Pyridoxine (Vitamin B₆) acts as the cofactors or prosthetic groups for different enzymatic reactions and plays an important role in the proteins, lipids, carbohydrates metabolism, etc. This research work was performed the solid-state characterization to understand the change in the physicochemical and thermal properties of the Consciousness Energy Healing Treated pyridoxine compared to the control sample. Pyridoxine sample was divided into control and treated parts. Control part did not receive the Biofield Energy Treatment, while treated part received the Biofield Energy Healing Treatment (the Trivedi Effect^®) remotely by a famous Biofield Energy Healer, Alice Branton. The powder XRD peak intensities significantly altered ranging from -35.90% to 128% and crystallite sizes also significantly altered ranging from -42.74% to 7.38% of the treated pyridoxine compared to the control sample. However, the average crystallite size was meaningfully decreased by 14.51% of the treated pyridoxine compared with the control sample. The particle size values in the treated pyridoxine were significantly altered by -12.27% (d₁₀), -0.37% (d₅₀), -73.67% (d₉₀) and 1.73% {D(4,3)}, but the specific surface area was significantly increased by 9% compared to the control sample. The ∆H_fusion was significantly increased by 16.2% in the treated sample compared to the control sample. The overall weight loss was significantly decreased by 6.67%; however, the residue amount was significantly increased by 11.87% in the treated sample compared with the control sample. Similarly, the maximum thermal degradation temperature of 1^st and 2^nd peaks of the treated sample was increased by 1.03% and 2.15%, respectively compared to the control sample. Thus, it was assumed that the Trivedi Effect^®-Consciousness Energy Healing Treatment might lead to generate a new polymorphic form of pyridoxine which would offer better solubility, dissolution and good bioavailability compared to the control sample. The Consciousness Energy Healing Treated pyridoxine would be very useful to design novel pharmaceutical formulations that might be more efficacious against vitamin B₆ deficiency, Alzheimer’s disease, ansemia, cardiovascular disease, diabetes, seizures, tuberculosis, cancer, anxiety, asthma, depression, dysmenorrhea, etc.

INTRODUCTION

Pyridoxine commonly known as vitamin B₆ is a water-soluble vitamin which acts as the cofactors or prosthetic groups for different enzymatic reactions. It plays numerous important roles in proteins, lipids and carbohydrates metabolism. Besides, it also has a significant role in the normal function of the nervous system, immune system, red blood cell, endocrine system and also maintains the normal blood glucose level [1,2]. Pyridoxine can be interconverted into two forms, i.e., pyridoxal and pyridoxamine. Pyridoxine, pyridoxamine and other phosphorylated forms are the major forms of vitamin B₆ in plant food, while pyridoxal and pyridoxal-5ꞌ-phosphate are obtained from animal foods. Pyridoxine hydrochloride (Pyridoxine HCl) is the hydrochloride salt of vitamin B₆ and converted into its active co-enzymatic form pyridoxal-5ꞌ-phosphate (PLP) [1-4]. Pyridoxine HCl is commonly used as vitamin supplement or as a component of multivitamin preparations for the prevention    and    treatment    of    pyridoxine    deficiency, pyridoxine-dependency seizures, sideroblastic anemia, Alzheimer’s disease, metabolic disorders, pulmonary tuberculosis, cardiovascular disease, hyperhomocysteinemia, cancer, anxiety, asthma, attention deficit hyperactivity disorder (ADHD), depression, dysmenorrhoea, diabetes, post-partum lactation suppression, McArdle’s disease, osteoporosis, etc. [1,4-7]. Pyridoxine is photosensitive and degrades slowly when exposed to light. It is soluble in water and alcohol; insoluble in ether and chloroform; sparingly soluble in acetone. On decomposition, it releases oxides of nitrogen and hydrogen chloride which are very toxic fumes [8].

