Guggulu (Commiphora mukul) is about 2-3.5 mt heighted plant of Burceraceae family. The plant grows wild in the arid, rocky tracts, also in low rainy and hot areas. The part used in medicinal preparation is resin, collected by tapping the barks. Guggulu deserves high values in Ayurvedic medicines. Guggulu is Rasayana, Vatakaphaghna, and used in various diseases. Due to high values and excessive demands, improper methods of collection, uncontrolled forest destruction and poor knowledge of cultivation; number of plants highly decreased. Now it categorized as threatened plant. Hence cultivation and conservation of this plant is necessary. Guggulu can be propagated by seed and vegetative method. Germination through seed is very poor. Vegetative propagation through stem cutting is most common and successful method. Farming care is also necessary f or proper growth. Conservation can be effected by knowledge of collection methods and awareness.
Commiphora mukul; tapping; cultivation; Germination; Vegetative propagation; Conservation
This study was conducted to estimate the heavy metal profile and determine the safety of Mahayograj guggulu, an Ayurvedic herbo-mineral preparation.
Mahayograj guggulu, manufactured by Shree Baidynath Ayurved Bhawan Pvt. Ltd., Gwalior Road, Jhansi - 284 003 (of batch number-07 and manufacturing date October 2004) was procured from the local market. Heavy metal concentrations were measured using an atomic absorption spectrophotometer. A total of 40 Charles Foster strain albino rats of either sex with an average body weight of 160–250 g were divided into four groups (Groups I, II, III and IV), with 10 animals in each group. Group I served as the control, while Group II, III and IV rats received Mahayograj guggulu at a dose of 54 (dose equivalent to human therapeutic dose), 270 (five-times the dose equivalent to the human therapeutic dose) and 540 (10-times the dose equivalent to human therapeutic dose) mg/kg, p.o. for 120 days. The effect of drug administration was noted on the ponderal, biochemical, hematological and histopathological parameters. In addition, urine examination was also carried out. At the end of the study, only six rats per group were sacrificed as per the IAEC advice.
Mahayograj guggulu was found to be safe at all dose levels tested. No significant behavioral changes were noted in any of the groups studied. The effect on food and water consumption and fecal and urine output remained unaffected in all groups during the study period. No major alterations were observed in hematology, serum biochemistry, necropsy and histopathology at the therapeutically advocated dose level. Heavy metal content measurement indicated levels of 25.8 µg/g for lead, 0.07 µg/g for mercury and 5.19 µg/g for arsenic.
The test drug is well tolerated as no changes of a serious nature could be observed in any of the parameters assessed.
Heavy metal content; Mahayograj guggulu; safety; toxicity
In the present study, an attempt was made to prepare immediate-release enteric-coated pellets of aceclofenac, a poorly soluble nonsteroidal anti-inflammatory drug that has a gastrointestinal intolerance as its serious side effect. Formulation of enteric-coated pellets with improved solubility of aceclofenac could address both of these problems. To achieve these goals, pellets were prepared by extrusion–spheronization method using pelletizing agents that can contribute to the faster disintegration and thereby improve the solubility of the drug. Different disintegrants like β-cyclodextrin, kollidon CL, Ac-Di-Sol, and sodium starch glycolate were tried in order to further improve disintegration time. The pellets were characterized for drug content, particle size distribution, flow properties, infrared spectroscopy, surface morphology, disintegration rate, and dissolution profile. The formulations, which showed best disintegration and dissolution profiles, were coated with Eudragit L100-55, an enteric-coated polymer which does not dissolve at gastric pH but dissolves at intestinal pH, releasing the drug immediately in the dissolution medium. The optimized enteric-coated formulation containing 20% κ-carrageenan, lactose, and sodium starch glycolate as a disintegrant did inhibit the release of the drug for 2 h in 0.1 N HCl, whereas 87% of the drug was released within 45 min. The improvement was substantial when it was compared with solubility of pure drug under the same conditions. Thus, dissolution profiles suggested that combination of κ-carrageenan and sodium starch glycolate resulted into fast-disintegrating, immediate-release pellets, overcoming the bioavailability problem of the poorly soluble drug, aceclofenac, and enteric coating of these pellets avoids the exposure of aceclofenac to ulcer-prone areas of the gastrointestinal tract.
