Dermal Toxicity Studies Research Articles

Evaluation of acute and subacute dermal toxicity of antibacterial bioactive glass-infused surgical cotton gauze in Wistar rats

Mesoporous bioactive glass, with its versatile characteristics and morphology, holds significant potential as an ideal hemostatic material. However, limited data is available regarding its toxicity levels. Consequently, this research intends to assess the acute and repeated dose dermal toxicity of Mesoporous antibacterial bioactive glass microsphere impregnated nonwoven surgical cotton gauze (MABGmscg) dressing in albino Wistar rats, following the standards set by the Organization for Economic Cooperation and Development. In the acute dermal toxicity study, the impact of MABG (@2000mg/kg BW) mscg dressing was assessed following a single dermal application in both male and female Wistar rats (n = 10). Mortality, clinical signs, body weight fluctuations and gross observations were consistently monitored over a14 day period following the single dose. The results indicated that, MABG (@2000mg/kg BW) mscg dressing upon dermal exposure did not cause any adverse effect in acute dermal toxicity study in Wistar rats compared to control group. Given that 2000 mg/kg BW of MABG was deemed a nontoxic dose, a repeated dose dermal toxicity study of MABGmscg dressing was subsequently conducted at three dose levels (@200, 500, 1000 mg/kg BW) over 28 consecutive days in Wistar rats. During the study period, no unscheduled deaths occurred, and there were no clinical signs associated with treatment, body weight variations or abnormal gross findings at necropsy in any groups. The analysis concluded that, MABGmscg dressing is safe to be considered as a hemostatic dressing at the various tested dose levels in Wistar rats.

Dermal toxicity studies of 1,2-benzisothiazolin-3-one (CAS number: 2634-33-5) in Sprague-Dawley rats

Biocides are used as preservatives in various household products, and 1,2-benzisothiazolin-3-one (BIT) is one of the popular chemicals. Therefore, BIT is highly likely to be exposed to human skin, necessitating dermal toxicity evaluation. In this study, we aimed to investigate dermal toxicity, eyes and skin irritation, and skin sensitization of BIT. All studies were conducted according to the Organisation for Economic Co-operation and Development testing guidelines. In acute dermal toxicity using rats, no treatment-related responses were observed at the highest dose (2000 mg/kg). A 28-day repeated dermal toxicity study at 1, 4, and 12 mg/kg/day showed transient local skin irritation lesions, including erythema, exfoliation, and crust formation. Based on no systemic effects, the no observed adverse effect level (NOAEL) of BIT of the 28-day repeated dermal toxicity study was determined to be 12 mg/kg/day. Eye and skin irritation tests showed that BIT is a strong irritant and corrosive to the eyes and a mild irritant to the skin. However, BIT showed no skin sensitization reactions in a local lymph node assay. These dermal toxicity studies can provide valuable information for the risk assessment of BIT.

Exploring the Wound Healing Potential of Hispidin.

Hispidin, a polyphenol component mainly derived from the medicinal mushroom species Phellinus and Inonotus, shows promise for biomedical applications, yet its potential in wound healing remains largely unexplored. This research investigates the wound healing effects of hispidin through in vitro and in vivo experiments, while also evaluating its antimicrobial properties and safety profile. In vitro scratch assays were conducted to evaluate the impact of hispidin on the migration of NIH-3T3 cells. The wound healing potential of hispidin was assessed in rats using excision wounds, dead space wounds, and linear incisions, treated with various topical ointments including a simple ointment, 2.5% (w/w) and a 5% (w/w) hispidin ointment, and a 0.2% (w/w) nitrofurazone ointment, administered at 0.2 g daily for 14 days. Hispidin demonstrated antimicrobial properties and was particularly effective against Staphylococcus epidermidis. Hispidin enhanced NIH-3T3 cell viability, and promoted wound closure in scratch assays, correlating with increased levels of FGF21, TGF-β1, EGF, and VEGF. In excision wound models, the 5% (w/w) hispidin ointment improved wound contraction, epithelialization, tissue regeneration, fibroblast activity, and angiogenesis. In the granulation tissue from dead space wound models, hispidin reduced pro-inflammatory cytokines (TNF-α, IL-6, IL-1β) and lipid peroxidation, while increasing anti-inflammatory cytokines (IL-10) and antioxidant activities (SOD, GPx, CAT), along with connective tissue markers like hydroxyproline, hexosamine, and hexuronic acid. Hispidin also enhanced wound breaking strength in incision models. Acute dermal toxicity studies indicated no adverse effects at 2000 mg/kg. These findings highlight hispidin's potential in wound care, demonstrating its antimicrobial, regenerative, and safety properties.

