Fat Grafting for Gluteal Augmentation: A Systematic Review of the Literature and Meta-Analysis.

BACKGROUND: With the increasing demand for gluteal fat augmentation, reports of fatal complications have surfaced. Therefore, the authors proposed to analyze the published techniques and compare different protocols, to identify those of potential concern. METHODS: A systematic review of the literature was performed with a search of 21 terms on the PubMed, MEDLINE, Cochrane, and Scientific Electronic Library Online databases. Nineteen articles meeting our predetermined criteria were analyzed, and data from the different steps of the procedure were classified, allowing evaluation and comparison of techniques. Independent-samples t test and one-way analysis of variance were used for statistical analysis. RESULTS: Seventeen case series and two retrospective studies including 4105 patients were reviewed. Most articles were authored in Colombia, Mexico, and Brazil. Most procedures were performed on adult female patients under general anesthesia. Fat was harvested using a tumescent technique from the lower extremities and the back, with machine-vacuum suction. A mean of 400 ml of decanted lipoaspirate was injected into each gluteal region, mostly subcutaneously and intramuscularly with 60-ml syringes. Most patients rated their results as "excellent." The mean complication rate was 7 percent (6.7 percent minor, 0.32 percent major), with no significant relation to the planes of injection. CONCLUSIONS: Fat grafting is an effective and predictable way to remodel the gluteal region; however, the procedure is not without risks. Avoiding gluteal vessel damage may prevent most feared complications, such as fat embolism. Accurate analysis, systematization of the procedure, and reporting cases in the fat grafting registry may provide the foundation for optimization of outcomes. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Analysis of the vertical mammaplasty design in skin-sparing mastectomy and immediate autologous reconstruction.

BACKGROUND: Skin-sparing mastectomy designs for immediate autologous breast reconstruction include racquet, Wise, and vertical mammaplasty incisions. The vertical design addresses ptosis while maintaining viable skin flaps. This study compares the racquet to the vertical incision. METHODS: Immediate skin-sparing autologous breast reconstructions by a single surgeon using either vertical or racquet incisions from August 2006 to September 2011 were analyzed. Aesthetic scoring was based on a Likert-scale assessment of scar appearance, shape, preoperative versus postoperative aesthetic comparison, and overall aesthetic outcome. Responses were analyzed using the Mann-Whitney test. RESULTS: Seventy-seven patients (48 racquets and 29 vertical) were included. Patient demographics and complications did not differ. Vertical design reconstructions were used for patients with higher-grade ptosis (p < 0.001). Significantly better-appearing scars (3.8 vs. 3.5; p = 0.04) were observed in the vertical group. Vertical reconstructions showed a trend toward significance in cosmetic improvement compared with preoperative appearance (3.2 vs. 3.0; p = 0.06). There was no difference in shape (vertical 3.6, racquet 3.6; p = 0.86) or in postoperative aesthetic result (vertical 3.6, racquet 3.4; p = 0.41). CONCLUSIONS: Shape and overall postoperative aesthetic appearance did not significantly differ despite greater ptosis preoperatively in the vertical group, demonstrating the efficacy of the vertical design in reconstruction. Vertical design reconstructions were rated aesthetically superior to their pre-mastectomy appearance. Significantly better scar scores in the vertical group reflect the camouflaged nature of vertical incisions. These results demonstrate that the aesthetic outcome of the vertical design reconstruction in ptotic breasts is as good as and potentially superior to the racquet design reconstruction in non-ptotic breasts.

The scope of plastic surgery according to 2434 allopathic medical students in the United States.

BACKGROUND: The general public and physicians often equate plastic surgery with cosmetic surgery. The authors investigate whether this perception is present in U.S. medical students. METHODS: A national survey of first- and second-year allopathic medical students was conducted. Students were asked to determine whether 46 specific procedures are performed by plastic surgeons: 12 aesthetic and 34 reconstructive procedures, which were further separated into three subgroups (general reconstruction and breast, craniofacial, and hand and lower extremity). RESULTS: Of the questionnaires sent out, 2434 from 44 medical schools were returned completed (23 percent response rate); 90.7 percent of aesthetic, 66.0 percent of general reconstruction and breast, 51.0 percent of craniofacial, and 33.4 percent of hand and lower extremity procedures were correctly identified. There was no relationship with self-reported interest in plastic surgery (1 = not at all interested to 10 = extremely interested) and the number of correctly identified aesthetic procedures. However, there was a nonlinear relationship with correctly identified reconstructive procedures; compared to those with an interest level of 1 to 5, those who chose 10 scored on average 6.5 points higher (14.2 versus 20.7) (p < 0.01). An anticipated career in surgery was associated with more correctly identified procedures across all sections but neither year (first versus second) nor region (Northeast, South, Central, West) with any section. CONCLUSIONS: U.S. medical students are unaware of the true scope of plastic surgery. Early exposure to basic aspects of plastic surgery could serve as a means of increasing interest and knowledge in the field and help educate future generations of referring physicians.