aceclofenac; enteric-coated; κ-carrageenan; pellets
Mouth dissolving tablets constitute an innovative dosage form that overcomes the problems of swallowing and provides a quick onset of action. In view of enhancing bioavailability an attempt has been made to study two different methods direct compression and sublimation in formulation of mouth dissolving tablets of clozapine. Total four formulations using various superdisintegrants and subliming agents were prepared. All prepared formulations were evaluated for physico-chemical parameters. The formulations exhibited good disintegration properties with total disintegration time in the range of 25 to 35 s. Comparative evaluation of two methods showed direct compression method is a better alternative to sublimation method as its formulations rapidly disintegrate in oral cavity. In vitro cumulative percentage drug release for formulations prepared by direct compression with explotab superdisintegrants shows 99.79 while sublimation method using camphor 93.58 release in 12 min. Kinetic studies indicated that all the formulations followed first order release with diffusion mechanism.
Clozapine; direct compression; sublimation; mouth dissolving
The aim of this paper was to study the effect of the granulate properties and tablet compression force on disintegrating force behavior in order to investigate the capability of the disintegrating force to characterize tablets that have the same composition but were manufactured in different conditions. Several tablets containing spironolactone in the external or internal granulated mixture of calcium carbonate and maize starch differing in particle size distribution, were prepared at 3 compression levels. The force developed by tablets during water uptake and disintegration was measured and plotted versus time. The curves obtained were analyzed by the Weibull equation in order to calculate the parameters characterizing the tablet disintegration kinetics. The disintegrating force time parameter, the maximum force developed, and the area under the curve were determined. In general, the reduction of time parameter value and/or the increase in maximum force developed corresponded to an acceleration in tablet disintegration. In addition, the area under the force curve increased in stronger tablets, monitoring in a sensitive way the tablet structural changes introduced by compression force. The results showed that the disintegrating force measurement can detect small changes in the structure of the tablet that cannot be discriminated by pharmacopoeia tests. The effect of manufacturing, in particular compression force, on tablet properties was quantified by the parameters of disintegrating force kinetics.
disintegrating force; spironolactone; tablet; granulation; compression force
The aim of this study was to evaluate the influence of disintegration mechanism of various types of disintegrants on the absorption ratio (AR), wetting time (WT), and disintegration time (DT) of orodispersible tablets (ODTs). ODTs were prepared by direct compression using mannitol as filler and disintegrants selected from a range of swellable, osmotic, and porous disintegrants. Tablets formed were characterized for their water AR, WT, and DT. The porosity and mechanical strength of the tablets were also measured. Results show that the DT of formulated ODTs was directly related to the WT and was a function of the disintegration mechanism of the disintegrant used. The lowest WT and DT were observed for tablets formulated using the osmotic disintegrant sodium citrate and these tablets also showed the lowest AR and porosity. The wetting and disintegration of tablets containing the highly swellable disintegrant, sodium starch glycollate, was slowest despite their high water AR and high tablet porosity. Rapid wetting and disintegration of ODTs were therefore not necessarily related to the porosity of the tablets.
Absorption ratio; disintegration time; orodispersible tablets; porosity; wetting time
The present study was aimed to assess the clinical effectiveness of Rasona Rasnadi Ghanavati and Simhanada Guggulu along with Rasona Rasnadi Lepa in Amavata, and to compare the effect of these two therapies in the treatment. Total 101 patients of Amavata were registered for the present study and were randomly divided into two groups. In group A- Rasona Rasnadi Ghanavati 2 Vati thrice/day was given for 3 months, while in group B- Simhanada Guggulu 2 Vati thrice a day for 3 months was adminstered. Along with this, Rasona Rasnadi Lepa was applied locally over affected joints twice daily in both groups. The effects of therapy in both groups were assessed by a specially prepared proforma. The results of the study showed that both the groups showed significant relief in symptoms; however, compared to Simhanada Guggulu, Rasona Rasnadi Ghanavati showed better result in the management of Amavata. Simhanada Guggulu or Rasona Rasnadi Ghanavati along with Rasona Rasnadi Lepa can be used as an effective ayurvedic intervention in the treatment for rheumatoid arthritis.
