Generic Ibuprofen Research Articles

Analisa mutu tablet ibuprofen generik berlogo dan generik bermerek yang diproduksi industri X di Gresik

Ibuprofen tablets are one of the most widely used antipyretic analgesic drugs for self-medication in pharmacies. According to the Biopharmaceutical Classification System (BCS), Ibuprofen is included in Class II or drugs with low solubility, but high permeability. This study was carried out to determine the physical quality of branded generic and branded generic ibuprofen drugs. This research was carried out by dissolution testing on ibuprofen tablets. The results obtained from the physical quality test met the specified requirements. The dissolution test showed that Q30 had dissolved more than 70%. The conclusion is that the drug meets the requirements and there is no difference between generic drugs with the logo and branded generics.

The structural diversity of ibuprofen sustained-release pellets on the same goal of bioequivalence consistency

The consistency evaluation, which is largely unexplored is crucial in regulating the quality and efficacy of generic drugs. In this report, after generic ibuprofen (IBU) sustained-release pellets were developed and validated as bioequivalent to the reference list drug (RLD) in 48 healthy human volunteers (p < 0.001***), three-dimensional (3D) structures of generic IBU pellets from bioequivalence tests, along with RLD were investigated and compared for architecture using Micro-computed tomography (Micro-CT). The surface and internal architectures of the pellets, sphericity, pellet volume, core volume and gray value have been evaluated in both static and dynamic conditions. The material distribution and composition of IBU pellets were characterized using synchrotron radiation-FTIR mapping. Although the structures of RLD and the generic products were not similar dynamically, identical release profiles and bioequivalence were obtained. Overall, micro-CT could be very useful for characterization of internal structure, material design and development of new dosage form.

PENGARUH PENAMBAHAN POLIETILEN GLIKOL 6000 PADA TABLET IBUPROFEN DISPERSI PADAT TERHADAP ABSORBSI IBUPROFEN SECARA IN SITU

Drug absorption can be decided by various methods, namely in vitro methods, in situ methods, and in vivo methods. The in situ method is a procedure that is very close to the in vivo method. The aim of this study was to identify the effect of accumulation of polyethylene glycol 6000 (PEG 6000) on solid dispersion of ibuprofen tablets on the in-situ absorption of the drug. This research was conducted through an experiment to determine the effect of adding polyethylene glycol 6000 to the absorption of ibuprofen in situ by flowing the solution from solid dispersion ibuprofen tablets, solutions from generic ibuprofen tablets and standard ibuprofen solutions. The solid dispersion system was carried out by melting ibuprofen and polyethylene glycol 6000 in a ratio of 1:05. The drug solution was flowed through the lumen of the small intestine of male rats. Unabsorbed ibuprofen was measured by an ultraviolet spectrophotometer at a wavelength of 225.5 nm. Next, the absorbed level of ibuprofen was calculated. The results showed that ibuprofen from solid dispersion tablets was absorbed more than ibuprofen from generic tablets and standard ibuprofen. It can be concluded that polyethylene glycol 6000 has an effect on the absorption of ibuprofen in situ.

Primena spektrofotometrije u in vitro studiji poređenja brzine oslobađanja aktivne supstance iz brendiranih i generičkih tableta ibuprofena

The dissolution test is a simple and important in vitro method for assessing the bioequivalence, which aims to compare the bioavailability of generic and branded drugs. It implies the use of a proper apparatus (usually pharmacopoeially defined) in which the dosage form is dissolved, and the dissolution process itself is monitored/quantified using an appropriate analytical method among which high-performance liquid chromatography (HPLC) is widely used. Spectrophotometry could be a significant substitute, through its advantages in terms of simplicity and costs of analysis. In the present study, possible differences in bioavailability between branded and generic ibuprofen coated tablets were predicted using a dissolution test for solid dosage forms. The ibuprofen content and the amount of ibuprofen released in the dissolution test were determined using a simple spectrophotometric method. Based on the obtained results, no significant differences in the dissolution rate of ibuprofen from generic and branded coated tablets were observed. It can be concluded that the spectrophotometric method applied for the dissolution test, among other suitable methods, could be used for bioequivalence screening in conditions where rapid and simple assessment is required or where HPLC method is not available.