Scientific communities throughout the world carrying out research work for the improvement of better physicochemical properties of the pharmaceutical and nutraceutical compounds, because the physicochemical properties play a crucial role in its dissolution, absorption and bioavailability profile in the physiological system [9]. In this development, the Trivedi Effect^® (Biofield Energy Healing Treatment) has played a significant role in altering the physicochemical properties of nutraceutical/pharmaceutical compounds [10-13]. The Trivedi Effect^® is a natural and scientifically proven phenomenon in which a person can acquire this energy from the “Universe” and transfer it anywhere on the planet via the possible mediation of neutrinos [14]. This energy field exists surrounding the body of every living organism called Biofield, which is an infinite and para-dimensional electromagnetic field. Biofield based Energy Therapies have a significant beneficial outcome against various diseases [15]. The National Institutes of Health and National Center for Complementary and Alternative Medicine recommend and incorporated the Energy therapy under Complementary and Alternative Medicine (CAM) category that has been recognized by the most of the USA people [16,17]. Similarly, the Trivedi Effect^® has a significant impact on the transformation of the object(s) and the outstanding results were published in numerous peer-reviewed scientific journals. The Biofield Energy Healing Treatment has the amazing capability to transform the properties of metals and ceramics [18,19], organic compounds [20,21], microorganisms [22,23], various living cells [24,25] and improve the overall productivity of crops [26,27]. Therefore, the current study evaluated the impact of the Trivedi Effect^®-Consciousness Energy Healing Treatment on the physicochemical properties of pyridoxine using modern analytical techniques.

MATERIALS AND METHODS

Chemicals and reagents

The test sample pyridoxine hydrochloride was purchased from Tokyo Chemical Industry Co. Ltd., Japan, but the other chemicals were procured in India.

Consciousness energy healing treatment strategies

Pyridoxine was the test sample for the whole experiment, which further divided into two equal parts. One part of pyridoxine was received the Trivedi Effect^®- Consciousness Energy Healing Treatment remotely (3 min) by the eminent Biofield Energy Healer, Alice Branton, USA known as the Biofield Energy Treated pyridoxine. However, the second part of pyridoxine was considered as a control sample was treated with a “sham” healer, where the “sham” healer did not have any awareness in the Biofield Energy Treatment. After the treatment, both the samples were stored in sealed conditions and characterized sophisticated analytical techniques.

Characterization

The X-ray diffraction (PXRD) analysis of pyridoxine powder sample was performed with the help of Rigaku MiniFlex-II Desktop X-ray diffractometer (Japan) [28,29]. The crystallites size was calculated with the help of the Scherrer’s formula (1):

G = kλ/βcosθ                         (1)

Where G=crystallite size (nm), λ=radiation wavelength, k=equipment constant, β=full-width at half maximum and θ=Bragg angle [30].

The particle size distribution (PSD) analysis was performed using Malvern Mastersizer 2000 (UK) using the wet method [31,32]. The differential scanning calorimetry (DSC) analysis of pyridoxine was performed with the help of DSC Q200, TA instruments. The thermal gravimetric analysis (TGA) thermograms of pyridoxine were obtained with the help of TGA Q50 TA instruments [31,32].

The % change in the above parameters the treated sample were calculated compared to the control sample using the following equation 2:

(2)

Similarly, the crystallite sizes of the treated pyridoxine sample were significantly altered ranging from -42.74% to 7.38% compared to the control sample. However, the overall crystallite size of the treated sample (338.08 nm) was significantly decreased by 14.51% compared with the control sample (395.46 nm).

The change in the crystallite properties of the Biofield Energy Treated pyridoxine were significantly altered compared to the control sample. The peak intensity of each diffraction face on the crystalline compound changes according to the crystal morphology [33] and changes in the diffraction type provide the proof of polymorphic transitions [34,35]. The Trivedi Effect^® probably produced the novel polymorphic form of pyridoxine through Biofield Energy via neutrino oscillations [13]. Different polymorphic forms of pharmaceuticals have noteworthy effects on drug performance, such as bioavailability, therapeutic efficacy and toxicity [36,37]. Thus, the Trivedi Effect^® Treated pyridoxine would be better in designing novel pharmaceutical formulations.

