In type 2 diabetes, insulin resistance is the main problem that is associated with a cluster of conditions such as obesity and hyperlipidemia. The present study was designed with the objective to evaluate the role of Mehamudgara vati (MMV), which was expected to work at the level of Medodhatwagni due to its Medohara properties, to have an effective control on type 2 diabetes. To fulfill the objective, known patients of type 2 diabetes attending the OPD and IPD of Kayachikitsa Department, IPGT and RA, were selected and were divided in two groups. In Group A, MMV was given 3 tab. thrice a day with lukewarm water for 3 months and in Group B, the patients who were already taking modern antidiabetic treatment, although their blood sugar level was not well under control, were additionally given MMV in the same manner. The formulation has shown a highly significant decrease in the fasting and post-prandial blood sugar level. The formulation has also shown a synergistic action when combined with the modern antidiabetic drugs due to its known hypolipidemic, hypocholesterolemic, hepatoprotective, antihyperglycemic, antistress, antioxidant and immunomodulatory activities.
Agni; antihyperglycemic; antihyperlipidemic; dosha; dushya; stress; type 2 diabetes
A study has been designed to evaluate the effectiveness of Dashanga Kwatha Ghana Vati in Urdhwaga Amlapitta (non-ulcer Dyspepsia). Randomized single blind, placebo controlled study was conducted in 138 patients attending O.P.D. of department of Basic Principles, I.P.G.T. and R.A., Gujarat Ayurved University, Jamnagar, and grouped into two. Both the groups consumed two tablets of either Dashanga Kwatha Ghana Vati or placebo, twice daily after food for a period of eight weeks. The patients were followed upto four weeks, 110 patients had completed the treatment and no adverse effects were reported during the treatment. Both groups had improved in the clinical symptoms and overall statistical significance was observed in the differences of scores between the two groups.
Dashanga Kwatha Ghana Vati; non-ulcer dyspepsia; Urdhwaga Amlapitta
The ayurvedic pharmacy needs to be established on the basis of modern quality standards. A study on ayurvedic Guti-Vati (tablets) was undertaken with this view, revealed that most of the tablets conform to the I P standards for hardness and DT. A few of the tablets showed curious responses similar to that of enteric coated and slow release tablets commonly used in modern medicine.
A systematic supporting study is essential so as to establish relationship of such responses to the nature of ingredients and their relevance with the indications and therapeutic utility described in Ayurvedic texts.
Lauha Bhasma is the most widely used bhasma preparation in therapeutics, but till date the temperature pattern to prepare Lauha Bhasma in electric muffle furnace is not fixed. So in this pilot study an attempt has been made to confirm the appropriate temperature pattern to prepare Lauha Bhasma. And emphasis has been given to evaluate this prepared Lauha Bhasma on classical analytical parameter, which reflects the physical and chemical properties of the Bhasma.
Iron is one among the major metals present in the earth's crust and is essential for sound sustenance of human body. Its deficiency leads to various health ailments. Contemporary medicine advises iron supplements in iron deficiency anemia. Ayurvedic classics also quote significant information about administration of iron. Lauha Kalpas are the unique compound herbo-mineral formulations where iron (Lauha) is used as a major ingredient. Relevant literature (Bhaishajya Ratnavali, Charaka Samhita, Rasendra Sara Samgraha etc.) reviewed to gather information about Lauha Kalpas. Critical analysis of these Lauha Kalpas reveals that ancient seers administered iron in a better acceptable form. Unlike popular understanding these are not only Khalviya preparations; but Churna (powders), Avaleha (confectionaries), Rasakriya (solidified decoctions), and Putapaka (incinerated) form of preparations are also found. Apart from solid dosage forms, semisolid dosage forms mentioned in classics are very much useful. Unfortunately most of the formulations are not found in the market. Hence Pharmaceutical firms may bring these unique dosage forms in to the market to supply the healthcare needs of the community. It is interesting that iron preparations are used in Ayurveda in different medical conditions apart from anemia (Pandu). This leaves a scope for further researches on different dosage forms of iron and their indications.
Ayurveda; Bhasma; Hematinics; Iron; Lauha Kalpa; pharmaceutics; Rasaushadhi
Mayūrapuccha Bhasma (Calx of peacock feather) is an Ayurvedic animal product prepared from peacock feathers by employing two different methods as mentioned in Siddhayogasaṅgraha and Bhaiṣajya saṁhitā. It is mainly indicated in vomiting, hiccough, and respiratory disorder.