STUDY OF KAJJALIKODAYA MALAHARA FOR EVALUATION OF WOUND HEALING ACTIVITY

Introduction: Kajjalikodaya malahara, mentioned in the Rasatarangini text, is indicated in different types of wounds like chronic wounds and fistula in ano, which did not respond to other treatment modalities. So, this formulation was selected for the present study. Material and methods: The Kajjalikodaya malahara prepared as per reference -anagni (without fire) and also modified version- agni siddha (with fire) method and subjected for antimicrobial, acute dermal toxicity studies and also screened for wound healing efficacy in excision and incision wound healing models. Results: The trial drug prepared by both methods was found safe in an antimicrobial study and did not reveal any acute dermal toxic conditions. In excision and incision wound healing model showed better therapeutic efficacy. Conclusion: Both formulations were efficient in the wound healing model’s study. Compared to a modified version of the agni siddha test drug, classically prepared anagni siddha was better in therapeutic efficacy.

ACUTE TOXICITY STUDIES OF METHACRYLIC ACID BASED COMPOSITE HYDROGEL OF SALVIA SPINOSA SEED MUCILAGE: A POTENTIAL NON-TOXIC CANDIDATE FOR DRUG DELIVERY

Safety evaluation of a newly designed polymeric drug delivery system (DDS), with/without the addition of active pharmaceutical ingredients (APIs), is now mandatory for their regulatory approval for human use. Hence, Salvia spinosa seed mucilage/hydrogel (SSH) was treated with methacrylic acid (MAA) to synthesize a composite hydrogel (SSH-co-MAA). Acute oral and acute dermal toxicity studies of the SSH-co-MAA for API delivery were ascertained following OECD guidelines 420 and 402, respectively. Moreover, an ocular toxicity study was also performed and analyzed through Draize scale. Animals of two species, rodent (rat) and non-rodent (rabbit), were divided into four groups. Group A of both rats and rabbits was assigned as control and remained untreated. Meanwhile, groups B, C, and D were labelled as treated groups and received a single dose of SSH-co-MAA, i.e., 0.05, 0.3 and 2 g/kg body weight of the animal. During 14 days after the treatment, animal monitoring was done for behavioral changes, food and water intake, adverse effects, and mortality. All animals remained alive, with no statistically significant abnormality. Hematological and biochemical parameters of control and treated animals were analyzed after the completion of 14 days and found in harmonization. The vital organs of rats were removed to determine absolute organ weights. Histopathology of the vital organs of rats revealed normal cellular architecture, without any lesions. SSH-co-MAA was also free from dermal and ocular toxicity. The overall results of acute oral and dermal toxicity studies prove that SSH-co-MAA is safe, especially after oral administration. Hence, SSH-co-MAA can be used as a non-toxic excipient for drug delivery systems.

Wound-healing effect of topical nanoemulsion-loaded cream and gel formulations of Hippophae rhamnoides L. (sea buckthorn) fruit oil and their acute dermal toxicity study on female SD rats.