A survey of patient comprehension of readily accessible online educational material regarding plastic surgery procedures.

PURPOSE: When an elective procedure is under consideration, the Internet may often be the first resource utilized by a patient. OBJECTIVES: The goal of the present study was to examine the comprehension of readily available online educational material by the patient population in a single plastic surgery clinic. METHODS: Two 5-question surveys were constructed: 1 for breast augmentation and 1 for rhinoplasty, each based on explanatory passages from patient education sections of the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) websites. Demographic data were also collected. One hundred patients who presented to the University Hospital in Newark, New Jersey, completed the survey. RESULTS: Mean patient age was 38.8 years. Mean number of completed educational years was 11.7. Across all groups, the mean score recorded was 3.41 out of a possible 5, with 1 point being assigned for each correct answer. The mean score was 3.54 for the ASPS website and 3.28 for the ASAPS website. The mean score was 3.26 for the breast augmentation survey and 3.56 for rhinoplasty. Neither difference was significant. CONCLUSIONS: No significant difference in scores was noted between websites or procedures. Patients understood the majority of the information presented in the passage provided to them. It is unrealistic to expect a patient to answer all questions correctly, although 23% of participants did. Patients appear to understand the material and are able to subsequently apply this knowledge to an objective measure of comprehension.

Biobrane in the management of critical microsurgical wounds of the upper extremity.

PURPOSE: Evolving soft tissue necrosis and/or edema can complicate microsurgical reconstruction by leading to open wounds with exposure of critical structures: anastamosed vessels, nerves, and tendons. Not infrequently, primary closure of these wounds is not possible. Immediate skin grafting may lead to anatomical and/or functional failure of reconstructed structures, compromising immediate or long-term functional outcomes. In addition, local tissues are often unavailable, and free tissue transfer in those settings could be ill-advised, especially for small wounds. METHODS: All of the senior author's microsurgical cases were reviewed. Four cases of replantation and one microsurgical reconstruction, where biologic dressings were used to treat critical wounds, were identified and are presented in this study along with an algorithm for the management of these types of wounds. RESULTS: Biologic dressings are simple, effective, and reliable tools for intermediate treatment of critical microsurgical wounds. Flap or replant viability was preserved in 100% of cases without compromising functional results. CONCLUSIONS: Biologic dressings can be used safely to treat microsurgical wounds with exposed critical structures. This use of a biologic dressing greatly simplifies the management of these types of wounds, avoiding the need for complex surgical intervention.

Complications following expander/implant breast reconstruction utilizing acellular dermal matrix: a systematic review and meta-analysis.

BACKGROUND: The recent increase in popularity of acellular dermal matrix assistance in immediate expander/implant breast reconstruction has led to variety of viewpoints. Many studies are published indicating an increase in complications with the use of acellular dermal matrix, while others indicate there is no increase in complications. METHODS: This meta-analysis utilizes information from available studies that directly compare one specific type of acellular dermal matrix with traditional methods of immediate expander/implant breast reconstruction. Eight studies were found through a meticulous literature search that met these criteria. RESULTS: There was more than a 2-fold increase in the number of infections and explanations in the acellular dermal matrix group compared to the control. There was a 3-fold increase in seroma formation in the acellular dermal matrix group compared to the control. There was a significant difference of intraoperative fill volumes between the acellular dermal matrix group compared to the control. CONCLUSIONS: This study illustrates that after pooling all available date regarding the use of acellular dermal matrix in immediate expander/implant breast reconstruction there appears to be an increased rate of complications. However, the increased intraoperative fill volume may lead to ultimately greater patient satisfaction.

Analysis of comprehensibility of patient information regarding complex craniofacial conditions.

