Hydrocortisone Acetate Research Articles

Sustained delivery of hydrocortisone acetate by CS/N-vinyl-2-pyrrolidone/CaCO3 microparticle hybrid hydrogels

The goal of this research is to develop a composite hydrogel system for sustained release of therapeutic agents. The hybrid hydrogels were prepared by radiation crosslinking on aqueous solution of Chitosan (CS)/N-vinyl-2-pyrrolidone (NVP) with different loads of CaCO3 in the presence of hydrocortisone acetate (HCA), an anti-inflammatory drugs. Physical characteristics of CS/NVP/CaCO3 were studied using X-ray diffraction (XRD) and infrared spectrophotometery (IR). The porous structure of resulted hydrogel was confirmed by SEM micrographs. The effect of doses and calcium carbonate amount on the swelling of the hydrogels was investigated. The ability of the prepared CS/NVP/CaCO3-based hybrid hydrogels to be used as drug carriers for anti-inflammatory-specific drug delivery system was estimated using HCA as a model drug. POLYM. COMPOS., 35:1176–1183, 2014. © 2013 Society of Plastics Engineers

Development and Optimization of a Capillary Zone Electrophoresis Technique for Simultaneous Determination of Miconazole Nitrate and Hydrocortisone Acetate in a Cream Pharmaceutical Formulation

A simple, fast, inexpensive, and reliable capillary zone electrophoresis (CZE) method for the determination of a mixture of miconazole nitrate (MCZ) and hydrocortisone acetate (HCZ) in a cream formulation has been developed and validated. Optimum conditions were sodium dihydrogen phosphate buffer (50 mM, pH 4) and 30 kV applied voltage in a 85 cm x 75 pm id capillary. Direct UV detection at 230 nm led to adequate sensitivity without interference from the sample excipients. MCZ and HCZ migrated in approximately 165 and 415 s, respectively. The analytical curves had a coefficient of correlation, r, of 0.9999 and 0.9996 for MCZ and HCZ, respectively. The LOD and LOQ were 0.28 and 0.93 microg/mL for MCZ and 0.38 and 1.27 microg/mL for HCZ, respectively. Thus, excellent accuracy and precision were obtained. Recoveries varied from 98 to 102%, and intraday and interday precision, calculated as the RSD, were less than 2.0% for each drug. The proposed CZE method displayed advantageous performance characteristics and can be considered suitable for QC of the MCZ and HCZ cream formulation.

Microstructure of microemulsion modified with ionic liquids in microemulsion electrokinetic chromatography and analysis of seven corticosteroids

In this work, the influences of ionic liquid (IL) as a modifier on microemulsion microstructure and separation performance in MEEKC were investigated. Experimental results showed that synergetic effect between IL 1-butyl-3-methylimidazolium tetrafluoro-borate (BmimBF4 ) and surfactant SDS gave a decreased CMC. With increment of IL in microemulsion, negative ζ potential of the microdroplets reduced gradually. The influence of IL on the dimensions of microdroplet was complicated. At BmimBF4 less than 8 mM, IL made microemulsion droplet smaller in size. While at BmimBF4 more than 10 mM, the size increased and reached to a maximum value at 12 mM, where the microdroplets were larger than that without IL. After that, the micreodroplet size decreased again. Relative fluorescence intensity of the first vibration band of pyrene to the third one (I1 /I3 ) enhanced as IL was added to microemulsion, which indicated that this addition increased environmental polarity in the inner core of microdroplets. Prednisone, hydrocortisone, prednisolone, hydrocortisone acetate, cortisone acetate, prednisolone acetate, and triamcinolone acetonide were analyzed with MEEKC modified with IL to evaluate the separation performance. Cortisone acetate and prednisolone acetate could not be separated at all in typical microemulsion. The seven analytes could be separated by the addition of 10 mM BmimBF4 into the microemulsion system. The method has been used for analysis of corticosteroids in cosmetic samples with simple extraction; the recoveries for seven analytes were between 86 and 114%. This method provides accuracy, reproducibility, pretreatment simplicity, and could be applied to the quality control of cosmetics.