Materials and Methods:
In the present study, Mayūrapuccha Bhasma was prepared by two classical procedures, one by burning on ghee flame and the other by giving Gajapuṭa (burning the peacock feathers at about 1000°C by using a thousand cow dung cakes). The products so obtained were subjected to various physico-chemical studies to find out ash value, pH value, specific gravity, moisture content, preliminary organic analysis, gravimetric analysis, chemical components, and to lay-down the pharmacopeial standards for standardization of Mayūrapuccha Bhasma.
Results and Conclusion:
Both the Bhasmas exhibited marked difference in color, moisture content, and percentage of inorganic compounds. The Bhasma prepared by Gajapuṭa method contains essential and beneficial inorganic elements, electrolytes in larger quantity, and lower moisture content.
Gajapuṭa method; ghee flame method; Mayūrapuccha Bhasma; physico - chemical analysis
Amaranthus spinosus Linn. (Amaranthaceae) is found throughout India. This tree species has been of interest to researchers because it is a medicinal plant employed in the Indian traditional system of medicine. Pharmacognostic standardization; physico-and phytochemical evaluation of the roots of Amaranthus spinosus was carried out, to determine its macro-and microscopical characters, and also some of its quantitative standards. Microscopical studies were done by using the trinocular microscope. Total ash, water-soluble ash, acid-insoluble ash, sulfated ash values, and alcohol-and water-soluble extractive values were determined for physico-chemical evaluations. A preliminary phytochemical screening was also done to detect different phytoconstituents. Microscopically, the root showed cork, cortex, stellar region, and calcium oxalate crystals. Powder microscopy showed anamalous secondary growth in between the xylem vessels and Calcium Oxalate crystals in the cortex region. Total ash was approximately three times more than acid insoluble and water soluble ash. The ethanol soluble extractive was approximately the same as the water soluble extractive. Thin Layer Chromatography (TLC) of the Petroleum-ether extract using Benzene : Ethyl acetate (6 : 1), showed six spots. In the chloroform extract, using Benzene : Ethyl acetate (4 : 1) nine spots were seen, and in the ethanol extract, using Chloroform: Methanol (93 : 7), only four spots were observed, using Iodine vapor as a viewing medium. Phytochemically, the root exhibited terpenes, alkaloids, glycosides, and sugars. These findings might be useful to supplement information with regard to its identification parameters, which are assumed significant in the way of acceptability of herbal drugs, in the present scenario, which lacks regulatory laws to control the quality of herbal drugs.
Amaranthus spinosus Linn.; pharmacognostic standardization; physicochemical evaluations
Pharmacognostical and preliminary phytochemical studies of Triphala churnam were carried out. The churnam of triphala consists of equal quantities of deseeded fruits of Terminalia chebula, Terminalia bellerica and Emblica officinalis. Triphala is exclusively used in more than 200 drug formulations in Indian system of Medicine. The present study involved the pharmacognostical evaluation of Triphala, in which morphological and powder microscopical characters were established. In addition, physico-chemical parameters such as ash values viz, total ash (10.21± 0.42), acid insoluble ash (2.54 ± 0.06), water-soluble ash (5.46±0.24) and sulphated ash (13.12 ± 0.63), extractive values viz, alcohol soluble extractive (11.20±0.18)) and water-soluble extractive (52.56±2.04), fluorescent analysis and microchmical tests were determined. The preliminary phytochemical study revealed the presence of carbohydrates, reducing sugar and tannins in aqueous extract and carbohydrates, flavonoids and tannins in alcoholic extract. This standardization would be very much helpful for the identification of Triphala churnam to differentiate from other powdered sources.
To establish the standardization parameters for complete pharmacognostic evaluation of stems of Thespesia lampas (T. lampas) (Cav.) Dalz & Gibs (Malvaceae), an important plant in the Indian system of medicine.
Morphological, microscopical, physico-chemical evaluations, florescence analysis of T. lampas stems were investigated and preliminary phytochemical analysis, GC-MS analysis and HPTLC fingerprinting were carried out for qualitative phytochemical evaluation of various extracts of stems of T. lampas.