The objective of this study was to evaluate the efficacy and safety of topical nanoemulsion (NE)-loaded cream and gel formulations of Hippophae rhamnoides L. (sea buckthorn [SBT]) fruit oil for wound healing. The NE-loaded cream and gel formulations of H. rhamnoides L. (SBT) fruit oil (IPHRFH) were prepared and evaluated for their wound-healing activity on female Sprague-Dawley (SD) rats. They were further divided into groups (seven) and the wound-healing activity was determined by measuring the area of the wound on the wounding day and on the 0th, 4th, 8th, and 10th days. The acute dermal toxicity of the formulations was assessed by observing the erythema, edema, and body weight (BW) of the rats. The topical NE cream and gel formulations of H. rhamnoides L. (SBT) fruit oil showed significant wound-healing activity in female SD rats. The cream formulation of IPHRFH showed 78.96%, the gel showed 72.59% wound contraction on the 8th day, whereas the positive control soframycin (1% w/w framycetin) had 62.29% wound contraction on the 8th day. The formulations also showed a good acute dermal toxicity profile with no changes significantly affecting BW and dermal alterations. The results of this study indicate that topical NE-loaded cream and gel formulation of H. rhamnoides L. (SBT) fruit oil are safe and effective for wound healing. The formulations showed no signs of acute dermal toxicity in female SD rats.

Acute Toxicity Study of Hexane Extract of <i>Sodhita Semecarpus anacardium</i> L. Drupe in Wistar Albino Rats and its Prediction Using <i>In-Silico</i> Tool

Semecarpus anacardium L. belongs to the family Anacardiaceae. Its drupe is widely used in Ayurvedic formulations after sodhana processing as it is listed under Schedule E1 of the Drugs and Cosmetics Act 1940. In this study, sodhita Semecarpus anacardium L. drupe was extracted with n-hexane and the yield was found to be 56%. The extract was subjected to GCMS (Gas Chromatography Mass Spectrometry) analysis and its characteristics were studied using an in silico tool. Acute oral and dermal toxicity studies were performed on the Wistar albino rats as per the OECD 425 and 402 guidelines respectively. The GCMS data revealed the presence of C13H18O3 (m/z: 222.1) with an abundance of 93.63%. The compound was predicted as potentially hazardous with a probable mutagenic category of ICH M7 class 3. An oxirane functional group of the compound was predicted to cause potent irritation properties to the eyes and skin with positive scores of 0.76 and 0.57 respectively. The LD50 was found to be more than the limit dose of 2000mg/kg body weight upon oral administration. Acute dermal exposure at a limited dose of 2000mg/kg body weight did not cause mortality. However, inflammatory responses started appearing within 48 hours of exposure. Histopathology revealed mild dermal oedema, mild fibrosis, dilated follicles hyperplasia etc. No changes were found in haematological parameters. Inflammation and dermal allergic reactions were completely self-healed by the end of 14 days. The results suggest that the oil portion of the sodhita drupe possesses the irritant properties of the Semecarpus anacardium. It might be due to the presence of the compound C13H18O3 with Oxirane as a functional group.

Safety profile assessment of standardized root extract of Potentilla fulgens in Wistar rats: Acute and sub-acute dermal toxicity study

Potentilla fulgens Wall (Rosaceae), a well-known medicinal plant native to Asian regions has a rich history of traditional use for treating skin, gastrointestinal tract, and various metabolic disorders. Research has addressed that the plant is applied topically to treat conditions such as wounds, ulcers, and other skin ailments. Surprisingly, no prior investigation has explored the dermal toxicity of this plant. Therefore, the study was set to conduct the acute and sub-acute toxicity assessments on the ethyl acetate (EAPF) and methanol (MEPF) extracts of P. fulgenson Wistar rats. In the acute dermal toxicity study, rats received a single dose and were monitored for 14 days, while in the sub-acute study; they received a daily dose for 28 days. 2,000 and 5,000 mg/kg were tested by applying them to the shaved dorsal skin. Throughout the experiments, changes in physical appearance, behavior, and histological alterations were monitored. The results unequivocally revealed no abnormal physical or physiological changes, behavioral deviations, or mortality in any of the rats in both acute and sub-acute dermal toxicity assessments. Furthermore, there were no statistically significant differences (nsp > 0.05) in body weight, kidney, liver, spleen weights, hematological parameters, or blood biochemistry values between the treatment and control groups. These findings were further substantiated by the normal macroscopic and microscopic characteristics of the rats’ skin, kidneys, liver, and spleen. In conclusion, our study affirms that the application of EAPF and MEPF to the skin does not induce acute or sub-acute skin irritation nor elicit systemic toxic responses in rats.