Causal Inference With Two Versions of Treatment

Causal effects are commonly defined as comparisons of the potential outcomes under treatment and control, but this definition is threatened by the possibility that either the treatment or the control condition is not well defined, existing instead in more than one version. This is often a real possibility in nonexperimental or observational studies of treatments because these treatments occur in the natural or social world without the laboratory control needed to ensure identically the same treatment or control condition occurs in every instance. We consider the simplest case: Either the treatment condition or the control condition exists in two versions that are easily recognized in the data but are of uncertain, perhaps doubtful, relevance, for example, branded Advil versus generic ibuprofen. Common practice does not address versions of treatment: Typically, the issue is either ignored or explicitly stated but assumed to be absent. Common practice is reluctant to address two versions of treatment because the obvious solution entails dividing the data into two parts with two analyses, thereby (a) reducing power to detect versions of treatment in each part, (b) creating problems of multiple inference in coordinating the two analyses, and (c) failing to report a single primary analysis that uses everyone. We propose and illustrate a new method of analysis that begins with a single primary analysis of everyone that would be correct if the two versions do not differ, adds a second analysis that would be correct were there two different effects for the two versions, controls the family-wise error rate in all assertions made by the several analyses, and yet pays no price in power to detect a constant treatment effect in the primary analysis of everyone. Our method can be applied to analyses of constant additive treatment effects on continuous outcomes. Unlike conventional simultaneous inferences, the new method is coordinating several analyses that are valid under different assumptions, so that one analysis would never be performed if one knew for certain that the assumptions of the other analysis are true. It is a multiple assumptions problem rather than a multiple hypotheses problem. We discuss the relative merits of the method with respect to more conventional approaches to analyzing multiple comparisons. The method is motivated and illustrated using a study of the possibility that repeated head trauma in high school football causes an increase in risk of early onset cognitive decline.

Changing perceptions and efficacy of generic medicines: An intervention study.

Generic medicines provide a safe and economical medical treatment and are used routinely throughout the world. However, a significant proportion of individuals view generic medicines as less safe, less effective and of lower quality compared with their equivalent branded medicines. This study aimed to investigate the effect of an educational intervention on improving perceptions and perceived efficacy of generic medicines. Seventy participants who experienced frequent tension headaches were randomized to receive an educational video about generic medicines or a control video. Participants then alternatively took branded and generic ibuprofen to treat their next two consecutive headaches. Changes in perceptions of generic medicines, pain relief and side effects were measured. The intervention was effective in modifying and improving perceptions of generic medicines in the areas of understanding (p < .05), preference for a generic medicine to treat a serious illness (p < .05), and overall preference for generic medicines (p < .01). However, contrary to predictions, participants in the intervention group reported significantly less pain relief (p = .03) and more symptoms (p = .04) after taking generic ibuprofen compared with branded ibuprofen. This study identified that an educational intervention is effective in modifying and improving perceptions of generic medicines but produced paradoxical effects on drug efficacy and side effects. These findings suggest that complex mechanisms are involved in the relationship between perceptions and drug efficacy and contradict the assumption that improving attitudes toward generic medicines will have a flow-on effect to improving health outcomes. (PsycINFO Database Record

Surface analysis using a new plasma assisted desorption/ionisation source for mass spectrometry in ambient air

The authors report on a modified micro-plasma assisted desorption/ionisation (PADI) device which creates plasma through the breakdown of ambient air rather than utilising an independent noble gas flow. This new micro-PADI device is used as an ion source for ambient mass spectrometry to analyse species released from the surfaces of polytetrafluoroethylene, and generic ibuprofen and paracetamol tablets through remote activation of the surface by the plasma. The mass spectra from these surfaces compare favourably to those produced by a PADI device constructed using an earlier design and confirm that the new ion source is an effective device which can be used to achieve ambient mass spectrometry with improved spatial resolution.

