug and polymers used in the optimized formulation. The in vitro dissolution profiles of marketed product and optimized formulation was compared and found to be the drug released was 92.77 ± 1.52 after 50 min. Therefore, it can be a good alternative to conventional ropinirole for immediate action. In vitro evaluation of the ropinirole fast dissolving films confirmed their potential as an innovative dosage form to improve delivery and quick onset of action of ropinirole. The oral dissolving film is considered to be potentially useful for the treatment of Parkinson’s disease where quick onset of action is desired

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Formulation and Evaluation of Orally Disintegrating Tablets of Lamotrigine

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2015.8.2.11 ◽

2015 ◽

Vol 8 (2) ◽

pp. 2881-2888

Author(s):

Sudarshan Singh ◽

S S Shyale ◽

P Karade

Keyword(s):

Drug Release ◽

Water Soluble ◽

In Vitro Dissolution ◽

Disintegration Time ◽

Orally Disintegrating Tablet ◽

Drug Content ◽

Weight Variation ◽

Wetting Time ◽

Croscarmellose Sodium

The aim of this study was to design orally disintegrating tablet (ODT) of Lamotrigine. It is an Antiepileptic drug which is widely used in epilepsy. It is also used in simple and complex partial seizures and secondary generalized tonic-clonic seizures. It is poorly water soluble drug (0.46 mg/ml). Thus, an attempt was made to enhance the water solubility by complexation with β-cyclodextrin (1:1 molar ratios). The orally disintegrating tablet of lamotrigine was prepared by direct compression method using different concentration of superdisintegrants such as Sodium starch glycollate, croscarmellose sodium by sublimating agent such as camphor. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies. The prepared tablets were characterized by Fourier transform infrared spectroscopy and differential scanning calorimetry. The disintegration time for the complexed tablets prepared by different concentration of superdisintegrants was found to be in range of 32.54 ± 0.50 to 55.12 ± 0.57 sec and wetting time of the formulations was found to be in range of 28.47 ± 0.67 to 52.19 ± 0.72 sec. All the formulation showed almost 100 percent of drug release within 15 min. Among all the formulation F6 and F7 prepared with 18% croscarmellose sodium and camphor shows faster drug release, respectively 10 min, F6 gives good result for disintegration time, drug release, wetting time and friability. Further formulations were subjected to stability testing for 30 days at temperature of 40 ± 5 ºC/75 ± 5 %RH. Tablets showed no appreciable changes with respect to physical appearance, drug content, disintegration time and dissolution profiles. Results were statistically analyzed by one-way ANOVA at a p < 0.05. It was found that, the data at any point of time are significant at p < 0.05.

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DESIGN, OPTIMIZATION AND EVALUATION OF CETRIZINE DIHYDROCHLORIDE FAST DISSOLVING FILMS EMPLOYING STARCH TARTRATE–A NOVEL SUPERDISINTEGRANT

International Journal of Current Pharmaceutical Research ◽

10.22159/ijcpr.2019v11i6.36347 ◽

2019 ◽

pp. 75-86

Author(s):

R. SANTOSH KUMAR ◽

ANNU KUMARI ◽

B. KUSUMA LATHA ◽

PRUDHVI RAJ

Keyword(s):

