In vitro and Ex vivo study targeting the development of a Lavandula stoechas L. (Ustukhuddus) loaded Unani Transdermal patch: Implication of Unani Medicine in the treatment of Nisyan (Dementia).

Ustukhuddus (Lavandula stoechas L.) has been extensively used orally and topically in treating various neurological disorders, including dementia. The optimum potential of traditional dosage forms of Ustukhuddus is limited for various reasons. Transdermal drug delivery system (TDDS) is a novel means of drug delivery and is known to overcome the drawbacks associated with traditional dosage forms. The current study aimed at fabricating and evaluating Ustukhuddus hydro-alcoholic extract (UHAE) and essential oil (UEO) loaded matrix-type transdermal patches having a combination of hydrophilic - hydroxyl propyl methyl cellulose (HPMC) and hydrophobic - ethyl cellulose (EC) polymers. ATR-FTIR, DSC, XRD, and SEM analysis were carried out to study drug-polymer interactions, confirming the formation of developed patches and drug compatibility with excipients. We assessed the fabricated patches to evaluate their physicochemical properties, in vitro drug release, and permeation characteristics via ex vivo experiments. The physicochemical characteristics of patches showcased the development of good and stable films with clarity, smoothness, homogeneity, optimum flexibility and free from causing skin irritancy or sensitization. In vitro drug release and ex vivo permeation profile of developed patches were evaluated employing Franz diffusion cells. UHAE and UEO patches exhibited a cumulative drug release of 81.61 and 85.24 %, respectively, in a sustained-release manner and followed non-Fickian release mechanisms. The ex vivo permeation data revealed 66.82 % and 76.41 % of drug permeated from UHAE and UEO patches, respectively. The current research suggests that the formulated patches are more suitable for TDDS and hold potential significance in the treatment of dementia, contributing to enhanced patient compliance, thereby highlighting the implication of Unani Medicine in Nisyan (Dementia) treatment.

In vitro and In vivo study targeting the development of Unani Antidermatophytic Cream: Implication of Herbal Formulations in Treatment of Dermatophytosis.

Panwad (Cassia tora L.), Sarshaf (Brassica nigra L.) and Kunjad (Sesamum indicum L.) have been used in the treatment of ringworm infection since ancient times and are documented in classical literature of Unani Medicine. These plant drugs give promising results when used topically in the form of paste (zimad). Hence, the development and evaluation of a cream containing extracts of Tukhm-e-Panwad (Cassia tora L.), Sarshaf (Brassica nigra L.), and Kunjad (Sesamum indicum L.) was carried out to get better efficacy of the drugs. A total of 16 batches (F1-F16) of cream were prepared by adding varying concentrations of hydro-alcoholic extract of the drugs (20%, 40% and 50%) in water removable bases, and three batches were selected as final batches (F4-20%, F6-40% and F16-50%). In vitro antidermatophytic activity was conducted to optimize MIC against dermatophytosis-causing fungi. Dermal irritation of the prepared cream was determined in New Zealand Albino Rabbits. In vivo testing of the different concentrations of the prepared cream (20%, 40%, and 50%) was also carried out using Wistar rats to assess the antidermatophytic activity. Final batches showed good results in all the tested parameters and significant in vitro and in vivo antifungal activity in a dose-dependent manner. No microbial growth was seen in the prepared formulation. The study revealed significant antidermatophytic activity of the prepared cream against dermatophytosis-causing fungi. Hence, it can be concluded that the prepared cream can be an alternative topical agent with safe and effective antifungal activity for treating dermatophytosis.

A computational study on active constituents of Habb-ul-aas and Tabasheer as inhibitors of SARS-CoV-2 main protease.