Wound Healing and Acute Dermal Toxicity Studies of Ludwigia octovalvis (Jacq.) P. H. Raven (Onagraceae) in Sprague–Dawley Rats

Introduction. The aerial part of Ludwigia octovalvis has been used traditionally in some parts of Asia for the management of wounds owing to the presence of phytochemicals such as tannins, flavonoids, and triterpenoids among others. The incidence of wounds, their associated complications, and the cost of wound care are on the increase globally, therefore, the need to develop alternative wound care agents. The aim of this study was to scientifically investigate the wound healing potential of the ethanolic extract of L. octovalvis using the excision wound healing model in rats and also carry out an acute dermal toxicity investigation of the plant extract. Method. A 70% ethanol extract of L. octovalvis was prepared for the wound healing activity using the excision wound healing model in Sprague–Dawley rats. Aqueous creams (1, 3, and 10%) were prepared and topically applied to the wounds once daily according to the groups of animals. The wounds were assessed for rates of wound closure on days 3, 5, 7, 9, and 11. Re‐epithelialization periods were also determined. Sections of wound tissues obtained on day 13 were subjected to histological investigations. An acute dermal toxicity of the plant extract was investigated. Results. L. octovalvis treatment (1, 3, and 10%) exhibited a mean percentage wound contraction range of 85.36 ± 7.22–94.14 ± 2.23 on day 11. The extract exhibited re‐epithelialization periods of 17.3 ± 1.2, 19.8 ± 2.6, and 16.0 ± 1.7 days for the 1, 3, and 10% extract creams, respectively, whereas the cream‐only and 1% silver sulfadiazine treatments resulted in a re‐epithelialization period of greater than 28 days. Histopathological investigation revealed enhanced fibroblast infiltration and collagen deposition in the treatment groups. No adverse reaction was observed in the acute dermal toxicity study. Conclusions. Extract of L. octovalvis exhibited wound healing by enhancing wound contraction, re‐epithelialization, fibroblast infiltration, and collagen deposition at the wound site. The extract did not exhibit any toxic reaction in the acute dermal toxicity study.

Anti-psoriatic evaluation of aloe emodin-loaded topical hydrogel in an imiquimod-induced human plaque-type psoriasis in BALB/c mice

