The authors have declared that no competing interests exist.
Folic acid is essential in the body for the production of DNA and also plays various vital functions within the body. This study on folic acid was done to analyze the results of the Trivedi Effect® on its physicochemical and thermal properties with the help of analytical techniques. The method involves dividing the test sample into two parts. The first part was termed as a control sample, and no treatment was given to it; while the second part received the Biofield Energy Treatment remotely by a renowned Biofield Energy Healer, Gopal Nayak and termed as the treated sample. The study revealed that the particle sizes reduced by 7.01% (d10), 6.53% (d50), 8.37% (d90), and 15.99% {D(4,3)}, thus increased the surface area by 1.72%, in the treated sample compared with the control sample. The PXRD data showed changes in the peak intensities and crystallite sizes ranging from -36.81% to 113.41% and -15.79% to 318%, respectively, thus increased in the average crystallite size by 22.55% of the treated sample compared with the control sample. The TGA analysis of the treated sample revealed a 3.94% increase in total weight loss that resulted in the remarkable reduction in the residual amount by 14.99%, in comparison to the untreated sample. The latent heat of fusion (ΔHfusion) and latent heat of decomposition (ΔHdegradation) were significantly altered by -10.33% and 10.46%, respectively in the treated sample compared to the untreated sample. The study denoted that the Biofield Energy Treatment is a novel approach that could be used to develop some polymorph of folic acid and that might improve its solubility, dissolution, and bioavailability in comparison to the control sample. Hence, the treated folic acid in the nutraceutical/pharmaceutical formulations might be useful concerning better drug performance and efficacy.
Folic acid (vitamin B9) is the name used for a conjugate of 4-aminobenzoic acid and l-glutamic acid
Folic acid is mainly used in the treatment and prevention of folate deficiency and the other associated complications, such as anaemia and malabsorption due to bowel inability
The physicochemical properties of the drug are important regarding its absorption, distribution, metabolism, and excretion (ADME) profile and thus, it is advised to improve the biological activities and efficacy of the drug by altering its physicochemical properties
Folic acid was purchased from Alfa Aesar, USA; whereas the remaining chemicals used in the experiments were of analytical grade purchased from India.
The folic acid sample used in the study was first divided into two parts. The first part of the samples was not given the Biofield Energy Treatment and considered as the control sample. Besides, the second part of the sample was received the Trivedi Effect®-Energy of Consciousness Healing Treatment under standard laboratory conditions for 3 minutes and known as the Biofield Energy Treated folic acid sample. This Biofield Energy Treatment was provided remotely through the healer’s unique energy transmission process by a famous Biofield Energy Healer, Gopal Nayak, India, to the test sample. Later on, the control sample was treated with a “sham” healer for comparison purpose. The “sham” healer did not have any knowledge about the Biofield Energy Treatment. Now, the control and Biofield Energy Treated sample were kept in sealed conditions and characterized using modern analytical techniques.
The particle size analysis of folic acid samples was carried out on Malvern Mastersizer 2000, from the UK with a detection range between 0.01 µm to 3000 µm using wet method
Where dControland dTreatedare the particle size (μm) of the control and the Biofield Energy Treated folic acid samples, respectively.
The % change in surface area (S) was calculated using following equation 2:
Where SControl and STreated are the surface area of the control and treated folic acid samples, respectively.
The PXRD analysis of control and the Biofield Energy Treated folic acid was performed with the help of Rigaku MiniFlex-II Desktop X-ray diffractometer (Japan)
G = kλ/βcosθ(3)
Where k is the equipment constant (0.94), G is the crystallite size in nm, λ is the radiation wavelength (0.154056 nm for Kα1 emission), β is the full-width at half maximum (FWHM), and θ is the Bragg angle
The % change in crystallite size (G) of folic acid was calculated using the following equation 4:
Where GControl and GTreated are the crystallite size of the control and treated samples, respectively.
TGA/DTG thermograms of the control and the Biofield Energy Treated folic acid were obtained with the help of TGA Q50TA instruments. A sample of 4-15 mg was loaded to the platinum crucible at a heating rate of 10ºC/min from 25°C to 1000°C with the recent literature
Where WControl and WTreated are the weight loss of the control and the Biofield Energy Treated folic acid, respectively.
