scholarly journals Formulation and Evaluation of New Dosage Form of Calcium and Vitamin D

2020 ◽  
Vol 8 (3) ◽  
pp. 235-237
Author(s):  
Satish Kumar Sharma ◽  
Anand Singh ◽  
Anil Bhandari ◽  
Sudhir Singh
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Dosage Form ◽  
Research Work ◽  
Temperature And Humidity ◽  
Chewable Tablets ◽  
Swallowing Reflex ◽  
Elder People

The aim of the research work was to develop a new dosage form (tablet in tablet) of calcium and vitamin D. In this research work vitamin D3 was used as vitamin D. This type of dosage form is very useful for elder people and children who have a week swallowing reflex. They have difficulty in swallowing tablets with water. In the present research work, pre-formulated and evaluated chewable tablets of calcium and vitamin D3 (from Formulation and Evaluation of Chewable Tablets of Calcium and Vitamin D) were taken and then moulded into a jelly like material under specified conditions of temperature and humidity and a new dosage form was developed which is sweet, flavored and chewable dosage form (tablet in tablet). The new dosage form was subjected to various tests for evaluation of the new dosage form.  

scholarly journals Development and Evaluation of Chewable Tablets of Calcium and Vitamin D

2020 ◽  
Vol 8 (3) ◽  
pp. 232-234
Author(s):  
Satish Kumar Sharma ◽  
Anand Singh ◽  
Anil Bhandari ◽  
Sudhir Singh ◽  
Sumer Singh
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Research Work ◽  
Cost Effective ◽  
Wet Granulation ◽  
Weight Variation ◽  
Chewable Tablets ◽  
Tablet Properties ◽  
Effective Product ◽  
Pharmacopoeial Specifications

The aim of research work was to prepare a formulation of calcium and vitamin D chewable tablets by wet granulation method using excipients and to evaluate the tablet properties. In this research work vitamin D3 was used as vitamin D. The blend was compressed on a rotary compresson machine. Tablets were subjected to various tests (weight variation, thickness, hardness and assay of calcium and vitamin D3 etc) and the results were in compliance with the pharmacopoeial specifications. All physical properties studied indicate that all excipients are good pharmaceutical excipients for tablets. The aim of this work was to minimise the complexity of formulation and to make cost effective product. Since tablets to be prepared are chewable so sweetening and flavouring agents  are to be incorporated to make the tablet palatable and easily acceptable.  

scholarly journals Development and Characterization of an Orodispersible Film for Vitamin D3 Supplementation

Molecules ◽  
2020 ◽  
Vol 25 (24) ◽  
pp. 5851
Author(s):  
Irma Elisa Cupone ◽  
Eleonora Dellera ◽  
Fabio Marra ◽  
Andrea Maria Giori
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Dosage Form ◽  
Daily Intake ◽  
Stability Study ◽  
Food Supplements ◽  
Oral Dosage ◽  
Residual Water ◽  
Tract Infections

Vitamin D plays a crucial and very well-known role in regulation of calcium homeostasis and bone metabolism and mineralization. However, a huge and more recent body of evidence supports the positive influence of vitamin D on the regulation of immune response, ranging from protection against respiratory tract infections to prevention and management of asthma. Nevertheless, vitamin D deficiency is a very common condition and there is an increasing need for suitable products for proper supplementation, allowing good compliance also in specific populations. Orally disintegrating tablets (ODT) were first developed to overcome the difficulty experienced by pediatric and geriatric patients of swallowing traditional oral dosage forms and, recently, orodispersible films (ODF) are gaining popularity as novel dosage form for assuming active pharmaceutical ingredients, vitamins, and ingredients for food supplements. This study describes a 2000 IU Vitamin D3 ODF for daily intake, consisting of hydrophilic polymers and suitable excipients, manufactured by film-casting process. Elongation-at-break (E%), Young’s modulus (Y), and tensile strength (TS) were investigated using a dynamometer. Chemical stability was evaluated assaying the vitamin D3 in the films stored at different environmental conditions. In addition, in vitro disintegration and dissolution studies were performed. Correlation existed between the mechanical properties of the film and the residual water, acting as plasticizer. The stability study showed that vitamin D3 assay was ≥90% also after 3 months at 40 °C. The film disintegrated in less than 1 min and the vitamin D3 released was ≥75% after 15 min. An ODF with suitable properties can be manufactured and used as innovative dosage form for vitamin D3 food supplements.