Tensile Strength ◽

Drug Dissolution ◽

In Vitro Dissolution ◽

Content Uniformity ◽

Scanning Calorimetry ◽

Disintegration Time ◽

Folding Endurance ◽

Contour Plots ◽

The Individual

Objective: The aim of the current research is optimization, preparation and evaluation of starch tartrate (novel super disintegrant) and preparation of fast dissolving oral films of cetirizine dihydrochloride by employing starch tartrate. Methods: To check the drug excipient compatibility studies of the selected drug (Cetrizine dihydrochloride) and the prepared excipient i. e starch tartrate, different studies like FTIR (Fourier-transform infrared spectroscopy), DSC (Differential scanning calorimetry) and thin-layer chromatography (TLC) were carried out to find out whether there is any interaction between cetirizine dihydrochloride and starch tartrate. The solvent casting method was used for the preparation of fast dissolving films. The prepared films were then evaluated for thickness, folding endurance, content uniformity, tensile strength, percent elongation, in vitro disintegration time and in-vitro dissolution studies. Response surface plots and contour plots were also plotted to know the individual and combined effect of starch tartrate (A), croscarmellose sodium (B) and crospovidone (C) on disintegration time and drug dissolution efficiency in 10 min (dependent variables). Results: Films of all the formulations are of good quality, smooth and elegant by appearance. Drug content (100±5%), thickness (0.059 mm to 0.061 mm), the weight of films varies from 51.33 to 58.06 mg, folding endurance (52 to 67 times), tensile strength (10.25 to 12.08 N/mm2). Fast dissolving films were found to disintegrate between 34 to 69 sec. Percent dissolved in 5 min were found to be more in F1 formulation which confirms that starch tartrate was effective at 1%. Conclusion: From the research conducted, it was proved that starch tartrate can be used in the formulation of fast dissolving films of cetirizine dihydrochloride. The disintegration time of the films was increased with increase in concentration of super disintegrant.

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Formulation and Evaluation of Sustained Release Bilayer Matrix Tablet of Glimepiride and Metformin Hydrochloride

Asian Journal of Research in Pharmaceutical Science ◽

10.52711/2231-5659.2021.00043 ◽

2021 ◽

pp. 273-279

Author(s):

Mayuri B. Patil ◽

Avish D. Maru ◽

Jayshree S. Bhadane

Keyword(s):

Sustained Release ◽

Type Ii Diabetes ◽

In Vitro Release ◽

Angle Of Repose ◽

Metformin Hydrochloride ◽

Wet Granulation ◽

Matrix Tablet ◽

Type Ii ◽

Weight Variation

The aim of the present study was to design and evaluate bilayer tablets of metformin hydrochloride as sustained release form for the treatment of Type-II diabetes mellitus. The basic aim of any Bi-layer tablet formulation is to separate physically or chemically incompatible ingredients and to produce repeat action or prolonged action of tablet. They are many drugs for treating type-II diabetes. Sulphonyl urea and biguanides are used commonly by a wide section of patients. Melt granulation process was used for the formulation of sustained comprising metformin layer and wet granulation of immediate comprising layer of glimepiride. The precompression studies like bulk density, tapped density, angle of repose, compressible index and post formulation studies includes weight variation, hardness, thickness, friability and dissolution study. The in-vitro release profile of Glimepiride was dissolved within 45 min, and Metformin Hydrochloride was able to release more than 12 hrs. They all the formulation was optimized formula due to its higher rate of dissolution and collate all other parameters with the official specifications.

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Formulation and Evaluation of Orodispersible Tablets Containing Taste Masked Mirabegron Resinate

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.00824 ◽

2021 ◽

pp. 4736-4742

Author(s):

Sarika S. Malode ◽

Milind P. Wagh

Keyword(s):

Overactive Bladder ◽

Bitter Taste ◽

In Vitro Release ◽

In Vitro Dissolution ◽

Dissolution Time ◽

Disintegration Time ◽

Orodispersible Tablets ◽

Weight Variation

The objective of present work was to develop taste masked orodispersible tablets of mirabegron. Mirabegron is beta 3 adrenoceptor agonist used to treat overactive bladder. Overactive bladder (OAB) is defined as a symptom syndrome showing feeling of urgency to urinate, typically accompanied by frequent daytime and nocturnal urination, in the absence of proven infection or other obvious pathology. Over active bladders are generally common in geriatrics. Moreover, this drug has a very strong bitter taste. Frequent dosing requires frequent water intake, which further aggregates the condition of over active bladder and bitter taste of drug affects patient compliance. Hence a need arises to mask the bitter taste for development of an ODT which does not require consuming water with every dosage. In this work, the bitter taste of mirabegron was masked by forming a complex with an ion exchange resin tulsion 344. The drug resin complexation process was optimized for resin activation, drug: resin ratio, soaking time and stirring time. In –vitro release studies revealed complete drug elution from the complex within 10 minutes in pH 1.2 buffer. The taste-masked complex was then formulated into palatable orodispersible tablets using a direct compression approach by use of superdisintegrants to achieve a rapid disintegration. The tablets were evaluated for weight variation, hardness, friability, drug content, wetting time, In- vivo disintegration time and in-vitro dissolution time.

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