Chemo-microscopy revealed the presence of lignin, starch grains and calcium oxalate crystals. Physico-chemical evaluation used to determine numerical standards showed a result with total ash (9.03 ± 0.05) % w/w, acid insoluble ash (1.50 ± 0.01) % w/w, water soluble ash (2.51 ± 0.02) % w/w, sulphated ash (7.50 ± 0.01) % w/w, ethanol soluble extractive (0.24 ± 0.02) % w/w, water soluble extractive (0.08 ± 0.01) % w/w, moisture content (6.03 ± 0.05) % w/w and total crude fibre content of stem powder (47.36 ± 0.32) % w/w. Behavior characteristics of the stem powder showed presence of steroids, starch, alkaloid, flavonoids and proteins. Preliminary phytochemical analysis revealed presence of glycosides, phenolic compounds, tannins, steroids, saponins, flavonoids, carbohydrates and proteins. GC-MS analysis showed the presence of fatty acids such as dodecanoic acid, tetradecanoic acid, n-hexadecanoic acid, 9-tetradecenal and HPTLC fingerprinting revealed the presence of β-sitosterol and quercetin in stems of T. lampas.
The pharmacognostic standardization of T. lampas is useful towards establishing standards for quality, purity and sample identification.
Thespesia lampas; Stems; Pharmacognosy; Malvaceae; Physicochemical analysis; Preliminary phytochemical testing; GC-MS analysis; Phelloderm; Periderm; Xylem
The metal, Tamra though mentioned in Ayurveda with a wide range of therapeutic utilities; is attributed with Ashta Maha Dosha. Hence, one should be cautious while using Tamra Bhasma. Considering the significance of Tamra in therapeutics, many studies have been carried out at different centers of India. Aim of the present study was to compile such available research works done on Tamra in the Department of Rasa Shastra and Bhaishajya Kalpana (RS and BK), IPGT and RA, Jamnagar and provide brief information about pharmaceutical, analytical, and pharmacological studies. Total eleven studies on Tamra Bhasma, which revalidated the impact of classical guidelines, safety issues, and therapeutic utilities, were screened from PG Department of RS and BK, Institute for Post-Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar. All studies revealed that Tamra Bhasma is safe clinically, experimentally at Therapeutic Equivalent Dose (TED) levels as no toxic hazards were reported during the treatment period. In all aspects (pharmaceutical, pharmacological, and clinical) Somnathi Tamra Bhasma has proven to be better than Tamra Bhasma. The clinical efficacy of Tamra Bhasma has been evaluated in Shvasa, Kasa, Yakrit Pliha Vriddhi, Grahani, etc. conditions. Satisfactory responses with a decrease in the intensity of signs and symptoms were reported in all the studies. Though certain limitations were observed in these researches, the results can be considered as a lead for further well stratified studies covering larger population. No adverse effects were reported in any of these studies.
Bhasma; Grahani; Rasa Shastra; safety; Somanathi Tamra; Tamra toxicity
Civanar amirtam is a siddha herbo- mineral formulation prescribed for rheumatism, bronchial asthma, tuber culosis and leprosy. Of the nine ingredients which constitute the preparation, four are inorganic and the others are plant drugs, Attempts have been made to chemically analyse and to identify the presence of each ingredient in the medicine to lay down standards. The identification of various chemical constituents present in the plant drugs using TLC technique by comparison with authentic chemicals, along with the physico-chemical parameters and quantification of inorganic ions established the presence of each ingredient. The parameters presented can be considered viable for prescribing dependable standards to this preparation.
Rhizomes of Alpinia calcarata Roscoe (Family: Zingiberaceae) possess several bioactivities and are used in the traditional medicinal systems of Sri Lanka.
The present investigation was carried out to standardize the rhizomes of A. calcarata by (a) screening for phytochemicals (b) determination of physico-chemical parameters and (c) development of a Densitogram.
Phytochemical screening revealed the presence of polyphenols, tannins, flavonoids, steroid glycosides and alkaloids in A. calcarata rhizomes. The percentages of moisture, total ash, acid insoluble ash, water soluble ash, ethanol extractable matter and water extractable matter were of 5.5 – 6.8, 8.3 – 8.8, 0.036 – 0.040, 7.2 – 7.8, 22.6 – 24.8 and 18.6 - 20.5 respectively.
The results obtained from this study can be used to standardize rhizomes of A. calcarata grown in Sri Lanka.
Alpinia calcarata; phytochemicals; physico-chemical parameters
Āmalaki (Embelica officinalis Gaertn.) is one of the most celebrated herbs in the Indian system of traditional medicine. It is one of the best Rasāyana-s (health promoting) drug. In Dugdhāmalakyādi yoga, Āmalaki (Embelica officinalis Gaertn.) powder is administered along with milk in case of svarabhaṅga (hoarseness of voice). Here an attempt is made to convert this formulation into chewable tablet without altering its property to improve its palatability, shelf life and fixation of proper therapeutic dose.