The % change in maximum thermal degradation temperature (Tmax) (M) was calculated using the following equation 6:
Where MControl and MTreated are the Tmax values of the control and treated folic acid, respectively.
The DSC analysis of folic acid was performed with the help of DSC Q200, TA instruments. A sample of ~1-5 mg was loaded to the aluminium sample pan at a heating rate of 10ºC/min from 30°C to 350°C
Where TControl and TTreated are the melting point of the control and treated samples, respectively.
The % change in the latent heat of fusion (ΔH) was calculated using the following equation 8:
Where ΔHControland ΔHTreatedare the latent heat of fusion of the control and treated folic acid, respectively.
The values were represented as Mean ± SEM (standard error of mean) of the independent experiments. For two groups comparison student’s
The particle size analysis corresponding to d10, d50, d90, and D(4, 3) of the control and the Biofield Energy Treated sample was done and the results are mentioned in
|
|
|
|
|
|
Control | 1.71 | 4.75 | 17.81 | 8.69 | 1.74 |
Biofield Treated | 1.59 | 4.44 | 16.32 | 7.30 | 1.77 |
Percent change |
-7.01 | -6.53 | -8.37 | -15.99 | 1.72 |
d10, d50, and d90: particle diameter corresponding to 10%, 50%, and 90% of the cumulative distribution, D(4,3): the average mass-volume diameter, and SSA: the specific surface area. denotes the percentage change in the Particle size distribution of the Biofield Energy Treated sample with respect to the control sample.
The decrease in particle size resulted in the increase in specific surface area (SSA) of the treated sample as the SSA was observed as 1.74 m2/g in the control sample; while it was increased by 1.72% and observed as 1.77 m2/g in the treated sample. The particle size distribution is important regarding the efficacy and performance of drug within the body in terms of its solubility, dissolution, and bioavailability
The PXRD diffractograms of the control and treated folic acid samples are shown in
|
Bragg angle (°2 θ) | Intensity (cps) | Crystallite size (G, nm) | |||||
|
|
|
|
|
|
|
|
|
1 | 5.46 | 5.49 | 307 | 194 | -36.81 | 99 | 240 | 142.42 |
2 | 10.88 | 10.96 | 373 | 559 | 49.87 | 195 | 203 | 4.1 |
3 | 12.29 | 13.07 | 261 | 557 | 113.41 | 50 | 209 | 318 |
4 | 16.95 | 16.99 | 357 | 491 | 37.54 | 84 | 78.1 | -7.02 |
5 | 19.23 | 19.31 | 91 | 118 | 29.67 | 227 | 218 | -3.96 |
6 | 20.45 | 20.55 | 188 | 237 | 26.06 | 114 | 96 | -15.79 |
7 | 21.68 | 21.76 | 112 | 117 | 4.46 | 181 | 212 | 17.13 |
8 | 26.66 | 26.69 | 593 | 870 | 46.71 | 110 | 110 | 0 |
9 | 27.75 | 27.77 | 253 | 470 | 85.77 | 199 | 168 | -15.58 |
10 | 29.6 | 29.52 | 565 | 436 | -22.83 | 42 | 92 | 119.05 |
11 | 31.27 | 31.31 | 109 | 145 | 33.03 | 103 | 120 | 16.5 |
12 | 34.34 | 34.46 | 111 | 146 | 31.53 | 91 | 86 | -5.49 |
13 | Average crystallite size ± SEM | 124.58 ± 17.57 | 152.68 ± 17.65 | 22.55 |
denotes the percentage change in the crystallite size of the Biofield Energy Treated sample with respect to the control sample,
SEM: standard error of the mean.