Aloe emodin, an anthraquinone derivative, mainly obtained from Aloe vera, possesses an extensive spectrum of pharmacological properties, including anti-proliferative, anticancer, wound healing, analgesic, anti-inflammatory, antibacterial, and antiviral properties. The objective of the present study was to prepare aloe emodin-loaded topical hydrogel formulations for managing plaque-type psoriasis. Different proportions of carbopol 940, chitosan, and hydroxyl propyl methyl cellulose K15M (HPMC K15M) were used as gelling agents. The prepared hydrogels were characterized for pH, viscosity, rheological behavior, spreadability, extrudability, swelling index, drug content, and accelerated stability. Based on physicochemical and in vitro permeation studies, PHGL1 containing aloe emodin (1%) and carbopol 940 (1%) was selected. The acute dermal toxicity study was also conducted as per the OECD guidelines 402. The mechanism of drug release followed Korsemeyer–Peppa’s model. The optimized batch showed a pH range from 6.867 ± 0.015 to 6.91 ± 0.254, drug content 94.6% ± 0.686% w/w of the active principle when studied in triplicate for drug content analysis, the measured viscosity of the formulation was 31402.33 ± 149.0783 mPaS exhibiting a shear thinning system along with thixotropic behavior at 25°C, and sustained drug release of 78% in 8 hours. An ex vivo permeation study demonstrated that 203.73 μg/ml/cm2 drug permeated through skin in 24 hours. Application of aloe emodin-loaded topical hydrogel to psoriatic skin resulted in a reduction of epidermal thickness, scaling, and ear thickness. The key inflammatory marker tissue necrosis factor (TNF-α) also showed a significant decrease. Compared with the marketed formulation, the test formulation showed no significant difference in the percentage reduction in ear thickness. No acute dermal toxicity was observed at the initial dose of 200 mg. The outcome suggests the promising potential of aloe emodin-loaded hydrogel in improving plaque-like psoriasis without dermal toxicity. Further studies are warranted to establish its efficacy in the management of psoriasis.

WOUND HEALING POTENTIAL OF ACACIA CATECHU IN EXCISION WOUND MODEL USING IN VITRO AND IN VIVO APPROACH

Objective: The objective of this work is to elucidate the wound healing capabilities of various extracts derived from the bark of Acacia catechu, and to explore their potential therapeutic effects. Furthermore, the examination of several seasons has been conducted to assess their influence on the examined parameters. Methods: In this study, albino mice were used to assess acute dermal toxicity, excision wound healing, and histological changes. The wounds were monitored, and the area of the wound was measured at the 0th, 4th, 8th, 12th, 16th, and 21st days as compared to the control animals. Results: The test extracts showed considerable protection and wound healing capabilities in acute dermal toxicity, excision wound, and histopathological studies. Among the tested extracts, the ethanolic extract showed the highest wound healing (46.68%, p<0.001), followed by the methanolic (38.50%, p<0.001), acetone (33.87%, p<0.05), aqueous (32.04%, p<0.001), chloroform (29.83%, p<0.05), and benzene extracts (28.60%, p<0.05) at the 21st d of wound healing. However, the samples gathered throughout the winter, summer, and rainy seasons did not show a statistically significant difference (p>0.05) in the present research work. Conclusion: This study helps to provide preliminary data on the concentration range of different extracts collected in different seasons. It is anticipated that this evaluation represents significant protective potential of indigenous flora for medicinal applications.

Acute Dermal Toxicity Study of Acacia concinna Pods Extract in Wistar Rats

Acute Dermal Toxicity Study of Acacia concinna Pods Extract in Wistar Rats

Promising Pharmacological Activities of Ziziphus Herbal Extract and its Formulations

The aim of the present research is to study the potential pharmacological activities of herbal extract of Ziziphus and its formulations. It is observed that the plant extracts of different species of Ziziphus have a variety of pharmacological activities. Due to antibiotic resistance, it is necessary to discover new sources of antibiotics. New technologies are used for the development of antimicrobial and antioxidant drugs with enhanced pharmacological activities. Also, scientists are concentrating on herbal medicines because of their numerous advantages over synthetic drugs. Now-a-days many of these herbal formulations, sold over the counter, are not properly standardized for quality and toxicity. In this research work the sub-chronic dermal toxicity study of Ziziphus oenoplia leaf extract containing Carbopol hydrogel formulation is evaluated on adult male Albino Wister rats. Here, the extract containing hydrogel in 3 doses, and 0.9% NaCl solution (negative control) has been applied on the shaved area of dorsolateral trunk of different groups of rats once a day for 28 days for the study. After conduction of the experiment, it has been observed that the control as well as the test groups of animals did not possess any mortality/ morbidity, clinical signs of toxicity or skin reactions such as edema or erythema. There has been no significant change in food consumption or any notable elevation in body weight in the animal groups throughout the experimental period. Thus, in this study the Ziziphus extract incorporated Carbopol hydrogel has been successfully evaluated for dermal toxicity which reveals that the formulation can be safely applied dermally for wound healing purpose.