Chewable tablets were prepared by wet granulation method. Here, Āmalaki powder was prepared initially and it was mixed with additives and preservatives. Granules were prepared from this mixture by adding binding agent, finally compressed in to tablets.
Results and Conclusion:
The physico-chemical analysis of Āmalaki standard are: Foreign Matter-Nil, Acid insoluble Ash-0.51%w/w, Water soluble Ash-2.01% w/w, Alcoholic Extractives-44.48%, Aqueous Extractives 67.52%, pH-3.1, Moisture content-8.19%. Quality control test for chewable tablet was carried out and found satisfactory with general characteristics of tablet viz. hardness 1.8, disintegration time 15-20 min, friability 0.5%, weight variation +/- 3%. The TLC of Āmalaki powder showed 3 spots with Rf value 0.14, 0.4, and 0.73 and the chewable tablets showed 2 spots with Rf value 0.31 and 0.89 under 254 nm. The adaptation of modern techniques or methods to convert the Ayurvedic formulations without altering its therapeutic property is necessary to made them suitable for the present trends of newer drug delivery dosage forms.
Embelica officinalis Gaertn; chewable tablets; Dugdhāmalakyādi yoga
Samples of marketed Lauha bhasma from different manufactures were evaluated chemically. Apart from the 81 -85% iron content, the 15-19% other constituents were determined therein. Ferrous ferric and total iron in a single aliquot were determined spectrophotometrically, Qualitative and chromatographic analysis indicate the presence of sodium, potassium, calcium copper and cobalt in the samples, silicious matter and traces of ascorbic acid were present while tannin was absent in Lauha bhasma . Quantitatively sodium and potassium were determined by flame spectrometry. Upon fractionation, water soluble and acid soluble contents were determined.
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
Procedures for preparation of Lauha Bhasma are described in ancient texts of Ayurveda. These procedures also begin with different source material for iron such as Teekshna Lauha and Kanta Lauha etc. In the present study, we have selected different source materials viz. magnetite iron ore for Kanta Lauha and pure (Armco grade) iron turnings for Teekshna Lauha. The standard procedures of preparation of Lauha Bhasma are carried out in identical conditions for these two raw materials. The final product from the Puta are characterized by using X-ray diffraction and X-ray fluorescence spectroscopy to understanding the crystallographic form or forms of iron oxides and their composition at the end of each Puta. The iron content at the end of repeated Putas (18 for Kanta Lauha and 20 for Teekshna Lauha) have shown a decrease in case of Teekshna Lauha since the starting material is pure iron while it showed only marginal decreases in the case of Kanta Lauha because the Fe3O4 of magnetite is undergoing oxidation to Fe2O3. The trace elements remain within the Bhasma in the form of various oxides of Si, Al, Ca, etc.
Lauha Bhasma; X-ray diffraction; X-ray fluorescence
In the present research paper, the work done on pharmaceutical study of Lauha Bhasma conducted in the Department of Rasa Shastra under the postgraduate research programme is being presented. The pharmaceutical processing of Lauha Bhasma was performed by following samanya shodhana, vishesha shodhana and marana of Lauha. Under the process of marana, three specific pharmaceutical techniques were followed, viz. bhanupaka, sthalipaka and putapaka. During the putapaka process, an electric muffle furnace (EMF) was used. The temperature of puta was studied in two batches, viz. in Batch I, a temperature of 800°C was maintained whereas in Batch II, a temperature of 600°C was maintained. The purpose behind selecting two temperatures was to validate the process of marana of Lauha and to determine an ideal temperature for the preparation of Lauha Bhasma in EMF. It is found that after 20 puta at a temperature of 600°C, the Lauha Bhasma was prepared properly. The entire characteristic of Lauha Bhasma, like “pakwa jambu phala varna,” varitar, etc. was attained at 600°. At a temperature of 800°C, the process could not be carried out smoothly. The pellets turned very hard and brassy yellow in color. The desired color was attained only after decreasing the temperature in further puta.