Particle size analysis (PSA)

The particle size analysis of both the control and Biofield Energy Treated pyridoxine were performed and the data are presented in tabular format (Table 2). The particle sizes in the Biofield Energy Treated pyridoxine were significantly decreased by 12.27% (d₁₀), 0.37% (d₅₀) and 73.67% (d₉₀) compared to the control sample. However, the particle size value in the Biofield Energy Treated pyridoxine was increased at D(4,3) by 1.73% compared to the untreated sample. The specific surface area of Biofield Energy Treated pyridoxine was significantly increased by 9% compared to the untreated sample. The Trivedi Effect^® might be acted as an external force for contravention the larger particles to smaller particles size sample and increased the surface area of the particles. The particle size, shape and surface area have their impact on the solubility, dissolution rate, absorption, bioavailability and even the therapeutic potency of a drug [37,38]. Thus, it is anticipated that the treated sample might improve the therapeutic performances of pyridoxine HCl formulations.

CONCLUSION

The Consciousness Energy Healing Treatment has shown the significant effects on the physicochemical properties of pyridoxine. The powder XRD peak intensities and crystallite sizes of the Biofield Energy Treated pyridoxine were significantly altered ranging from -35.90% to 128% and -42.74% to 7.38%, respectively compared to the control sample. The average crystallite size of the Biofield Energy Treated pyridoxine was significantly decreased by 14.51% compared to the control sample. The particle size values in the treated sample were significantly decreased by 12.27%, 0.37% and 73.67% at d₁₀, d₅₀ and d₉₀, respectively, whereas the particle size increased by 1.73% at D(4,3) compared to the control sample. Hence, the specific surface area of treated pyridoxine was significantly increased by 9% compared to the control sample. The ∆H_fusion was significantly increased by 16.2% in the treated sample compared with the control sample. The total weight loss was significantly decreased by 6.67%; hence the residue amount was significantly increased by 11.87% in the treated pyridoxine compared with the control sample. The T_max of 1^st and 2^nd peaks of the treated sample was increased by 1.03% and 2.15%, respectively compared to the control sample. Thus, it was assumed that the Trivedi Effect^®-Consciousness Energy Healing Treatment might lead to generate a new polymorphic form of pyridoxine which would offer better solubility, dissolution and good bioavailability compared to the control sample. The Trivedi Effect^®-Consciousness Energy Healing Treated pyridoxine would be very useful to design better pharmaceutical formulations that might offer better therapeutic response against pyridoxine deficiency, pyridoxine-dependency seizures, sideroblastic anemia, Alzheimer’s disease, metabolic disorders, pulmonary tuberculosis, cardiovascular disease, hyperhomocysteinemia, cancer, anxiety, asthma, ADHD, depression, dysmenorrhoea, diabetes, post-partum lactation suppression, McArdle’s disease, osteoporosis, etc.

ACKNOWLEDGEMENT

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.

1.       Dakshinamurti S, Dakshinamurti K (2007) Vitamin B6 in Handbook of Vitamins. 4^th Edn. Zempleni J, Rucker RB, McCormick DB, Suttie JW, CRC Press, Taylor & Francis Group, Boca Raton, USA, pp: 315-360.

2.       https://en.wikipedia.org/wiki/Pyridoxine

3.       Aboul-Enein HY, Loutfy MA (1984) Pyridoxine Hydrochloride in Analytical Profiles of Drug Substances. Florey K (Ed.), Vol 13, Academic Press, Inc., Orlando, USA, pp: 448-478.

4.       Leklem JE (2001) Vitamin B6 in Handbook of Vitamins. 3^rd Edn. Rucker RB, Suttie JW, McCormick DB, Machlin LJ, Marcel Dekker, Inc., New York, pp: 339-396.

5.       http://www.naturalmedicinejournal.com/journal/2011-09/many-uses-vitamin-b6

6.       Qian B, Shen S, Zhang J, Jing P (2017) Effects of vitamin B6 deficiency on the composition and functional potential of T cell populations. J Immunol Res 2017: 2197975.