Identification of Quercetin, Kaempferol and Luteolin from Methanolic Extract of <i>Corchorus depressus</i> and its Pre-Clinical Wound Healing

Corchorus depressus Linn. (Tiliaceae) has been extensively utilized in Odisha, India, and is considered sacred and religious in addition to being used in Pakistan, Baluchistan, and Sind for ethnopharmacological purposes. Ethno-pharmacological claims and lack of sufficient scientific data with respect to the wound-healing activity of the plant encouraged us to the preparation of herbal formulation and its evaluation against wound-healing models with the identification of the phytoconstituents present in the plant extract. The physiochemical properties of the plant like ash value, the preliminary phytochemical screening, the HPLC, HPTLC, FTIR analysis, and the dermal toxicity of the methanolic extract were carried out using standard methods. A stability study was conducted on the prepared ointment formulations. With the help of in vivo excision, incision, dead-space wound, mice-burn model, and along with in vitro stimulation of Interleukin-10 models, the wound healing potential was evaluated. The granulation tissue was collected for nitric oxide estimation and histopathological analysis. The tensile strength of the granuloma tissue and hydroxyproline content were estimated using standard methods. The methanolic extract ointment resulted in a steady contraction of wounds with time and caused significant inhibition in the level of nitric oxide in the scar tissue and aggregation of macrophages in histological examination. The incision model showed a significant (381.33±4.58, p<0.05) increase in the tensile strength of granuloma tissue when compared to the control (156.5±5.75). The dead space wound model demonstrated that the plant extract significantly increased (75.43±2.97, p<0.001) hydroxyproline content against the control. Methanolic extract ointment caused significant wound healing and reduced epithelialization time in the mice burn model from the 12th day till the 24th day as compared to the negative control. Observations of hematological and serum biochemical changes in the dermal toxicity study suggested that the herbal extracts are safe for use topically. In the accelerated stability study, there were no marks of physical instability in the prepared ointment. IR spectral analysis was successfully used to detect flavanones like Luteolin and flavonol such as Quercetin and Kaempferol in methanolic extract. The present findings provide scientific evidence that the plant Corchorus depressus Linn. (Tiliaceae) displayed wound healing activity, corroborating its traditional use by the Tribals of Odisha and the Indian system of medicine.

Anti-inflammatory, anti-proliferative and anti-psoriatic potential of apigenin in RAW 264.7 cells, HaCaT cells and psoriasis like dermatitis in BALB/c mice

AimsPsoriasis is an immune-mediated skin disease characterized by keratinocytes hyperproliferation, abnormal differentiation and inflammation. Therefore, this study aimed to investigate in-vitro and in-vivo anti-inflammatory and anti-proliferative activity to evaluate anti-psoriatic potential of apigenin. Main methodsFor in-vivo study, 5 % imiquimod cream was used to induce psoriasis-like skin inflammation in BALB/c mice to mimic human psoriatic conditions. PASI score, CosCam score, histopathology, immunohistochemistry, qRT-PCR, and ELISA were done to evaluate the anti-psoriatic potential of topically applied apigenin. For in-vitro studies, LPS-induced inflammation in RAW 264.7 was done, and qRT-PCR, ELISA, and immunofluorescence were conducted to evaluate the anti-inflammatory activity of apigenin. Migration and cell doubling assay in HaCaT cells were performed to assess the anti-proliferative effect of apigenin. Acute dermal toxicity profile of apigenin has also been done as per OECD guidelines. Key findingsResults showed that apigenin significantly reduce the PASI and CosCam scores, ameliorate the deteriorating histopathology, and effectively downregulated the expression of CCR6, IL-17A, and NF-κB. Apigenin effectively downregulated the expression and secretion of pro-inflammatory cytokines through IL-23/IL-17/IL-22 axis. Apigenin suppressed nuclear translocation of NF-κB in LPS-induced RAW 264.7 cells. Cell migration and cell doubling assay in HaCaT cells showing the anti-proliferative potential of apigenin and it was found safe in acute dermal toxicity study. SignificanceApigenin was found effective against psoriasis in both in-vitro and in-vivo models suggesting apigenin as a potential candidate for the development of anti-psoriatic agent.