Ayurveda; electric muffle furnace; Lauha; marana; puta; shodhana
Rudrakasha is the dried bead obtained from the ripe fruit of Elaeocarpus ganitrus Roxb. (Family: Elaeocarpaceae). Microscopic studies revealed the presence of a hard endocarp with lignified isodiametric sclereids, seeds with membranous seed coat, which enclosed a dense cellular endosperm comprising of calcium oxalate druses. Physicochemical parameters showed that total ash was 1.36 times and 1.56 times more than the acid insoluble ash and water-soluble ash, respectively. Further, ethanol had a maximum extractable value of 2.4% and moisture content was found to be 9.7%. Different extracts, petroleum ether, chloroform, ethanol and water were prepared. Chemically the extracts showed the presence of phytosterols, fats, alkaloids, flavonoids, carbohydrates, proteins and tannins. The extracts were evaluated for antifungal activity on different fungal strains. Chlorofom and ethanol extracts have high antifungal activity against Candida albicans. Whereas, chloroform, ethanol and water extracts showed moderate inhibition against Aspergillus niger.
Rudrakasha; Elaeocarpus ganitrus; antifungal activity; Candida albicans; Aspergillus niger
In the present work, fast disintegrating tablets of prochlorperazine maleate were designed with a view to enhance patient compliance by direct compression method. In this method, crospovidone (up to 3% w/w) and croscarmellose sodium (up to 5% w/w) in combination were used as superdisintegrants. Since disintegrants complement each other, accelerating the disintegration process when used together. Estimation of prochlorperazine maleate in the prepared tablet formulations was carried out by extracting the drug with methanol and measuring the absorbance at 254.5nm. The prepared formulations were further evaluated for hardness, friability, drug content uniformity, in vitro dispersion time, wetting time and water absorption ratio. Based on in vitro dispersion time (approximately 12 s), one promising formulation was tested for in vitro drug release pattern in phosphate buffer pH 6.8 and short-term stability (at 40°/70% RH for 3 mo), drug-excipient interaction (IR spectroscopy) were studied. Among the formulations tested, formulation DCPC4 containing 5% w/w of croscarmellose sodium and 3% w/w of crospovidone as superdisintegrant emerged as the overall best (t50% 7.0 min) based on drug release characteristics in pH 6.8 phosphate buffer compared to commercial conventional tablet formulation (t50% 17.4 min). Short-term stability studies on the promising formulation indicated that there were no significant changes in drug content and in vitro dispersion time (p<0.05).
Cros-carmellose sodium; crospovidone; fast disintegrating tablets; Prochlorperazine maleate
The present study was undertaken to find out the potential of gum from Moringa oleifera to act as a binder and release retardant in tablet formulations. The effect of calcium sulphate dihydrate (water insoluble) and lactose (water soluble) diluent on the release of propranolol hydrochloride was studied. The DSC thermograms of drug, gum and mixture of gum/drug indicated no chemical interaction. Tablets (F1, F2, F3, and F4) were prepared containing calcium sulphate dihydrate as diluent, propranolol hydrochloride as model drug using 10%, 8%, 6% and 4% w/v of gum solution as binder. Magnesium stearate was used as lubricant. Physical and technological properties of granules and tablets like flow rate, Carr index, Hausner ratio, angle of repose, hardness, friability and disintegration time were determined and found to be satisfactory. Tablets were prepared by wet granulation method containing calcium sulphate dihydrate as excipient, propranolol hydrochloride as model drug using 10%, 20% and 30% of gum as release retardant, magnesium stearate was used as lubricant. Similarly tablets were prepared replacing lactose with calcium sulphate dihydrate. Despite of the widely varying physico-chemical characteristics of the excipients, the drug release profiles were found to be similar. The drug release increased with increasing proportions of the excipient and decreased proportion of the gum irrespective of the solubility characteristics of the excipient. The values of release exponent ‘n’ are between 0.37 and 0.54. This implies that the release mechanism is Fickian. There is no evidence that the dissolution or erosion of the excipient has got any effect on the release of the drug. The t50% values for tablets containing calcium sulphate dihydrate were on an average 10%-15% longer than the tablets containing lactose as excipient. These relatively small differences in t50% values suggest that the nature of excipient used appeared to play a minor role in regulating the release, while the gum content was a major factor.