A respiratory pandemic known as coronavirus disease-19 (COVID-19) has created havoc since it emerged from Wuhan, China. COVID-19 is caused by a newly emerged SARS coronavirus (SARS-CoV) with increased pathogenicity named severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Due to the lack of understanding of the mechanism of pathogenesis, an effective therapeutic option is unavailable. Epidemics described in Unani ancient literature include nazla-e-wabai and humma-e-wabai, and most of the symptoms of COVID-19 resemble nazla-e-wabai. Hence, in light of Unani literature, the treatment of COVID-19 can be managed with the composites prescribed in Unani medicine for nazla-e-wabai. In this study, a structure-based drug design approach was carried out to check the effectiveness of the pharmacologically active constituents of the Unani composites prescribed to treat nazla-e-wabai against SARS-CoV-2. We performed molecular docking of the active constituents of these composites against the main protease (Mpro), a potential drug target in SARS-CoV-2. Using detailed molecular docking analysis, Habb-ul-aas and Tabasheer were identified as potential inhibitors of SARS-CoV-2 Mpro. The active constituents of both these composites bind to the substrate-binding pocket of SARS-CoV-2 Mpro, forming interactions with key residues of the binding pocket. Molecular dynamics (MD) simulation suggested the binding of active constituents of Habb-ul-aas with SARS-CoV-2 Mpro with a strong affinity as compared to the constituents of Tabasheer. Thus, this study sheds light on the use of these Unani composites in COVID-19 therapeutics.Communicated by Ramaswamy H. Sarma.

Antilithiatic activity of a non-pharmacopoeial Unani formulation in chemically induced urolithiasis in rats.

OBJECTIVES: Parshioshan (Adiantum capillus-veneris L.), Duqu (Peucedanum grande C.B. Clarke), Kaknaj (Physalis alkekengi L.) and Kharekhasak (Tribulus terresteris L.) have been selected for this study as they have been associated with medicinal actions for litholytic activity. METHODS: The experiment was carried out in Sprague Dawley rats divided into seven groups, serving as plain control, disease control, standard control, curative A and B and preventive A and B groups. Animals of plain control received distilled water. Remaining six groups received Ethylene glycol 0.75% and Ammonium chloride 1% by adding in the drinking water for the first three days followed by 0.75% Ethylene glycol for 18 days. From 8th day till 21st day, standard control received Cystone in the dose of 750 mg/kg. Preventive and curative test groups were treated with hydroalcoholic extract of the test drug in the dose of 132 mg/kg and 264 mg/kg from 1st to 21st day and 8th to 21st day of calculi induction. RESULTS: Test drug reduced the number of calcium oxalate crystals in the urine; the level of urinary calcium, creatinine, magnesium, phosphorus, sodium and chloride decreased significantly in standard and test groups. The urine volume increased significantly in all the test groups. The level of serum calcium, urea, phosphorus and creatinine were significantly reduced in all the test groups. CONCLUSIONS: These results indicated that the test drug reduced and prevented the growth of urinary stones. Moreover, the test drug also possessed significant antiurolithiatic activity. However, the protective effect was found more than its curative effect.

Original Research Article (Experimental): Design and Development of Unani Emulgel for Vitiligo.

BACKGROUND: Vitiligo is not only a cosmetic problem, but also a social and psychological problem worldwide with the prevalence rate being highest in India. Treatment is unsatisfactory in Western System of Medicine. Unani System of Medicine (USM) possesses various drugs to treat vitiligo in both topical and oral dosage forms. Safoof-e-Bars (SB) is an important powdered dosage form used widely to treat vitiligo, internally as Zulal. Externally as Sufl (Sediment remained after decanting the soaked drug) is used. Babchi, a component of SB, is reported to contain psoralen, an important therapeutically active compounds for treating vitiligo. But as Psoralen - the active marker compound is very slightly soluble in water, so only negligible amount of it comes in zulal and most of the amount remains in sufl. That might be the reason for local application of sufl as recommended by Hakeems. But clinically it is observed that application of sufl is not followed by most of the patients, due to side effects associated with its application on skin. OBJECTIVE: The present study is designed to convert Safoof-e-Bars into a more convenient and appealing newly evolved dosage form 'emulgel' of same composition as of SB, so that it can be used by the patients easily without any side effects. MATERIALS & METHODS: Various batches of emulgel were prepared as preliminary batches and final batches using hydro-alcoholic extract of SB and different excipients in different concentrations. Preliminary batches were formed for selecting composition and concentration of extract and excipients for final batches. Total eight batches (F1F8) were prepared as final batches. Among these eight batches, batch F7 was selected as final batch, which was further evaluated on various parameters. Comparative quantitative analysis was done in Zulal, Hydro-alcoholic extract of SB and emulgel using HPLC. RESULTS: Optimized emulgel showed good result in physicochemical parameters. Highest percentage of psoralen was found in SB extract while lowest percentage was found in zulal. No growth of yeast and mould, and viable aerobic were found in emulgel on microbiological analysis. Emulgel was found to be stable for 3 months. CONCLUSION: Newly developed emulgel may be recommended with zulal instead of traditionally used sufl with zulal. In future emulgel will provide a solution for topical delivery of hydrophobic drugs and more convenient dosage form to apply locally.