PURPOSE: Health care consumers are increasingly turning to the Internet for information regarding medical and surgical procedures. When an elective procedure is under consideration, the Internet is often the first resource used by a patient. Caregivers of craniofacial patients are typically overwhelmed during the surgical planning process. A firm understanding of craniofacial condition and the associated procedures is crucial to obtain satisfactory outcomes. Furthermore, health care providers are increasingly referring their patients to on-line sources of patient education material. Currently, the National Institutes of Health suggests the information be at the fourth- to sixth-grade reading level to maximize comprehension. Much of the information available regarding health care targeted at patients is written at a 10th-grade reading level or higher. The purpose of this study was to evaluate readily available on-line patient education information for readability; being aware of this information will aid craniofacial surgeons in appropriately educating their patients. METHODS: Texts were extracted from commonly used craniofacial educational Web sites regarding reconstructive procedures. Three objective and accepted methods (SMOG, Flesch-Kincaid, and Dale-Chall) were used to assess readability of each condition and its corresponding procedure's text. RESULTS: The results from all 3 of the methods used were higher than the recommended seventh-grade reading level. The mean reading level for eMedicine was 13.8, 15.2, and 15 for the Flesch-Kincaid, SMOG, and Dale-Chall methods, respectively. Likewise, the mean reading levels for FACES were 7.5, 10.7, and 8.3; and for World Craniofacial Foundation, the levels were 11.9, 13.8, and 13. CONCLUSIONS: Patient education and understanding is a critical factor in planning for surgery; this is especially true of reconstructive craniofacial procedures. Craniofacial surgery is a diverse field, and its surgeons have correspondingly diverse practices. It is up to each individual surgeon to determine what is appropriate for his or her patients. Our results show that on-line educational material is at a level that is substantially higher than the national reading average. The ultimate impact of this fact will vary from practice to practice, but all surgeons should be aware of the possible conflicts between information distributed and the patient's ability to comprehend that information. This may assist surgeons in preoperative evaluations by discussing conditions with more level appropriate means.

Developing oral drug delivery systems using formulation by design: vital precepts, retrospect and prospects.

INTRODUCTION: Over the past few decades, the domain of drug formulations has metamorphosed from the conventional tablets and capsules to advanced and intricate drug delivery systems (DDS), both temporal and spatial. Formulation development of the oral DDS, accordingly, cannot be adequately accomplished using the traditional 'trial and error' approaches of one variable at a time. This calls for the adoption of rational, systematized, efficient and cost-efficient strategies using 'design of experiments (DoE)'. The recent regulatory guidelines issued by the key federal agencies to practice 'quality by design (QbD)' paradigms have coerced researchers in industrial milieu, in particular, to use experimental designs during drug product development. AREAS COVERED: This review article describes these principles of DoE and QbD as applicable to drug delivery development using a more apt expression, that is, 'formulation by design (FbD)'. The manuscript describes the overall FbD methodology along with a summary of various experimental designs and their application in formulating oral DDS. The article also acts as a ready reckoner for FbD terminologies and methodologies. Select literature and an extensive FbD case study have been included to provide the reader with a comprehensive portrayal of the FbD precept. EXPERT OPINION: FbD is a holistic concept of formulation development aiming to design more efficacious, safe, economical and patient-compliant DDS. With the recent regulatory quality initiatives, implementation of FbD has now become an integral part of drug industry and academic research.

Formulation optimization of hydrodynamically balanced oral controlled release bioadhesive tablets of tramadol hydrochloride.

The directly compressible floating-bioadhesive tablets of tramadol were formulated using varying amounts Carbopol 971P (CP) and hydroxy-propylmethyl cellulose (HPMC), along with other requisite excipients. In vitro drug release profile, floatational characteristics and ex vivo bioadhesive strength using texture analyzer were determined, and systematically optimized using a 3(2) central composite design (CCD). The studies indicated successful formulation of gastroretentive compressed matrices with excellent controlled release, mucoadhesion and hydrodynamic balance. Comparison of the dissolution profiles of the optimized formulation, with optimal composition of CP:HPMC :: 80.0:125.0, with that of the marketed controlled release formulation other indicated analogy of drug release performance with each other. Validation of optimization study using eight confirmatory experimental runs indicated very high degree of prognostic ability of CCD with mean  SEM of â0.06%  0.37. Further, the study successfully unravels the effect of the polymers on the selected response variables.

Formulation development of oral controlled release tablets of hydralazine: optimization of drug release and bioadhesive characteristics.

The current study involves development of oral bioadhesive hydrophilic matrices of hydralazine hydrochloride, and optimization of their in vitro drug release profile and ex vivo bioadhesion against porcine gastric mucosa. A 32 central composite design was employed to systematically optimize the drug delivery formulations containing two polymers, viz., carbomer and hydroxypropyl methyl cellulose. Response surface plots were drawn and optimum formulations were selected by brute force searches. Validation of the formulation optimization study indicated a very high degree of prognostic ability. The study successfully undertook the development of an optimized once-a-day formulation of hydralazine with excellent bioadhesive and controlled release characteristics.