SIMULTANEOUS DETERMINATION OF PRAMOCAINE HCL AND HYDROCORTISONE ACETATE IN PHARMACEUTICAL DOSAGE FORM

Two sensitive and selective methods were developed and validated for simultaneous determination of pramocaine HCl and hydrocortisone acetate in pharmaceutical dosage form. The first method is a spectrodensitometric method where pramocaine HCl and hydrocortisone acetate were separated using toluene:methanol:chloroform: 10% NH3 [(5:3:6:0.1, by volume) as the developing system followed by densitometric measurement at 290 nm] and 250 nm for pramocaine HCl and Hydrocortisone acetate, respectively. The second method is a high performance liquid chromatographic method for separation and determination of both drugs using reversed phase C18 column and mobile phase consisting of distilled water:acetonitrile:triethylamine (530:470:0.1, by volume); pH was adjusted to 3 by o-phosphoric acid. The proposed methods were successfully applied for the analysis of pramocaine HCl and hydrocortisone acetate in laboratory prepared mixtures and in pharmaceutical dosage form and the results obtained were assessed by applying the standard addition technique. Statistical comparison between the results obtained by applying the proposed methods and official method for the cited drugs was done and no significant difference was found at p = 0.05.

SAT0405 A Systematic Review of Comparative Efficacy of Various Corticosteroid Preparations for Intra-Articular and Soft Tissue Injections

BackgroundCorticosteroid (CS) injections are commonly used to treat musculoskeletal pain and inflammation. The comparative efficacy of various CS preparations used for such injections has not been systematically studied.ObjectivesTo compare the...

A rare association between Rathke’s cyst and hypophysitis in a patient with delayed sex development and growth failure

We report an 18-year-old Japanese male with a lack of secondary sex characterization and growth failure caused by a rare association between Rathke's cyst and hypophysitis. He was referred to us because of delayed secondary sex characterization. Endocrinological examination showed panhypopituitarism, and the replacement of hydrocortisone, levothyroxine, and desmopressin acetate (DDAVP) was initiated. Brain magnetic resonance imaging (MRI) showed a suprasellar region and a swollen pituitary stalk. The mass was partially resected using the transsphenoidal approach. The pathological diagnosis was hypophysitis and Rathke's cyst. Follow-up MRI performed 1 year after surgery showed that the size of sellar region had not changed. After surgery, in addition to pre-operative hormonal replacement, growth hormone and testosterone were initiated. Two years later, the size of sellar region remains unchanged. In conclusion, while an association between Rathke's cyst and hypophysitis is rare, we suggest that this condition should be included in differential diagnosis of the sellar region, even in adolescents.

Comparative determination of miconazole, nystatin, hydrocortisone and neomycin by HPTLC/HPLC-DAD

Two new validated methods for the quantification of miconazole (MIC), nystatin (NYS), hydrocortisone acetate (HCA) and neomycin (NS) by high performance thin layer chromatography (HPTLC)-densitometry and reverse-phase high-performance liquid chromatography procedure coupled with photodiode array detector (RP-HPLC-DAD) were developed and compared. HPTLC separations were performed using a mobile phase, ethylacetate:methanol:glacial acetic acid (60:40:0.4, v : v : v ) for MIC, NYS, HCA and ethylacetate for NS. For HPLC-DAD analysis, using an isocratic elution system, separation of all compounds was achieved. Good resolution and quantization were achieved, accuracy and precision, as well as detection and quantitation limits of the two methods, were evaluated and compared. Excellent linearity was observed for all of the standard calibration curves, and the correlation coefficients were above 0.9997. HPTLC limits of quantitation were 15.37×10 -2 , 9.8×10 -2 , 13.32×10 -2 and 15.19×10 -2 µg/mL for MIC, NYS, HCA and NS respectively, whereas HPLC limits were 6.80×10 -2 , 6.56×10 -2 , 1×10 -1 and 10.16×10 -2 µg/band for MIC, NYS, HCA and NS respectively. In comparison with HPLC, HPTLC is less expensive and faster procedure, requiring 2-3 h to analyse 10-12 samples on a single plate. The developed methods were proved to be specific, robust and accurate for the determination of cited drugs in pharmaceutical preparations.