The results revealed that the Bragg’s angles of the peaks present in the diffractogram of the treated sample were slightly altered compared to the control sample; however the major alteration was observed in the peak at 2θ equals to 12.29º in the control sample that was observed at 2θ equals to 13.07º (entry no. 2) in the treated sample’s diffractogram. Besides, the peak intensities of the treated folic acid sample were altered ranging from -36.81% to 113.41%; and the crystallite sizes were varied ranging from -15.79% to 318%, compared to the control sample. The major alteration was also observed in the average crystallite size as it was observed as 152.68 nm in the treated sample, which was significantly increased by 22.55% in comparison to the control sample (124.58 nm). The alterations in the crystalline structure, as well as crystal morphology of drugs have been reported previously by using the Biofield Energy Treatment. It is supposed that the Consciousness Energy Healing Treatment might form a new polymorph of the compound by changing the peak intensities and crystallite sizes
The analysis of the thermal stability of both the samples,
|
|
|
||||
|
|
|
|
|
|
|
Control | 79.19 | 20.81 | 107.71 | 247.93 | 433.78 | 709.61 |
Biofield Energy Treated | 82.31 | 17.69 | 109.04 | 249.63 | 446.32 | 699.77 |
% Change |
3.94 | -14.99 | 1.23 | 0.68 | 2.89 | -1.39 |
denotes the percentage change of the Biofield Energy Treated sample with respect to the control sample,
= the temperature at which maximum weight loss takes place in TG or peak temperature in DTG.
The DTG analysis of both the samples showed four peaks in their respective thermograms (
The DSC analysis was used in this study to determine the thermal behaviour of the samples such as melting, crystallization temperature,
There were two peaks in the DSC thermograms of the control and treated sample (
|
|
|
|
---|---|---|---|
Peak 1 | Control sample | 184.82 | 113.30 |
Biofield Treated sample | 189.29 | 101.60 | |
% Change |
2.42 | -10.33 | |
Peak 2 | Control sample | 234.86 | 54.85 |
Biofield Treated sample | 231.11 | 60.59 | |
% Change |
-1.60 | 10.46 |
: Latent heat of fusion/decomposition;
denotes the percentage change of the Biofield Energy Treated sample with respect to the control sample.
The DSC results denoted that the thermal properties of treated folic acid were altered after the Biofield Energy Treatment that might occur due to some changes in the crystallization structure
The study of Biofield Energy Treated folic acid revealed the significant effect of the Trived Effect®-Consciousness Energy Healing Treatment on its physicochemical and thermal properties. It indicated the significant changes in the particle size distribution of folic acid after the Biofield Energy Treatment. The treated sample showed reduced particle size at d10, d50, d90, and D(4,3) by 7.01%, 6.53%, 8.37%, and 15.99%, respectively compared to the control sample. The decrease in particle size of the Biofield Energy Treated sample causes an increase in the specific surface area by 1.72% compared to the control folic acid sample. The PXRD diffractograms indicated significant alterations in the peak intensities and crystallite sizes ranging from-36.81% to 113.41% and -15.79% to 318%, respectively, compared to the untreated sample. The average crystallite size of the treated folic acid sample was found to be increased by 22.55% after the Biofield Energy Treatment in comparison to the control sample. The TGA data showed the increase in total weight loss of the Biofield Energy Treated sample by 3.94% that resulted in significant reduction in residue weight by 14.99%, compared to the control sample. The treated sample showed that the melting temperature and ΔHfusion were altered by 2.42% and -10.33%, respectively; while the degradation temperature and ΔHdegradation were changed by -1.60% and 10.46%, respectively compared to the untreated folic acid sample. The overall data indicated that the Trivedi Effect®-Consciousness Energy Healing Treated folic acid formed a new polymorph that may improve the solubility, dissolution, absorption, and bioavailability along with thermal stability compared to the untreated sample. Thus, it could be presumed that the Biofield EnergyTreated folic acid would be more efficacious in the pharmaceutical/nutraceutical preparations regarding the prevention and treatment of several diseases such as Alzheimer’s disease, memory loss, eye disease, age-related macular degeneration, age-related hearing loss, aging, allergic diseases, sleep problems, osteoporosis, depression, restless leg syndrome, nerve pain, vitiligo, gum infections, muscle pain, Fragile-X syndrome,
The authors are grateful to Central Leather Research Institute, SIPRA Lab. Ltd., Trivedi Science, Trivedi Global, Inc., Trivedi Testimonials, and Trivedi Master Wellness for their assistance and support during this work.