Biobleaching of wheat straw-rich soda pulp with alkalophilic laccase from gamma-proteobacterium JB: optimization of process parameters using response surface methodology.

An alkalophilic laccase from gamma-proteobacterium JB was applied to wheat straw-rich soda pulp to check its bleaching potential by using response surface methodology based on central composite design. The design was employed by selecting laccase units, ABTS (2,2'-azino-bis (3-ethylbenzothiazoline-6-sulfonic acid)) concentration and pH as model factors. The results of second order factorial design experiments showed that all three independent variables had significant effect on brightness and kappa number of laccase-treated pulp. Optimum conditions for biobleaching of pulp with laccase preparation (specific activity, 65 nkat mg(-1) protein) were 20 nkat g(-1) of pulp, 2mM ABTS and pH 8.0 which enhanced brightness by 5.89% and reduced kappa number by 21.1% within 4h of incubation at 55 degrees C, without further alkaline extraction of pulp. Tear index (8%) and burst index (18%) also improved for laccase-treated pulp as compared to control raw pulp. Treatment of chemically (CEH1H2) bleached pulp with laccase showed significant effect on release of chromophores, hydrophobic and reducing compounds. Laccase-prebleaching of raw pulp reduced the use of hypochlorite by 10% to achieve brightness of resultant hand sheets similar to the fully chemically bleached pulp.

Studies on dissolution enhancement and mathematical modeling of drug release of a poorly water-soluble drug using water-soluble carriers.

Role of various water-soluble carriers was studied for dissolution enhancement of a poorly soluble model drug, rofecoxib, using solid dispersion approach. Diverse carriers viz. polyethylene glycols (PEG 4000 and 6000), polyglycolized fatty acid ester (Gelucire 44/14), polyvinylpyrollidone K25 (PVP), poloxamers (Lutrol F127 and F68), polyols (mannitol, sorbitol), organic acid (citric acid) and hydrotropes (urea, nicotinamide) were investigated for the purpose. Phase-solubility studies revealed AL type of curves for each carrier, indicating linear increase in drug solubility with carrier concentration. The sign and magnitude of the thermodynamic parameter, Gibbs free energy of transfer, indicated spontaneity of solubilization process. All the solid dispersions showed dissolution improvement vis-à-vis pure drug to varying degrees, with citric acid, PVP and poloxamers as the most promising carriers. Mathematical modeling of in vitro dissolution data indicated the best fitting with Korsemeyer-Peppas model and the drug release kinetics primarily as Fickian diffusion. Solid state characterization of the drug-poloxamer binary system using XRD, FTIR, DSC and SEM techniques revealed distinct loss of drug crystallinity in the formulation, ostensibly accounting for enhancement in dissolution rate.

Formulation and optimization of controlled release mucoadhesive tablets of atenolol using response surface methodology.

The aim of the current study was to design oral controlled release mucoadhesive compressed hydrophilic matrices of atenolol and to optimize the drug release profile and bioadhesion using response surface methodology. Tablets were prepared by direct compression and evaluated for bioadhesive strength and in vitro dissolution parameters. A central composite design for 2 factors at 3 levels each was employed to systematically optimize drug release profile and bioadhesive strength. Carbopol 934P and sodium carboxymethylcellulose were taken as the independent variables. Response surface plots and contour plots were drawn, and optimum formulations were selected by feasibility and grid searches. Compressed matrices exhibited non-Fickian drug release kinetics approaching zero-order, as the value of release rate exponent (n) varied between 0.6672 and 0.8646, resulting in regulated and complete release until 24 hours. Both the polymers had significant effect on the bioadhesive strength of the tablets, measured as force of detachment against porcine gastric mucosa (P < .001). Polynomial mathematical models, generated for various response variables using multiple linear regression analysis, were found to be statistically significant (P < .01). Validation of optimization study, performed using 8 confirmatory runs, indicated very high degree of prognostic ability of response surface methodology, with mean percentage error (+/- SD) as -0.0072 +/- 1.087. Besides unraveling the effect of the 2 factors on the various response variables, the study helped in finding the optimum formulation with excellent bioadhesive strength and controlled release.

Formulation and optimization of controlled release mucoadhesive tablets of atenolol using response surface methodology.