Ama; Amavata; Rasona Rasnadi Ghanavati; Rheumatoid arthritis; Simhanada Guggulu; Vata
Diabetic nephropathy is a specific form of renal disease. It is a major cause of renal insufficiency and ultimately of death. The present study has been carried out to prove the efficacy of Ayurvedic drugs in the management of diabetic nephropathy, which can be helpful in reducing the need of dialysis and avoiding or delaying renal transplantation. A total of 130 patients of this disease were treated in IPD (Group A) and OPD (Group B). Ayurvedic formulations including Gokshuradi Guggulu, Bhumyamalaki, Vasa and Shilajatvadi Vati were given to all the patients for 2 months. Group A patients were given special planned food. Results were analyzed statistically using “t” test. In group A patients, highly significant reduction was found in the values of serum creatinine, blood urea and urinary excretion of albumin. Marked improvement was found in the patients’ general physical well-being, together with reduction in symptoms, in group A patients. This shows the importance of Pathyapathya in Ayurvedic management of the disease. This management may bring some new hope to the patients of diabetic nephropathy, which usually terminates to chronic renal failure and ultimately to death. Further studies are being carried out in this regard.
Ayurveda; diabetic nephropathy; albuminuria
Abha Guggulu an Ayurvedic medicine was tried clinically on 15 patients having simple fractures. The duration of the treatment varied from 13 to 40 days, depending on several factors, Radiological tests were conducted periodically during the administration of the medicine. The patients were examined clinically every day to assess the effect of the medicine on the healing process, the medicine was found to bring about significant anti-inflammatory effects, relief in symptoms and positive aspects of improvement in blood picture ultimately culminating in the healing of fractures. Thus this medicine is recommended for the treatment of simple fractures.
Sandhigatavata is described under vatavyadhi in all ayurvedic classical texts. Osteoarthritis is the most common articular disorder which begins asymptomatically in the second and third decades and is extremely common by age 70. Here Matra Vasti (therapeutic enema) was given with Bala taila as Vasti is the best treatment for vatavyadhies. It has vatashamaka and rasayana properties. Indigenous compound drug containing Guggulu, Shallaki, Yastimadhu, Pippali, Guduchi, Nirgundi, Kupilu and Godanti was given in one group along with Matra Vasti. In this study, 33 patients of Sandhigatavata completed the treatment. Patients were randomly divided into two groups. Sixteen patients in Group-A (sarvanga Abhyanga-swedana + matravasti) and 17 patients in Group-B (sarvanga Abhyanga–swedana+ matravasti + indigenous compound drug). The results of the study indicate that the patients of both the groups obtained highly significant relief in almost all the signs and symptoms of Sandhigatavata.
Abhyanga; indigenous compound drug; Matra Vasti; osteoarthritis; Sandhigatavata; swedana; vatavyadhi; therapeutic enema.
The recent challenge in orally disintegrating tablets (ODT) manufacturing encompasses the compromise between instantaneous disintegration, sufficient hardness, and standard processing equipment. The current investigation constitutes one attempt to fulfill this challenge. Maltodextrin, in the present work, was utilized as a novel excipient to prepare ODT of meclizine. Tablets were prepared by both direct compression and wet granulation techniques. The effect of maltodextrin concentrations on ODT characteristics—manifested as hardness and disintegration time—was studied. The effect of conditioning (40°C and 75% relative humidity) as a post-compression treatment on ODT characteristics was also assessed. Furthermore, maltodextrin-pronounced hardening effect was investigated using differential scanning calorimetry (DSC) and X-ray analysis. Results revealed that in both techniques, rapid disintegration (30–40 s) would be achieved on the cost of tablet hardness (about 1 kg). Post-compression conditioning of tablets resulted in an increase in hardness (3 kg), while keeping rapid disintegration (30–40 s) according to guidance of the FDA for ODT. However, direct compression-conditioning technique exhibited drawbacks of long conditioning time and appearance of the so-called patch effect. These problems were, yet, absent in wet granulation-conditioning technique. DSC and X-ray analysis suggested involvement of glass-elastic deformation in maltodextrin hardening effect. High-performance liquid chromatography analysis of meclizine ODT suggested no degradation of the drug by the applied conditions of temperature and humidity. Overall results proposed that maltodextrin is a promising saccharide for production of ODT with accepted hardness-disintegration time compromise, utilizing standard processing equipment and phenomena of phase transition.