In-capillary formation of polymer/surfactant complexes–assisted reversed-migration micellar electrokinetic chromatography for facile analysis of neutral steroids

In this study we developed a novel approach, using in-capillary formation of polymer/surfactant complexes (IPSC)–assisted reversed-migration MEKC (RM-MEKC), for the analysis of neutral steroids. This process involved two sequential events: in-capillary polymer/surfactant complexes formation during sample preconcentration, followed by IPSC separation. The procedure began with a polymer-filled capillary. Initially, on-line preconcentration of the sample was performed at the sample plug. Meanwhile, free surfactants migrated to interact with polymers, forming polymer–surfactant complexes. Analytes were then kinetically partitioned between the mixed phases (micelles and polymer–SDS complexes). Sodium dodecyl sulfate (SDS) and poly(N-isopropylacrylamide) (PNIPAAm) were employed as pseudo-stationary phases (PSPs). This system allowed the successful separation of five steroids (testosterone, hydrocortisone 21-acetate, dexamethasone, prednisolone, hydrocortisone) in acetate buffer and the determination of urinary free hydrocortisone; it also exhibited excellent performance for sample on-line concentration. The limit of detection for hydrocortisone was 20.98ng/mL (R2=0.9995). The polymer size, concentrations, end-group charges, and SDS concentrations were evaluated. This IPSC/RM-MEKC system, which can be adopted in commercial CE instruments, is easy to operate, suitable for combination with several sample preconcentration options, sensitive, robust, and environmentally sustainable. We suspect that such systems might have potential applications in clinical analyses and in microanalytical devices.

Simultaneous densitometric determination of hydrocortisone acetate and 2-phenoxyethanol in creams

A simple and rapid TLC-densitometric method has been developed for simultaneously determination of hydrocortisone acetate and 2-phenoxyethanol in cream. After extraction of the analyte with 96% ethanol, the extracts were spotted on precoated TLC silica gel 60 RP-18 F254s aluminum-backed sheets, which were then developed with a mixture of water-methanol (8:22, v/v). Quantitative evaluation was performed by measuring the absorbance reflectance of the analyte spots at 270 nm. The method was validated for specificity, linearity, accuracy, precision, and robustness. Good linearity was achieved in the concentration ranges of 4260–13,000 ng spot−1 (hydrocortisone acetate), and 750–4250 ng spot−1 (2-phenoxyethanol). The detection limit and quantification limit were 554 and 1660 ng spot−1 (hydrocortisone acetate), and 149 and 448 ng spot−1 (2-phenoxyethanol), respectively. No constant or proportional-systematic errors for both of the analytes were observed. RSD of repeatability and intermediate precision were foun...

Simultaneous determination of miconazole and hydrocortisone or mometasone using reversed phase liquid chromatography

Two simple, rapid and precise reversed phase liquid chromatographic methods have been developed and validated for the simultaneous determination of miconazole nitrate in two binary mixtures, with hydrocortisone acetate (Mixture 1) and mometasone furoate (Mixture 2). For the two mixtures, chromatographic separation was carried out on a C18 column. For mixture 1, a mobile phase consisting of 2.22 mM sodium dihydrogen phosphate (Triethylamine 0.2%):acetonitrile (45:55, v : v ) at a flow rate of 0.9 mL/min was used at ambient temperature. Quantitative determination of miconazole and hydrocortisone was achieved with UV detection at 215 and 245 nm, respectively. Linearity, accuracy and precision were found to be acceptable over the concentration range of 30-80 μg/mL for miconazole and 4-80 μg/mL for hydrocotisone. For mixture 2, a mobile phase consisting of acetonitrile:water (Triethylamine 0.2%) (70:30, v : v ) at a flow rate of 0.9 mL/min was used at ambient temperature. Quantitative determinations of miconazole and mometasone were achieved with UV detection at 215 and 250 nm, respectively. Linearity, accuracy and precision were found to be acceptable over the concentration range of 10-200 μg/mL for miconazole and 2-60 μg/mL for mometasone. The optimized methods were proved to be specific, robust and accurate for the quality control of the cited drugs in pharmaceutical preparations.

Simultaneous determination of chloramphenicol and hydrocortisone acetate in cream using TLC desitrometry method

A rapid and reproducible TLC method was developed for the determination of hydrocortisone acetate and chloramphenicol in cream. The analytes were dissolved with methanol and chromatographed on silica Gel GF 254 TLC plate using chloroform:ethyl acetate in the ratio of 1:1.5 (v/v) as mobile phase. Spots at Rf 0.29 and Rf 0.59 were recognized as chloramphenicol and hydrocortisone acetate, respectively. Quantitative analysis was done through densitometric measurement at wavelength 265 nm. Method was found linear over the concentration range of 300-900 ng/spot with the correlation coefficient of 0.999 and 0.998 for hydrocortisone acetate and chloramphenicol, respectively. Specificity showed calculation of purity and identity more than 0.99. The limit of detection (LOD) and the limit of quantification (LOQ) of the method were 23.84 and 71.51 ng/spot for hydrocortisone acetate, 21.06 and 63.18 ng/spot for chloramphenicol. The precision of this method was less than 2.8% whereas the means of the recovery data were 100.40± 0.579% for hydrocortisone acetate and 100.24±1.20% for chloramphenicol. The proposed method has been applied to the determination of hydrocortisone acetate and chloramphenicol in commercial cream formulations and the recovery of label claim were 99.23±0.66% (chloramphenicol) and 99.25±0.41% (hydrocortisone acetate) for brand A and 100.32±0.87% (chloramphenicol) and 100.53±0.78% (hydrocortisone acetate) for brand B. The developed method was successfully used for the assay of hydrocortisone acetate and chloramphenicol. The method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.DOI: http://dx.doi.org/10.3329/icpj.v2i1.12871 International Current Pharmaceutical Journal 2012, 2(1): 7-10