Binder; gum; Moringa oleifera; release retardant; tablet
Tarakeshwara Rasa (TR) is an Ayurvedic herbomineral compound formulation used in the intervention of Prameha vis-à-vis diabetes mellitus. The present study was executed to establish a fingerprint for this unique formulation, which can be adopted by the Ayurvedic pharmacies for drug standardization. TR is a formulation prepared by the trituration of four ingredients Abhraka Bhasma (AB), Loha Bhasma (LB), Vanga Bhasma (VB) and Rasa Sindhura (RS) in equal quantities with honey for one day. Each of the ingredients were prepared according to the norms of Ayurvedic classical texts and by employing Electric Muffle Furnace as heating device for incineration. To ensure the proper preparation of Bhasmas, standard tests (Bhasma Pariksha) were employed. After Bhasma complies these tests, TR was prepared and subjected for qualitative analysis, X-Ray Diffraction (XRD) and Scanning Electron Microscopy (SEM) studies. LB, AB, VB, RS and TR were also studied for free metal presence by employing phosphomolybdic acid. Chemical analysis of TR reveals that it contains Fe, Sn, Hg, Al, Mn, Ca and Mg. XRD study indicates that TR contains Fe2O3 (maghamite) in major phase and SnO2 (cassiterite), HgS, SiO2, HgO in minor phases. SEM study revealed that the compound is an agglomeration of particles. The particle size was in between 0.5 and 2 μ. Free metal detection by phosphomolybdic acid revealed the absence of free metals in the final Bhasmas. This is the first study establishing the characterization of Tarakeshwara Rasa.
Bhasma; characterization; rasaushadhi; scanning electron microscopy; X-ray diffraction
Lauha Bhasma, an ayurvedic drug, is widely used in iron deficiency anaemia, this ancient drug is claimed to be better absorbed gastrointestinally, and is also claimed to be devoid of the usual side effects associated with administration of the allopathic iron preparations, Physical and chemical methods of standardization required for any quality preparation, is not found in the ayurvedic and the modern literatures for Lauha Bhasma. Thus an approach has been made to standardize Lauha Bhasma. For the purpose of analysis, samples of all the three commonly available variants of Lauha Bhasma were considered. Qualitative analysis indicates the presence of iron both in the ferric and the ferrous forms, A simple spectrophotometric method has been used for simultaneous determination of ferric ferrous and the total iron content in a single aliquot.
In the present work, fast disintegrating tablets of prochlorperazine maleate were designed with a view to enhance patient compliance by effervescent method. In this method, mixtures of sodium bicarbonate and anhydrous citric acid in different ratios along with crospovidone (2-10% w/w), croscarmellose sodium (2-10% w/w) were used as superdisintegrants. Estimation of prochlorperazine maleate in the prepared tablet formulations was carried out by extracting the drug with methanol and measuring the absorbance at 254.5 nm. The prepared formulations were further evaluated for hardness, friability, drug content uniformity and in vitro dispersion time. Based on in vitro dispersion time (approximately 13-21 s), two promising formulations (one from each super-disintegrant) were tested for in vitro drug release pattern in pH 6.8 phosphate buffer, short-term stability (at 40°/75% relative humidity for 3 mo) and drug-excipient interaction (IR spectroscopy). Among the two promising formulations, the formulation containing 10% w/w of crospovidone and mixture of 20% w/w sodium bicarbonate and 15% w/w of citric acid emerged as the overall best formulation (t50% 6 min) based on drug release characteristics in pH 6.8 phosphate buffer compared to commercial conventional tablet formulation (t50% 17.4 min). Short-term stability studies on the promising formulations indicated that there are no significant changes in drug content and in vitro dispersion time (p<0.05).
Prochlorperazine maleate; fast disintegrating tablets; croscarmellose sodium; crospovidone
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
The microarray has contributed to developing the omic analysis. However, as it depends basically on the surface reaction, it is hard to perform bulk reactions and sequential multistep reactions. On the other hand, the popular microplate technology, which has a great merit of being able to perform parallel multistep reactions, has come to its limit in increasing the number of wells (currently, up to 9600) and reducing the volume to deal with due to the difficulty in operations.
Here, we report a novel microarray technology which enables us to explore advanced applications, termed microarray-with-manageable volumes (MMV). The technical essence is in the pipette-free direct parallel transfer from well to well performed by centrifugation, evading the evaporation and adsorption-losses during handling. By developing the MMV plate, accompanying devices and techniques, generation of multiple conditions (256 kinds) and performance of parallel multistep reactions, including PCR and in vitro translation reactions, have been made possible. These were demonstrated by applying the MMV technology to searching lysozyme-crystallizing conditions and selecting peptides aimed for Aβ-binding or cathepsin E-inhibition.
With the introduction of a novel concept microarray (MMV) technology, parallel and multistep reactions in sub-μL scale have become possible.