disintegration time; maltodextrin; meclizine; orally disintegrating tablets; phase transition
Aceclofenac, a non-steroidal antiinflammatory drug, is used for posttraumatic pain and rheumatoid arthritis. Aceclofenac fast-dispersible tablets have been prepared by direct compression method. Effect of superdisintegrants (such as, croscarmellose sodium, sodium starch glycolate and crospovidone) on wetting time, disintegration time, drug content, in vitro release and stability parameters has been studied. Disintegration time and dissolution parameters (t50% and t80%) decreased with increase in the level of croscarmellose sodium. Where as, disintegration time and dissolution parameters increased with increase in the level of sodium starch glycolate in tablets. However, the disintegration time values did not reflect in the dissolution parameter values of crospovidone tablets and release was dependent on the aggregate size in the dissolution medium. Stability studies indicated that tablets containing superdisintegrants were sensitive to high humidity conditions. It is concluded that fast-dispersible aceclofenac tablets could be prepared by direct compression using superdisintegrants.
Fast dispersible tablets; aceclofenac; croscarmellose sodium; sodium starch glycolate; crospovidone; disintegration time; dissolution
The purpose of the present investigation was to increase the solubility and dissolution rate of rofecoxib by the preparation of its solid dispersion with polyvinyl pyrrolidone K30 (PVP K30) using solvent evaporation method. Drug-polymer interactions were investigated using differential scanning calorimetry (DSC), x-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FTIR). For the preparation of rofecoxib mouth dissolve tablets, its 1∶9 solid dispersion with PVP K30 was used with various disintegrants and sublimable materials. In an attempt to construct a statistical model for the prediction of disintegration time and percentage friability, a 32 randomized full and reduced factorial design was used to optimize the influence of the amounts of superdisintegrant and subliming agent. The obtained results showed that dispersion of the drug in the polymer considerably enhanced the dissolution rate. The drug-to-carrier ratio was the controlling factor for dissolution improvement. FTIR spectra revealed no chemical incompatibility between the drug and PVP K30. As indicated from XRD and DSC data, rofecoxib was in the amorphous form, which explains the better dissolution rate of the drug from its solid dispersions. Concerning the optimization study, the multiple regression analysis revealed that an optimum concentration of camphor and a higher percentage of crospovidone are required for obtaining rapidly disintegrating tablets. In conclusion, this investigation demonstrated the potential of experimental design in understanding the effect of the formulation variables on the quality of mouth dissolve tablets containing solid dispersion of a hydrophobic drug.
rofecoxib; polyvinyl pyrrolidone K30; solid dispersion; solvent method; mouth dissolve tablets; factorial design
The penetration into HeLa cells of Toxoplasma gondii was studied with a cell culture technique. The influence on the rate of penetration and the number of penetrating Toxoplasma parasites was tested by use of preparations of disintegrated parasites mixed with test parasites. These preparations were found to contain factors enhancing the penetrating rate of the parasites. This effect was demonstrable by use of untreated parasites as well as parasites lacking active motility owing to a previous exposure to Formalin. The preparations of disintegrated parasites contained, in addition, components inhibitory to the penetration-enhancing factors. These inhibitory components were able to reduce the penetrating capacity of normal Toxoplasma parasites, suggesting that the studied enhancing factors may play a role in the natural process of penetration. The efficacy of various techniques for disintegration of Toxoplasma parasites was investigated for release of penetration-enhancing factors from Toxoplasma parasites. The methods used resemble those used for liberation of lysosomal enzymes. Reduced osmotic pressure was obviously not adequate for release of enhancing factors, whereas the freezing and thawing procedure, sonic treatment, and irradiation produced high yields. It was difficult to evaluate the effect of incubation at acid pH on release of enhancing activity, because the penetration-promoting factors seemed unstable on both the acid and the alkaline sides of pH 7.6.