Therapy of adrenal insufficiency: an update

Adrenal insufficiency may be caused by the destruction or altered function of the adrenal gland with a primary deficit in cortisol secretion (primary adrenal insufficiency) or by hypothalamic-pituitary pathologies determining a deficit of ACTH (secondary adrenal insufficiency). The clinical picture is determined by the glucocorticoid deficit, which may in some conditions be accompanied by a deficit of mineralcorticoids and adrenal androgens. The substitutive treatment is aimed at reducing the signs and symptoms of the disease as well as at preventing the development of an addisonian crisis, a clinical emergency characterized by hypovolemic shock. The oral substitutive treatment should attempt at mimicking the normal circadian profile of cortisol secretion, by using the lower possible doses able to guarantee an adequate quality of life to patients. The currently available hydrocortisone or cortisone acetate preparations do not allow an accurate reproduction of the physiological secretion pattern of cortisol. A novel dual-release formulation of hydrocortisone, recently approved by EMEA, represents an advancement in the optimization of the clinical management of patients with adrenal insufficiency. Future clinical trials of immunomodulation or immunoprevention will test the possibility to delay (or prevent) the autoimmune destruction of the adrenal gland in autoimmune Addison's disease.

Injectable PLGA/hydrocortisone formulation produced by continuous supercritical emulsion extraction

The objective of the present study was to develop an anti-inflammatory prolonged action formulation for local injection in prefilled syringes. Hydrocortisone acetate (HA) was selected as a model corticosteroid drug to be incorporated in poly(lactic-co-glycolic) (PLGA) microspheres. The formulation was obtained by supercritical emulsion extraction in continuous operation layout (SEE-C) to test the process robustness for a continuous industrial production. PLGA/HA microspheres with mean sizes between 1 μm (SD±0.20) and 5 μm (SD±1.45) were obtained when operating at 80 bar and 38 °C with a L/G ratio of 0.1 in the counter-current tower. The produced microdevices showed excellent encapsulation efficiencies between 75% and 80%, depending on the emulsion formulations tested, and different sustained release in the range of 6-15 days. In dependence of the different emulsion (single or double) processed by SEE-C, different products can be obtained according to the therapeutic requests. SEE-C confirms to be an innovative and flexible technology for biopolymer microdevices production, coupling the efficiency of continuous operation to the easy process scalability.

Factors influencing the release kinetics of drug nanocrystal-loaded pellet formulations

Context: This article discusses the downstream processing of nanosuspensions into oral solid dosage forms.Objective: Various factors influencing the release kinetics of various pellet formulations containing drug nanocrystals have been evaluated. The effects of binder types, drug content and pellet type on the in-vitro dissolution profiles were investigated.Materials and methods: Hydrocortisone acetate (HCA) was nanosized by using a piston gap homogenizer Micron Lab 40. The nanosuspension was admixed to various binder solutions based on chitosan chloride, polyvinyl alcohol, hydroxypropyl methylcellulose or polyvinylpyrrolidone (PVP) and sprayed on sugar beads using fluidized bed coating. For comparison, matrix cores have also been prepared using the extrusion-spheronization process. An enteric top coating was applied onto both pellet types. All pellet formulations have been tested In in-vitro dissolution studies.Results and discussion: HCA nanosuspensions were compatible with all binders tested except for PVP. Various suspensions could be successfully transferred into spray coated pellets as well as matrix cores including a top coating. The different binder types have influenced the stability of the nanosuspensions, the zeta potential of the drug nanocrystals as well as the dissolution profiles of the final solid dosage forms.Conclusion: Nanosuspensions can be easily processed into various pellet formulations. Spray coating with water-soluble binders is recommended for high dose drugs. This technology is also more variable with respect to the drug load In the final dosage form. Matrix cores can be beneficial for highly water-insoluble formulations, especially when only relatively low doses are needed.