Design and development of Unani anti-inflammatory cream.

Inflammation is the symptom of many diseases like rheumatoid arthritis and osteoarthritis. Many side effects are associated with the Non-Steroidal Anti-inflammatory Drugs (NSAIDs) used as conventional treatment for these conditions. In Unani, there are large number of single and compound drugs for inflammatory conditions. One dosage form of Unani system of medicine is named as Zimad in which paste is formed by mixing powder in oil, water, herbal extract. Zimadat is prepared just before application and used in many disease conditions as resolving, styptic, astringent, and antiseptic. As the pre-application procedure is difficult and also complicated for patients, hence, the present study attempted to modify the form of Zimad into cream. Various batches of cream of Zimad Mohallil were prepared by using extracts of the formulation and by adding additives. Various physicochemical parameters of prepared cream were carried and compared with market cream. The optimized cream of Zimad Mohallil (F4) was selected after preliminary tests and evaluated further. The optimized cream showed good results in physicochemical parameters equivalent to market sample. Zimad Mohallil was converted into convenient cream form by adding minimum additives and benefits could be achieved without any hassle and cumbersome work, which is encountered in crude or paste form. The optimized cream was equivalent to standard market cream.

Development of standard operating procedures of Habbe Shifa: A polyherbal Unani formulation.

BACKGROUND: Unani medicines are being used since antiquity. However, in spite of their efficacy, they have been widely criticized due to lack of standardization and poor quality presentation. For this reason, application of good manufacturing practices and development of standard operating procedures (SOPs) in the manufacture of herbal medicines became an essential tool to assure their quality. OBJECTIVES: Therefore, the objective of the study was to develop the SOP of Habbe Shifa (HS) regarding the particle size (PS), binder, temperature of drying, and duration of drying. MATERIALS AND METHODS: In this study, 24 batches of HS were prepared according to the instructions given in formulary to develop SOP. Three particle sizes (i.e., 80, 100, and 120 No. Mesh sieve), were taken for preparation of pills. Water and Samaghe Arabi (Gum Acacia mucilage [GAM]) were used as binder for preparing the lubdi (mass) in different batches. Different temperature and duration of drying were used to dry the pills in hot air oven to get satisfactory results. All the batches were assessed three times for hardness, friability, and disintegration time and mean regarded as standard parameter value. RESULTS AND CONCLUSION: The batch with 150 µm PS (100 mesh sieve), 5% w/w GAM used as a binder, dried at 90°C for 120 min showed hardness 3.50 ± 0.00 kg/cm, friability 0.02 ± 0.003%, and disintegration time 25.00 ± 0.57 min, which showed most appropriate result among all batches and considered as final batch. Its SOP may be used for future reference which can help in setting up regulatory limit to assure the quality of Unani medicines.

Standardization of the finished product: Habbe Irqun Nisa - A Unani anti-inflammatory formulation.

BACKGROUND: Habb (Pill) is one of the important dosage forms of Unani system of medicine. A number of effective formulations are manufactured in form of Habb because of its various advantages. Out of these, Habbe Irqun Nisa (HI) is a popular anti-inflammatory formulation used in the treatment of Warame Mafasil (arthritis) and Irqun Nisa (sciatica). Nowadays, with increased incidence of these diseases many non-steroidal anti-inflammatory drugs (NSAIDs) are being used in their treatment. Owing to the adverse effects of these drugs, the use of herbal medicines is seen as a better alternative. The basic requirement for the development of Unani system of Medicine is the standardization of single and compound drugs. HI is mentioned in National Formulary of Unani Medicne and selected for the present study. MATERIALS AND METHODS: HI was prepared manually with the powder of crude drugs, passed through sieve no. 100 and mixed with 1% w/w of gum acacia in mucilage form. It was then dried at 60°C for 90 min and then tested for its standardization on different physicochemical parameters, e.g. organoleptic properties, pH values, moisture content, ash values, friability, hardness, weight variation, disintegration time, and thin layer chromatography (TLC). RESULTS AND CONCLUSION: The data evolved from this study will make it a validated product and will help in the quality control of other finished products in future research.