The purpose of this research was to develop mouth dissolve tablets of nimesulide. Granules containing nimesulide, camphor, crospovidone, and lactose were prepared by wet granulation technique. Camphor was sublimed from the dried granules by exposure to vacuum. The porous granules were then compressed. Alternatively, tablets were first prepared percentage friability, wetting time, and disintegration time. In the investigation, a 32 full factorial design was used to investigate the joint influence of 2 formulation variables: amount of camphor and crospovidone. The results of multiple linear regression analysis revealed that for obtaining a rapidly disintegrating dosage form, tablets should be prepared using an optimum concentration of camphor and a higher percentage of crospovidone. A contour plot is also presented to graphically represent the effect of the independent variables on the disintegration time and percentage friability. A checkpoint batch was also prepared to prove the validity of the evolved mathematical model. Sublimation of camphor from tablets resulted in superior tablets as compared with the tablets prepared from granules that were exposed to vacuum. The systematic formulation approach helped in understanding the effect of formulation processing variables.
mouth dissolve tablet; nimesulide; camphor; factorial design; contour plot
The purpose of this research was to improve the hygrpscopicity and poor flow properties of the crude dry extract of the seeds of Glinus lotoides and improve the disintegration time of the core-tablets for enteric coated formulation thereof. The liquid crude extract of the plant was adsorbed on granulated colloidal silicon dioxide (Aeroperl® 300 Pharma) at 30% w/w and the dry extract preparation (DEP) was dry-granulated with roller-compaction using Micro-Pactor®. Hygroscopicity, flow property and disintegration time were improved significantly due to the adsorption and granulation processes. Moreover, the DEP does not become mucilaginous even at higher relative humidity levels (above 65%). Oblong tablets (20 × 8.25 mm) containing 947 mg of the granulated DEP (equivalent to the traditional dose), 363 mg of Avicel® PH101 and 90 mg of Ac-di-Sol® as disintegrant were formulated using an instrumented eccentric tablet machine at 20 kN. The tablets showed a crushing strength of 195 N, a friability of 0.4% and disintegrated within 9 min. The tablets were then enteric coated using polymethacrylate co-polymers (Eudragit® L 100-55 and Kollicoat® MAE 100P). The coated tablets resisted disintegration or softening in simulated gastric fluid for a minimum of 2 h and disintegrated within 15 min in intestine simulated fluid at pH 6.8. In addition to controlling the release of the active agents, the enteric coating improved the strength and decreased friability of the core-tablets.
Aeroperl® 300 Pharma; dry granulation; enteric coated; Glinus lotoides; phytopharmaceutical
The purpose of this research was to obtain directly compressible agglomerates of naproxen containing disintegrant by spherical crystallization technique. Acetone–water containing hydroxypropyl celloluse (HPC) and disintegrant was used as the crystallization system. In this study croscarmellose sodium (Ac–Di–Sol) was employed as disintegrant. The agglomerates were characterized by differential scanning calorimetry (DSC), powder X-ray diffraction (XRPD), and scanning electron microscopy and were evaluated for flow, packing and tableting properties and drug release. The growth of particle size and the spherical form of the agglomerates resulted in formation of products with good flow and packing properties. The improved compaction properties of the agglomerated crystals were due to their fragmentation occurred during compression. DSC and XRPD studies showed that naproxen particles, crystallized in the presence of HPC and Ac–Di–Sol did not undergo structural modifications. The dissolution rate of naproxen from tablets made of naproxen–(Ac–Di–Sol) agglomerates was enhanced significantly because of including the disintegrant in to the particles. This was attributed to an increase in the surface area of the practically water insoluble drug is exposed to the dissolution medium. In conclusion the spherical crystallization technique developed in this study is suitable for obtaining agglomerates of drug with disintegrant.
direct tableting; disintegration; naproxen; spherical crystallization
Rheumatic disorders like Amavata, Sandhivata and Vatarakta are elaborately described in ayurvedic literature. Preliminary survey of literature shows that about 247 formulations are recommended for these rheumatic disorders. These formulations generally include guggulu compounds, compounds of plant powders, decoctions, medicated ghees, oils, electuaries etc. Therapeutic potential of ayurvedic concepts and a brief review of Ayurvedic formulations are also discussed.