7.       AlSaad D, Awaisu A, Elsalem S, Abdulrouf PV, Thomas B, et al. (2017) Is pyridoxine effective and safe for post-partum lactation inhibition? A systematic review. J Clin Pharm Ther 42: 373-382.

8.       https://pubchem.ncbi.nlm.nih.gov/compound/pyridoxine_hydrochloride#section=Stability

9.       Chereson R (2009) Bioavailability, bioequivalence and drug selection. In: Makoid CM, Vuchetich PJ, Banakar UV (Eds) Basic pharmacokinetics (1^st Edn) Pharmaceutical Press, London.

10.    Trivedi MK, Branton A, Trivedi D, Nayak G, Bairwa K, et al. (2015) Spectroscopic characterization of disulfiram and nicotinic acid after biofield treatment. J Anal Bioanal Tech 6: 265.

11.    Trivedi MK, Tallapragada RM, Branton A, Trivedi D, Nayak G, et al. (2015) Evaluation of biofield energy treatment on physical and thermal characteristics of selenium powder. J Food Nutr Sci 3: 223-228.

12.    Branton A, Jana S (2017) The influence of energy of consciousness healing treatment on low bioavailable resveratrol in male Sprague Dawley rats. International J Clin Dev Anat 3: 9-15.

13.    Branton A, Jana S (2017) Effect of The biofield energy healing treatment on the pharmacokinetics of 25-hydroxyvitamin D3 [25(OH)D3] in rats after a single oral dose of vitamin D3. Am J Pharmacol Phytother 2: 11-18.

14.    Trivedi MK, Mohan TRR (2016) Biofield energy signals, energy transmission and neutrinos. Am J Modern Phys 5: 172-176.

15.    Rubik B, Muehsam D, Hammerschlag R, Jain S (2015) Biofield science and healing: history, terminology and concepts. Glob Adv Health Med 4: 8-14.

16.    Barnes PM, Bloom B, Nahin RL (2008) Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report 12: 1-23.

17.    Koithan M (2009) Introducing complementary and alternative therapies. J Nurse Pract 5: 18-20.

18.    Trivedi MK, Tallapragada RM, Branton A, Trivedi D, Nayak G, et al. (2015) Evaluation of atomic, physical and thermal properties of bismuth oxide powder: An impact of biofield energy treatment. Am J Nano Res Appl 3: 94-98.

19.    Trivedi MK, Nayak G, Patil S, Tallapragada RM, Latiyal O (2015) Studies of the atomic and crystalline characteristics of ceramic oxide nano powders after bio field treatment. Ind Eng Manage 4: 161.

20.    Trivedi MK, Branton A, Trivedi D, Nayak G, Panda P, et al. (2016) Gas chromatography-mass spectrometric analysis of isotopic abundance of 13C, 2H and 18O in biofield energy treated p-tertiary butylphenol (PTBP). Am J Chem Eng 4: 78-86.

21.    Trivedi MK, Branton A, Trivedi D, Nayak G, Panda P, et al. (2016) Isotopic abundance ratio analysis of 1,2,3-trimethoxybenzene (TMB) after biofield energy treatment (the Trivedi Effect^®) using gas chromatography-mass spectrometry, Am J Appl Chem 4: 132-140.

22.    Trivedi MK, Branton A, Trivedi D, Gangwar M, Jana S (2015) Antimicrobial susceptibility, biochemical characterization and molecular typing of biofield treated Klebsiella pneumoniae. J Health Med Inform 6: 206.

23.    Trivedi MK, Branton A, Trivedi D, Nayak G, Gangwar M, et al. (2015) Antibiogram, biochemical reactions and genotypic pattern of biofield treated Pseudomonas aeruginosa. J Trop Dis 4: 181.