A β-cyclodextrin, polyethyleneimine and silk fibroin hydrogel containingCentella asiaticaextract and hydrocortisone acetate: releasing properties andin vivoefficacy for healing of pressure sores

Pressure sores are lesions caused by impaired blood flow. Conventional dressings can absorb exudates, but do not promote wound healing. A hydrogel composed of β-cyclodextrin (β-CD), polyethyleneimine (PEI) and silk fibroin (SF) was assessed for use in healing of pressure sores. The hydrogel was prepared by crosslinking β-CD-grafted PEI and SF using epichlorohydrin. The gel was then immersed in an aqueous solution of Centella asiatica extract (CAE) 0.7 mg/mL and/or hydrocortisone acetate (HCA) 0.5 mg/mL. The in vivo pressure sore-healing efficacy of the dry gel (with or without the drugs) was investigated in terms of the hyperplasia of epidermis and the number of neutrophils in the skin tissue. The specific loading of CAE was 0.0091 g/g of dry gel. The percentage of CAE released at 24 h at pH 3.0, 5.0 and 7.4 was approximately 63.9%, 55.0% and 44.4%, respectively. This pH-dependent release is possibly due to the degree of gel swelling, which decreased with increasing pH. The specific loading of HCA was 0.0050 g/g dry gel, and the percentage release of HCA at 24 h was around 20% at all three pH points. It is likely that HCA release is independent of pH. HCA is a hydrophobic compound, and therefore the release of HCA is affected by the partitioning of HCA between the β-CD cavity and the bulk water phase, but not by the degree of swelling of the hydrogel. The pressure sores treated with the hydrogel healed in 6 days, compared with 10 days for controls. In this study, a β-CD/PEI/SF hydrogel containing CAE and HCA reduced the healing time for pressure sores.

Diode Laser Treatment for Apthous Ulcers : A Case Report

Recurrent aphthous ulcerations (RAU) are common oral lesions that affect approximately 10% to 20% of the population. The disease is characterized by recurrent and painful ulcerations of the oral non-keratinized mucosa. Several therapies have been advocated to manage these lesions such as triamcinolone acetonide, hydrocortisone acetate, clobetasol propionate, chlorhexidine gluconate etc. Laser Treatment is a new treatment used to reduce the frequency of occurrence of mouth ulcers, pain and also to reduce the severity of the condition. The great advantage of this treatment is that majority of the patients undergoing this treatment did not suffer the recurrent episodes of the chronic mouth ulcers for at least a year. The present case report explains about usage of diode laser ain the management ofapthous ulcer.

A PAMPA Assay as Fast Predictive Model of Passive Human Skin Permeability of New Synthesized Corticosteroid C-21 Esters

The permeation properties of twenty newly synthesized α-alkoxyalkanoyl and α-aryloxyalkanoyl C-21 esters of standard corticosteroids: Fluocinolone acetonide, dexamethasone, triamcinolone acetonide and hydrocortisone were established using a PAMPA assay (70% silicone oil and 30% isopropyl myristate). The data were compared with parent corticosteroids with addition of mometasone furoate and hydrocortisone acetate. All newly synthesized corticosteroid C-21 esters have effective permeability coefficients higher then -6, mostly followed with high values of retention factors and low permeation. The examined compounds were grouped through relationship between obtained retention factors and permeation parameters (groups I–III). The classification confirmed group I (membrane retentions as well as permeation lower then 30%) for all corticosteroid standards except mometasone furoate, a potent topical corticosteroid which, with high membrane retention (81%) and low permeation (7.7%) fits into group III. The largest number of new synthesized corticosteroids C-21 esters, among them all fluocinolone acetonide C-21 esters, have high membrane retentions (32.4%–86.5%) and low permeations (1.3%–27.1%), fitting in group III. The classification was related to previously obtained anti-inflammatory activity data for the fluocinolone acetonide C-21 esters series. According to the PAMPA results the new synthesized esters could be considered as potential new prodrugs with useful benefit/risk ratio.