Taste masked microspheres of ornidazole were prepared using amino alkyl methacrylate copolymers (Eudragit E-100) by solvent evaporation technique. Taste assessment of these microspheres was done by both spectrophotometric taste evaluation technique and panel testing. Compressed tablets of taste masked ornidazole microspheres which rapidly disintegrated in the oral cavity were prepared using microcrystalline cellulose as directly compressible filler and sodium starch glycolate as a super-disintegrant. These were subsequently evaluated for various pharmacopoeial tests, drug release, and disintegration time in the oral cavity. Sensory taste evaluation was carried by panel testing in 20 healthy human volunteers. Results indicate successful formulation of oral fast disintegrating tablets which disintegrated in the oral cavity in about 30 s and possessed good taste.
Eudragit E-100; fast disintegrating tablets; microspheres; ornidazole; taste masking
Aim of the Study:
Development of standardized, synergistic, safe and effective traditional herbal formulations with robust scientific evidence can offer faster and more economical alternatives for the treatment of disease. The main objective was to develop a method of preparation of guggulkalpa tablets so that the tablets meet the criteria of efficacy, stability, and safety.
Materials and Methods:
Triphalaguggulkalpa tablet, described in sharangdharsanhita and containing guggul and triphala powder, was used as a model drug. Preliminary experiments on marketed triphalaguggulkalpa tablets exhibited delayed in vitro disintegration that indicated probable delayed in vivo disintegration. The study involved preparation of triphalaguggulkalpa tablets by Ayurvedic text methods and by wet granulation, dry granulation, and direct compression method. The tablets were evaluated for loss on drying, volatile oil content, % solubility, and steroidal content. The tablets were evaluated for performance tests like weight variation, disintegration, and hardness.
It was observed that triphalaguggulkalpa tablets, prepared by direct compression method, complied with the hardness and disintegration tests, whereas tablets prepared by Ayurvedic text methods failed.
Direct compression is the best method of preparing triphalaguggulkalpa tablets.
Ayurveda; guggulkalpa tablets; gutikas; quality control; triphala
Amavata is the second most common joint disorders. Nowadays erroneous dietary habits, lifestyle and environment have led to various autoimmune disorders i.e. Amavisajanya Vikaara and Amavata is one among them. Rheumatoid arthritis can be correlated with Amavata in view of its clinical features. Many research studies have been done to solve this clinical enigma, but an effective, safe, less complicated treatment is still required for the management of Amavata. In the present study, 24 patients of Amavata were registered and randomly grouped into two. In group A, Shiva Guggulu 6 g/day in divided doses and in group B, Simhanada Guggulu 6 g/day in divided doses were given for 8 weeks. On analysis of the results, it was found that Simhanada Guggulu provided better results as compared to Shiva Guggulu in the management of Amavata.
Agni; Ama; Amavata; rheumatoid arthritis; Shiva Guggulu; Simhanada Guggulu
The purpose of the work was to investigate correlation between disintegration and dissolution for immediate release tablets containing a high solubility drug and to identify formulations where disintegration test, instead of the dissolution test, may be used as the acceptance criteria based on International Conference on Harmonization Q6A guidelines. A statistical design of experiments was used to study the effect of filler, binder, disintegrating agent, and tablet hardness on the disintegration and dissolution of verapamil hydrochloride tablets. All formulation variables, i.e., filler, binder, and disintegrating agent, were found to influence tablet dissolution and disintegration, with the filler and disintegrating agent exerting the most significant influence. Slower dissolution was observed with increasing disintegration time when either the filler or the disintegrating agent was kept constant. However, no direct corelationship was observed between the disintegration and dissolution across all formulations due to the interactions between different formulation components. Although all tablets containing sodium carboxymethyl cellulose as the disintegrating agent, disintegrated in less than 3 min, half of them failed to meet the US Pharmacopeia 30 dissolution criteria for the verapamil hydrochloride tablets highlighting the dependence of dissolution process on the formulation components other than the disintegrating agent. The results identified only one formulation as suitable for using the disintegration test, instead of the dissolution test, as drug product acceptance criteria and highlight the need for systematic studies before using the disintegration test, instead of the dissolution test as the drug acceptance criteria.