Development of a taste-masked generic ibuprofen suspension: Top-down approach guided by electronic tongue measurements

Electronic tongues are sensor array systems that are increasingly being used in the field of pharmaceutics to provide taste assessment data of formulations. The applicability of an electronic tongue in the development of a taste masked generic ibuprofen suspension, starting from a commercial taste masked product, was evaluated in this study. The initial screening study on 3 proprietary and 11 generic products showed that sensors of the taste sensing system TS-5000Z could clearly detect differences between the products. The variation of sensor responses were mainly caused by sodium salts, sweeteners, and preservatives, whereas pH and viscosity did not affect sensor response. In addition, the presence of the particles (20–100 µm) did not damage the sensor membranes. Based on this screening, and the known qualitative composition of the proprietary formulations, the approximate quantitative composition of a proprietary formulation could be deduced and a taste masked generic formulation could be developed using the electronic tongue data. Differences in sensor responses between the proprietary and optimized generic formulation were smaller than 11mV for each sensor. Based on these results a rational approach of implementing an electronic tongue to simplify the development of a taste masked generic formulation could be introduced. © 2011 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:4460–4470, 2011

Comparative study of anti-inflammatory activity of some branded generic and generic non-steroidal anti-inflammatory drugs

Generic drugs play a very important role in health care. A study was undertaken to ascertain the equality or inequality between generics and branded generics. NSAIDs are the most commonly used drugs. So these drugs were chosen for the study. Selected branded generic and generic products of ibuprofen, nimesulide, and diclofenac sodium were tested by oral administration of their suspensions to different groups of rats. Freshly prepared drug suspensions equivalent to doses of 40, 10, and 5 mg/kg of ibuprofen, nimesulide, and diclofenac sodium, respectively, were administered orally to the rats and anti-inflammatory activity was measured by the carrageenan-induced rat paw edema model employing Zeitlin’s apparatus to measure the paw thickness. Statistical analysis by t-test, of the activity at the point of maximum difference indicated that with respect to anti-inflammatory activity generic ibuprofen and generic diclofenac sodium are better than branded generic ibuprofen and branded generic diclofenac sodium, r...

He who shouts loudest - shifting from Rx to OTC status

Nurofen®, an over-the-counter (OTC) preparation of the analgesic ibuprofen, is often held up as one of the best planned prescription to OTC switches. Yet even this has not been enough to protect it from erosion by generic ibuprofen. As delegates at the conference ‘Managing Rx to OTC Switches’ held in London last week heard, more aggressive branding strategies are being advocated to protect future switches from this fate.

Opinions of Mississippi Pharmacists on the OTC Status of Ibuprofen

A mail survey was sent to all owners of community pharmacists in Mississippi, yielding a res onse from 265 (31.7%) P usable for this study. Most respondents felt that ibuprofen was a good chioce for the switch, was safe for OTC use, and should not be reimbursable as an OTC under third party programs. The largest effect of the switch was believed to be in decreased sales for aspirin and for prescriptions for Motrin. Generic ibuprofen and Advil were the most frequently recommended.

Opinions of Mississippi Pharmacists on the OTC Status of Ibuprofen

A mail survey was sent to all owners of community pharmacists in Mississippi, yielding a res onse from 265 (31.7%) P usable for this study. Most respondents felt that ibuprofen was a good chioce for the switch, was safe for OTC use, and should not be reimbursable as an OTC under third party programs. The largest effect of the switch was believed to be in decreased sales for aspirin and for prescriptions for Motrin. Generic ibuprofen and Advil were the most frequently recommended.