Disruption of the Phospholipase D Gene Attenuates the Virulence of Aspergillus fumigatus

Aspergillus fumigatus is the most prevalent airborne fungal pathogen that induces serious infections in immunocompromised patients. Phospholipases are key enzymes in pathogenic fungi that cleave host phospholipids, resulting in membrane destabilization and host cell penetration. However, knowledge of the impact of phospholipases on A. fumigatus virulence is rather limited. In this study, disruption of the pld gene encoding phospholipase D (PLD), an important member of the phospholipase protein family in A. fumigatus, was confirmed to significantly decrease both intracellular and extracellular PLD activity of A. fumigatus. The pld gene disruption did not alter conidial morphological characteristics, germination, growth, and biofilm formation but significantly suppressed the internalization of A. fumigatus into A549 epithelial cells without affecting conidial adhesion to epithelial cells. Importantly, the suppressed internalization was fully rescued in the presence of 100 μM phosphatidic acid, the PLD product. Indeed, complementation of pld restored the PLD activity and internalization capacity of A. fumigatus. Phagocytosis of A. fumigatus conidia by J774 macrophages was not affected by the absence of the pld gene. Pretreatment of conidia with 1-butanol and a specific PLD inhibitor decreased the internalization of A. fumigatus into A549 epithelial cells but had no effect on phagocytosis by J774 macrophages. Finally, loss of the pld gene attenuated the virulence of A. fumigatus in mice immunosuppressed with hydrocortisone acetate but not with cyclophosphamide. These data suggest that PLD of A. fumigatus regulates its internalization into lung epithelial cells and may represent an important virulence factor for A. fumigatus infection.

Placebo controlled, crossover validation study of oral ibuprofen and topical hydrocortisone-21-acetate for a model of ultraviolet B radiation (UVR)-induced pain and inflammation

BackgroundPain related to ultraviolet B radiation (UVR) induced sunburn is an established, simple, acute pain model. One of the major criticisms is related to the potential dermal adverse events caused by the UVR exposure. This study tried to validate the model for oral and topical drugs and to define the minimum required UVR exposure.MethodsThis subject- and observer-blinded, placebo-controlled, crossover study evaluated 600 mg oral ibuprofen (IB) and topical hydrocortisone-21-acetate (HC) twice daily (bid) in 24 healthy volunteers. Treatment started immediately after irradiation and again at 12 hours, 24 hours, and 36 hours post-UVR. Assessment of hyperalgesia to heat and signs of inflammation (erythema, skin temperature) for all areas was performed after UVR and again at 6, 12, 24, 36, and 48 hours. Subjects returned within 4–11 days to the study site for the second period of the study. As in the first period, subjects received HC at one side and topical placebo on the other side, but oral treatment was crossed-over.ResultsThe primary analysis failed to show the expected superiority of the IB-group vs the placebo group in period 1 of the study. Evaluating period 2 alone clearly showed the expected treatment effects of IB for erythema and heat pain threshold. The results were less pronounced for skin temperature. In contrast to IB vs oral placebo, there were no differences in treatment response between HC and topical placebo. UVR at all dosages induced profound erythema and reduction of heat pain threshold without causing blisters or other unexpected discomfort to the subjects. The changes were almost linear between 1 and 2 minimal erythema doses (MED), whereas the change from 2 to 3 MED was less pronounced.ConclusionUse of 2 MED in upcoming studies seems to be reasonable to limit subjects’ UVB exposure. The following procedural changes are suggested: Intensified training sessions before randomization to treatmentIncrease in sample size if they are crossover studiesSimplification in design (either oral or topical treatment)

Effects of Natural Beta-carotene and Commercially Available Combination of Beta-carotene, Vitamin E, Vitamin C and Minerals: A Prospective Comparative Study

Aim and objective: The purpose of this study was to determine effects of natural beta-carotene and revox in, reducing the oral symptoms of submucous fibrosis patients, thickness of collagen fibers in submucous fibrosis patients and to correlate the changes in epithelium and connective tissue. Materials and methods: The study population consisted of 50 patients with submucous fibrosis divided in two groups randomly. For patents in group A recived intralesional injection of 0.5 ml hyaluronidase 1500 IU and 05 ml hydrocortisone acetate 25 mg/ml were injected in buccal mucosa bilaterally in alternative week and natural beta-carotene capsule twice daily for 12 weeks along with ice cream stick mouth exercise. For group B patients intralesional injections and capsule revox were given twice daily for 12 weeks along with ice cream stick mouth exercise. Results: There is statistical significant improvement in mouth opening, reduction of burning sensation and decrease in thickness of collagen bundles were seen in all patients but there was early response in group A than group B Conclusion: Our preliminary findings suggest that both groups showed statistical significant results with early response in group A. The clinical comparison and effectiveness of natural beta-carotene and revox is not statistical significant.