Acute dermal toxicity study of flower essential oil from Etlingera fenzlii (Kurz.) K. Schum. in Wistar albino rats

WHO has emphasized the value of using green repellents to combat disease and supplement insecticide-based vector control strategies. These products are frequently labelled as safe which is a common misperception due to the presence of varying bioactive compounds that can either be toxic or non-toxic. Pertaining to this scenario, a scarcely studied plant Etlingera fenzlii is studied to analyse its toxicological effects on skin. The plant is endemic to Kamorta and Katchal islands of Nicobar group and Mount Harriet hill ranges of Southern Andaman. These plants are used by the Shompen tribes for their honey collection and also against stomach disorders, cough etc. It is crucial to comprehend the plant's safety levels and dose limitations considering its' proven fungicidal and mosquitocidal characteristics among their other functions. The current study evaluated the acute dermal toxicity of flower essential oil in Wistar rats in accordance with OECD recommendations. Topical application at a dose of 2000mg/kg body weight showed no signs of toxicity. Any changes in body weight, water intake, feed consumption or gross pathology were not observed in the tested animals which provide considerable evidence to support the safe topical application of the essential oil.

Topical application of aerial portion of Acalypha indica Linn ameliorates psoriasis in rodents: Evidences from in vivo and in silico studies

Ethanopharmacological relevanceAcalypha indica Linn. is a weed, used traditionally for different skin diseases such as eczema and dermatitis in various parts of India. There are no previous in vivo studies reported on the antipsoriatic potential of this medicinal plant. AimThe aim of this study was to investigate antipsoriatic activity of coconut oil dispersion of aerial portion of Acalypha indica Linn. Few lipid-soluble phytoconstituents of this plant were subjected to molecular docking studies on different targets to determine phytoconstituent responsible for antipsoriatic activity. MethodsVirgin coconut oil dispersion of aerial portion of the plant was prepared by mixing three parts of coconut oil and one part of powdered aerial portion. The acute dermal toxicity was determined according to OECD guidelines. Mouse tail model was used to evaluate the antipsoriatic activity. Molecular docking of phytoconstituents was carried out using Biovia Discovery Studio. ResultsIn acute dermal toxicity study,the coconut oil dispersion was found to be safe up to the dose of 20000 mg/kg. The dispersion exhibited significant antipsoriatic activity (p < 0.01) at the dose of 250 mg/kg; at 500 mg/kg dose, the activity was similar that of 250 mg/kg dose. In the docking study of the phytoconstituents, 2-methyl anthraquinone was found to be responsible for antipsoriatic activity. ConclusionThis study provides new evidence of Acalypha indica Linn as antipsoriatic plant and justifies its traditional use. Computational studies also endorse the results obtained via acute dermal toxicity study and mouse tail model for evaluation of antipsoriatic potential.