disintegration test; dissolution test; ICH Q6A; specification
The purpose of this investigation was to develop fast dissolving tablets of etoricoxib. Granules containing etoricoxib, menthol, crospovidone, aspartame and mannitol were prepared by wet granulation technique. Menthol was sublimed from the granules by exposing the granules to vacuum. The porous granules were then compressed in to tablets. Alternatively, tablets were first prepared and later exposed to vacuum. The tablets were evaluated for percentage friability and disintegration time. A 32 full factorial design was applied to investigate the combined effect of 2 formulation variables: amount of menthol and crospovidone. The results of multiple regression analysis indicated that for obtaining fast dissolving tablets; optimum amount of menthol and higher percentage of crospovidone should be used. A surface response plots are also presented to graphically represent the effect of the independent variables on the percentage friability and disintegration time. The validity of a generated mathematical model was tested by preparing a checkpoint batch. Sublimation of menthol from tablets resulted in rapid disintegration as compared with the tablets prepared from granules that were exposed to vacuum. The optimized tablet formulation was compared with conventional marketed tablets for percentage drug dissolved in 30 min (Q30) and dissolution efficiency after 30 min (DE30). From the results, it was concluded that fast dissolving tablets with improved etoricoxib dissolution could be prepared by sublimation of tablets containing suitable subliming agent.
Fast dissolving tablets; etoricoxib; sublimation; menthol; factorial design; response surface plot
Current adherence assessments typically detect missed doses long after they occur. Real-time, wireless monitoring strategies for antiretroviral therapy may provide novel opportunities to proactively prevent virologic rebound and treatment failure. Wisepill, a wireless pill container that transmits a cellular signal when opened, was pilot tested in ten Ugandan individuals for 6 months. Adherence levels measured by Wisepill, unannounced pill counts, and self-report were compared with each other, prior standard electronic monitoring, and HIV RNA. Wisepill data was initially limited by battery life and signal transmission interruptions. Following device improvements, continuous data was achieved with median (interquartile range) adherence levels of 93% (87–97%) by Wisepill, 100% (99–100%) by unannounced pill count, 100% (100–100%) by self-report, and 92% (79–98%) by prior standard electronic monitoring. Four individuals developed transient, low-level viremia. After overcoming technical challenges, real-time adherence monitoring is feasible for resource-limited settings and may detect suboptimal adherence prior to viral rebound.
Real-time adherence monitoring; Wireless technology; Antiretroviral therapy
Current adherence assessments typically detect missed doses long after they occur. Real-time, wireless monitoring strategies for antiretroviral therapy may provide novel opportunities to proactively prevent virologic rebound and treatment failure. Wisepill, a wireless pill container that transmits a cellular signal when opened, was pilot tested in ten Ugandan individuals for six months. Adherence levels measured by Wisepill, unannounced pill counts, and self-report were compared with each other, prior standard electronic monitoring, and HIV RNA. Wisepill data was initially limited by battery life and signal transmission interruptions. Following device improvements, continuous data was achieved with median (interquartile range) adherence levels of 93% (87–97%) by Wisepill, 100% (99–100%) by unannounced pill count, 100% (100–100%) by self-report, and 92% (79–98%) by prior standard electronic monitoring. Four individuals developed transient, low-level viremia. After overcoming technical challenges, real-time adherence monitoring is feasible for resource-limited settings and may detect suboptimal adherence prior to viral rebound.
real-time adherence monitoring; wireless technology; antiretroviral therapy