24.    Trivedi MK, Branton A, Trivedi D, Nayak G, Bairwa K, et al. (2015) Effect of biofield treatment on physical, thermal and spectral properties of SFRE 199-1 mammalian cell culture medium. Adv Biochem 3: 77-85.

25.    Trivedi MK, Branton A, Trivedi D, Nayak G, Bairwa K, et al. (2015) Physical, thermal and spectroscopic characterization of biofield energy treated Murashige and Skoog plant cell culture media. Cell Biol 3: 50-57.

26.    Trivedi MK, Branton A, Trivedi D, Nayak G, Gangwar M, et al. (2015) Evaluation of vegetative growth parameters in biofield treated bottle gourd (Lagenaria siceraria) and okra (Abelmoschus esculentus). Int J Nutr Food Sci 4: 688-694.

27.    Trivedi MK, Branton A, Trivedi D, Nayak G, Gangwar M, et al. (2015) Morphological and molecular analysis using RAPD in biofield treated sponge and bitter gourd. Am J Agric Forestry 3: 264-270.

28.    (1997) Desktop X-ray diffractometer “MiniFlex+”. Rigaku J 14: 29-36.

29.    Zhang T, Paluch K, Scalabrino G, Frankish N, Healy AM, et al. (2015) Molecular structure studies of (1S,2S)-2-benzyl-2,3-dihydro-2-(1Hinden-2-yl)-1H-inden-1-ol. J Mol Struct 1083: 286-299.

30.    Langford JI, Wilson AJC (1978) Scherrer after sixty years: A survey and some new results in the determination of crystallite size. J Appl Cryst 11: 102-113.

31.    Trivedi MK, Sethi KK, Panda P, Jana S (2017) A comprehensive physicochemical, thermal and spectroscopic characterization of zinc (II) chloride using X‑ray diffraction, particle size distribution, differential scanning calorimetry, thermogravimetric analysis/differential thermogravimetric analysis, ultraviolet-visible and Fourier transform‑infrared spectroscopy. Int J Pharm Investig 7: 33-40.

32.    Trivedi MK, Sethi KK, Panda P, Jana S (2017) Physicochemical, thermal and spectroscopic characterization of sodium selenate using XRD, PSD, DSC, TGA/DTG, UV-vis and FT-IR. Marmara Pharm J 21/2: 311-318.

33.    Raza K, Kumar P, Ratan S, Malik R, Arora S (2014) Polymorphism: The phenomenon affecting the performance of drugs. SOJ Pharm Pharm Sci 1: 10.

34.    Brittain HG (2009) Polymorphism in pharmaceutical solids in drugs and pharmaceutical sciences. Volume 192, 2^nd Edn, Informa Healthcare USA, Inc., New York.

35.    Censi R, Martino PD (2015) Polymorph impact on the bioavailability and stability of poorly soluble drugs. Molecules 20: 18759-18776.

36.    Blagden N, de Matas M, Gavan PT, York P (2007) Crystal engineering of active pharmaceutical ingredients to improve solubility and dissolution rates. Adv Drug Deliv Rev 59: 617-630.

37.    Chereson R (2009) Bioavailability, bioequivalence and drug selection. In: Makoid CM, Vuchetich PJ, Banakar UV (eds) Basic pharmacokinetics (1^st Edn) Pharmaceutical Press, London.

38.    Khadka P, Ro J, Kim H, Kim I, Kim JT, et al. (2014) Pharmaceutical particle technologies: An approach to improve drug solubility, dissolution and bioavailability. Asian J Pharm Sci 9: 304-316.

39.    Dandan Han, Xiaona Li, Haisheng Wang, Yan Wang, Shichao Du, et al. (2016) Determination and correlation of pyridoxine hydrochloride solubility in different binary mixtures at temperatures from (278.15 to 313.15) K. J Chem Thermodyn 94: 138-151

40.    Zhao Z, Xie M, Li Y, Chen A, Li G, et al. (2015) Formation of curcumin nanoparticles via solution-enhanced dispersion by supercritical CO₂. Int J Nanomedicine 10: 3171-3181.