Dapsone-Loaded Mixed Micellar Gel for Treatment OF Acne Vulgaris

Mixed polymeric micelles are potential nanocarriers for topical drug delivery. Dapsone (DAP) is an antibacterial used as anti-acne agent, but challenged by low water solubility and poor skin permeability. In the present study, DAP-loaded mixed micellar gel was developed comprising Pluronics F-68 and F-127. Micelles were prepared by solvent evaporation method and particle size, ex vivo permeation, drug loading, and entrapment efficiency were determined. Central Composite Design was used to optimize formulation. Independent variables were concentration of Pluronics at three levels while micelle size and drug loading capacities were dependent variables. Droplet size ranged from 400 to 500 nm. Transmission electron microscopy revealed spherical morphology of micelles. Optimized micelles were incorporated into gel base using HPMC K100M, Sodium CMC, and Carbopol 980 as gelling agents. Gels were evaluated for pH, drug content, spreadability, rheology, syneresis, ex vivo permeation, and subacute dermal toxicity. Compared with solubility of free DAP (0.24+0.056 µg/ml), solubility in mixed micelles was 18.42±3.4 µg/ml in water at room temperature. Order of spreadability of gels was Na CMC < HPMC < Carbopol 980. Carbopol gels displayed thixotropy with index of 3.17. Syneresis for all gels from day 0 to day 30 was found to be in range of 4.2 to 15.6% w/w. Subacute dermal toxicity studies showed no signs of erythema and edema on rat skin until 21 days. These results suggest that mixed micelles can significantly increase solubility and permeability and sustain release of DAP and are suitable carriers for topical DAP delivery in anti-acne therapies.

Assessment of dermal toxicity of mustard oil based formulation of Nerium indicum Mill.

Nerium indicum Mill. with red flowers belong to family Apocynaceae is considered as botanical source of Rakta Karavira drug of Upavisha (semi-poisonous) category of Ayurvedic Pharmacopeia of India. Till date Rakta Karavira Taila (mustard oil based formulation of root bark of Rakta Karavira) has not been evaluated pharmacologically. In present study, acute and repeated dose 28 day dermal toxicity studies of Rakta Karavira Taila was carried out in Charles foster albino rats. Acute dermal toxicity study was assessed at a single dermal application of drug at limit dose of 2000 mg/kg body weight of rats and observed for fourteen consecutive days. The repeated dose 28-day dermal toxicity study was assessed on repeated dermal applications at limit dose of 1000 mg/kg body weight of rats for 28 days consecutive days as per OECD guideline. The test medication was applied equally over a region covering rats body surface area of about 10%. Effects on body weight, haematological, ponderal changes, biochemical, and histological studies were used to evaluate the toxicity of the Rakta Karavira Taila. No mortality and toxicity were observed on single dermal application at limit dose level of 2000 mg/kg in acute dermal toxicity study. On repeated dermal applications of Rakta Karavira Taila at limit dose of 1000 mg/kg, showed statistically significant decrease in weight of testes, increase in WBC and platelet count while rest of hematological and biochemical parameters are not affected in comparison to control group. Histopathological study showed inflammation and fatty degenerative changes in liver and kidney, degenerative changes in seminiferous tubules and decrease in spermatogenesis in drug administered group. Medicated oil prepared out of root bark of Nerium indicum with red flower with mustard oil has potential to produce adverse effect particularly on male reproductive system therefore, should not be used for longer duration at higher dose level.

Assessment of wound healing activity and safety profile of Amaranthus spinosus extract using incision wound healing model

The objective of the study was to determine efficacy of Amaranthus spinosus extract against inflammation and wound along with assessment of safety profile of drug upon topical application. The collected whole plant was extracted with ethanol (65 %). In vitro efficacy of extract was performed on HaCaT and MEF cells. Clonogenic and scratch assays were carried out to determine the wound healing activity of the extract. Acute oral and dermal toxicity studies were conducted in accordance with OECD recommendations in order to assess the drug's profile for safety. Biological efficacy of A. spinosus was determined using incision wound healing model and measuring the tensile strength of a healing skin. Results showed that A. spinosus extract significant reduced inflammation and wound area. The percentage viability of cells were 96.20 and 96.23 %, respectively for HaCaT and MEF cells after 48 h of treatment; however, surviving factor were 0.71 ad 0.79, respectively. The tensile strength was 574.5 g after treatment with drug as compared to the control group. It can be concluded based on findings that A. spinosus may be used as an alternative medicine in the healing of wound.