The aim of the current study was to design oral controlled release mucoadhesive compressed hydrophilic matrices of atenolol and to optimize the drug release profile and bioadhesion using response surface methodology. Tablets were prepared by direct compression and evaluated for bioadhesive strength and in vitro dissolution parameters. A central composite design for 2 factors at 3 levels each was employed to systematically optimize drug release profile and bioadhesive strength. Carbopol 934P and sodium carboxymethylcellulose were taken as the independent variables. Response surface plots and contour plots were drawn, and optimum formulations were selected by feasibility and grid searches. Compressed matrices exhibited non-Fickian drug release kinetics approaching zero-order, as the value of release rate exponent (n) varied between 0.6672 and 0.8646, resulting in regulated and complete release until 24 hours. Both the polymers had significant effect on the bioadhesive strength of the tablets, measured as force of detachment against porcine gastric mucosa (P<.001). Polynomial mathematical models, generated for various response variables using multiple linear regression analysis, were found to be statistically significant (P<.01). Validation of optimization study, performed using 8 confirmatory runs, indicated very high degree of prognostic ability of response surface methodology, with mean percentage error (±SD) as -0.0072±1.087. Besides unraveling the effect of the 2 factors on the various response variables, the study helped in finding the optimum formulation with excellent bioadhesive strength and controlled release.

Design, development and optimization of nimesulide-loaded liposomal systems for topical application.

Nimesulide, a non-steroidal anti-inflammatory drug, was incorporated into multilamellar liposomes to improve its performance on topical administration. The drug was loaded onto liposomes employing thin film hydration technique. Various process and formulation variables were investigated to obtain the liposomal products of desired quality. Liposomes were monitored for percent drug entrapment, after separating the unentrapped drug by mini column centrifugation, for vesicular properties (such as size distribution profile, morphological attributes and agglomeration tendency), drug diffused through synthetic semipermeable membrane, and drug leakage. Systematic optimization studies were carried out using 3(2) factorial design to select the optimized liposomal composition with reference to percent drug entrapment, drug diffusion and leakage. The optimized batch of liposomes was subjected to drug permeation and drug retention studies employing rat skin and human cadaver skin. In comparison to methanolic solution of pure nimesulide, liposomal formulations were found to retain higher amounts of nimesulide in the skin. Anti-inflammatory studies, using carragenan-induced rat paw edema model, indicated significantly better performance of liposomally entrapped nimesulide in comparison to the marketed gel formulation and the Carbopol gel containing nimesulide.

Optimizing drug delivery systems using systematic "design of experiments." Part II: retrospect and prospects.

The first study on application of Design of Experiments (DoE) in optimizing drug formulation appeared in 1967. Since then the number of literature reports on the use of DoE optimization in development of drug delivery technologies has been piling up steadily. Such systematic techniques find their use in every type of conventional dosage form and modern drug delivery system. The drug delivery devices investigated for optimization using response surface methodology include controlled release compressed matrices, microparticulates, macroparticulates, vesicular systems, floating systems, bioadhesive systems, semisolids, transdermals, and inhalations. The optimized processes mainly include extrusion-spheronization, pelletization, microencapsulation, coating, granulation, and tableting. Part I of this article [Crit Rev Ther Drug Carrier Syst 2005; 22(1):27-106] dealt with the salient steps involved in the DoE optimization methodology using diverse experimental designs. Part II deals with various retrospective literature findings as well as the prospective application of such DoE procedures while optimizing varied drug delivery technologies. A vast account of various DoE reports on optimization of diverse drug delivery system and processes along with the critical graphical analysis of various designs, input, and response variables have been presented here in a categorical form. Such an explicit and updated review on drug delivery optimization has not been published anywhere else in the recent past.

Optimizing drug delivery systems using systematic "design of experiments." Part I: fundamental aspects.

Design of an impeccable drug delivery product normally encompasses multiple objectives. For decades, this task has been attempted through trial and error, supplemented with the previous experience, knowledge, and wisdom of the formulator. Optimization of a pharmaceutical formulation or process using this traditional approach involves changing one variable at a time. Using this methodology, the solution of a specific problematic formulation characteristic can certainly be achieved, but attainment of the true optimal composition is never guaranteed. And for improvement in one characteristic, one has to trade off for degeneration in another. This customary approach of developing a drug product or process has been proved to be not only uneconomical in terms of time, money, and effort, but also unfavorable to fix errors, unpredictable, and at times even unsuccessful. On the other hand, the modern formulation optimization approaches, employing systematic Design of Experiments (DoE), are extensively practiced in the development of diverse kinds of drug delivery devices to improve such irregularities. Such systematic approaches are far more advantageous, because they require fewer experiments to achieve an optimum formulation, make problem tracing and rectification quite easier, reveal drug/polymer interactions, simulate the product performance, and comprehend the process to assist in better formulation development and subsequent scale-up. Optimization techniques using DoE represent effective and cost-effective analytical tools to yield the "best solution" to a particular "problem." Through quantification of drug delivery systems, these approaches provide a depth of understanding as well as an ability to explore and defend ranges for formulation factors, where experimentation is completed before optimization is attempted. The key elements of a DoE optimization methodology encompass planning the study objectives, screening of influential variables, experimental designs, postulation of mathematical models for various chosen response characteristics, fitting experimental data into these model(s), mapping and generating graphic outcomes, and design validation using model-based response surface methodology. The broad topic of DoE optimization methodology is covered in two parts. Part I of the review attempts to provide thought-through and thorough information on diverse DoE aspects organized in a seven-step sequence. Besides dealing with basic DoE terminology for the novice, the article covers the niceties of several important experimental designs, mathematical models, and optimum search techniques using numeric and graphical methods, with special emphasis on computer-based approaches, artificial neural networks, and judicious selection of designs and models.

Fritz de Quervain, MD (1868-1940): stenosing tendovaginitis at the radial styloid process.

Fritz de Quervain was the first surgeon to describe and treat chronic stenosing tendovaginitis at the radial styloid process. The current management of this condition differs little from his initial description and as a result the condition now bears his name. He and his mentor, Nobel Prize winner Theodor Kocher, advanced the understanding and treatment of thyroid disease, especially subacute nonsuppurative thyroiditis, another condition to which his name is attached. He was a pioneer of surgical technology and author of books and articles read worldwide and is largely responsible for the introduction of iodized table salt.

Rofecoxib: an update on physicochemical, pharmaceutical, pharmacodynamic and pharmacokinetic aspects.

Rofecoxib (MK-966) is a new generation non-steroidal anti-inflammatory agent (NSAID) that exhibits promising anti-inflammatory, analgesic and antipyretic activity. It selectively inhibits cyclooxygenase (COX)-2 isoenzyme in a dose-dependent manner in man. No significant inhibition of COX-1 is observed with rofecoxib up to doses of 1000 mg. The pharmacokinetics of rofecoxib has been found to be complex and variable. Mean oral bioavailability after single dose of rofecoxib (12.5, 25 or 50 mg) is 93% with t(max) varying widely between 2 and 9 h. It is highly plasma-protein bound and is metabolized primarily by cytosolic reductases to inactive metabolites. Rofecoxib is eliminated predominantly by hepatic metabolism with a terminal half-life of approximately 17 h during steady state. Various experimental models and clinical studies have demonstrated rofecoxib to be superior, or at least equivalent, in anti-inflammatory, analgesic and antipyretic efficacy to comparator nonselective NSAIDs in osteoarthritis, rheumatoid arthritis and other pain models. Emerging evidence suggests that rofecoxib may also find potential use as supportive therapy in various pathophysiologic conditions like Alzheimer's disease, and in various malignant tumours and polyps, where COX-2 is overly expressed. Rofecoxib is generally well-tolerated. Analysis of data pooled from several trials suggests that rofecoxib is associated with fewer incidences of clinically symptomatic gastrointestinal ulcers and ulcer complications vis-à-vis conventional NSAIDs. However, this gastropreserving effect may be negated by concurrent use of low-dose aspirin for cardiovascular risk reduction. Rofecoxib tends to show similar tolerability for renal and cardiothrombotic events as compared with nonnaproxen nonselective NSAIDs. No clinically significant drug interaction has been reported for rofecoxib except with diuretics, where it reverses their salt-wasting effect and thus can be clinically exploited in electrolyte-wasting disorders. There is only modest information about the physicochemical and pharmaceutical aspects of rofecoxib. Being poorly water soluble, its drug delivery has been improved using varied formulation approaches. Although it is stable in solid state, rofecoxib is photosensitive and base-sensitive in solution form with its degradation mechanistics elucidated. Analytical determinations of rofecoxib and its metabolites in biological fluids employing HPLC with varied types of detectors have been reported. Isolated studies have also been published on the chromatographic and spectrophotometric assay of rofecoxib and its degradants in bulk samples and pharmaceutical dosage forms. The current article provides an updated overview on the physicochemical, pharmaceutical, pharmacokinetic and pharmacodynamic vistas of rofecoxib.