Vitamin D3 supplementation improves glycemic control in type 2 diabetic patients: Results from an Italian clinical trial

2020 ◽  
pp. 1-10
Author(s):  
Giuseppe Derosa ◽  
Angela D’Angelo ◽  
Chiara Martinotti ◽  
Maria Chiara Valentino ◽  
Sergio Di Matteo ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Metabolic Control ◽  
Vitamin D3 ◽  
Therapy Group ◽  
Hypoglycemic Agents ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Type 2 Diabetic

Abstract. Background: to evaluate the effects of Vitamin D3 on glyco-metabolic control in type 2 diabetic patients with Vitamin D deficiency. Methods: one hundred and seventeen patients were randomized to placebo and 122 patients to Vitamin D3. We evaluated anthropometric parameters, glyco-metabolic control, and parathormone (PTH) value at baseline, after 3, and 6 months. Results: a significant reduction of fasting, and post-prandial glucose was recorded in Vitamin D3 group after 6 months. A significant HbA1c decrease was observed in Vitamin D3 (from 7.6% or 60 mmol/mol to 7.1% or 54 mmol) at 6 months compared to baseline, and to placebo (p < 0.05 for both). At the end of the study period, we noticed a change in the amount in doses of oral or subcutaneous hypoglycemic agents and insulin, respectively. The use of metformin, acarbose, and pioglitazone was significantly lower (p = 0.037, p = 0.048, and p = 0.042, respectively) than at the beginning of the study in the Vitamin D3 therapy group. The units of Lispro, Aspart, and Glargine insulin were lower in the Vitamin D3 group at the end of the study (p = 0.031, p = 0.037, and p = 0.035, respectively) than in the placebo group. Conclusions: in type 2 diabetic patients with Vitamin D deficiency, the restoration of value in the Vitamin D standard has led not only to an improvement in the glyco-metabolic compensation, but also to a reduced posology of some oral hypoglycemic agents and some types of insulin used.

Vitamin-D-Effekte auf Komponenten des kardiovaskulären Risikos

2011 ◽  
Vol 20 (04) ◽  
pp. 314-319
Author(s):  
H. Sourij ◽  
H. Dobnig
Keyword(s):  
Vitamin D ◽  
Vitamin D3

ZusammenfassungGroße Beobachtungsstudien legen einen Zusammenhang zwischen Vitamin-D-Mangel und kardiovaskulärem Risiko bis hin zur Mortalität nahe. Manche Beobachtungen werden auch durch präklinische Studienergebnisse unterstützt. Für praktisch alle wichtigen kardiovaskulären Endpunkte fehlen heute jedoch Ergebnisse randomisierter und ausreichend langer durchgeführter Studien. Der Vitamin-D-Mangel ist ebenso wie andere Risikofaktoren für Herzkreislauf-Erkrankung äußerst prävalent, so dass auch kleinere Effekte theoretisch große Bedeutung für die Volksgesundheit haben könnten. Die DVO-Leitlinien empfehlen eine Vitamin-D-Gabe von 800–2000 IE Vitamin D3 täglich. Damit können nachteilige muskuloskelettale Effekte erwiesenermaßen vermieden und gleichzeitig auch mögliche kardiovaskuläre Vorteile erzielt werden.

Vitamin D3 and women's health

GYNECOLOGY ◽  
2019 ◽  
Vol 21 (1) ◽  
pp. 44-51
Author(s):  
Iuliia E Dobrokhotova ◽  
Ekaterina I Borovkova ◽  
Sofya A Zalesskaya ◽  
Victoria S Skalnaya ◽  
Ivan M Borovkov ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Negative Impact ◽  
Perinatal Outcomes ◽  
Hypovitaminosis D ◽  
Malignant Neoplasms ◽  
Cellular Functions ◽  
Prophylactic Drug ◽  
Drug Doses

Background. Vitamin D is an essential component that regulates calcium homeostasis and many other cellular functions. Hypovitaminosis D is associated with a risk of osteopenia, obesity, type 1 and type 2 diabetes, malignant neoplasms and immune disorders. Inadequate vitamin D intake during pregnancy increases a risk of pre-eclampsia, preterm birth, low birth weight as well as it has a negative impact on both children’s and adolescents’ health. It is important for the clinician to be known administrating of vitamin D prophylactic and therapeutic regimens according to serum 25(OH)D levels. Aim. To determine causes and effects of vitamin D deficiency and to elaborate ways of their correction. Materials and methods. To write this review a search for domestic and foreign publications in Russian and international search systems (PubMed, eLibrary, etc.) for the last 2-15 years was conducted. The review includes articles from peer-reviewed literature. Results. The article shows that vitamin D has a significant impact on both the cardiovascular, endocrine, digestive, respiratory and other systems functioning and perinatal outcomes that necessitates vitamin D deficiency correction. It provides schemes for effective therapeutic and prophylactic drug doses calculating depending on vitamin D3 blood serum concentration. Conclusion. Preference should be given to cholecalciferol (vitamin D3) due to its better absorption properties and more efficient conversion to active vitamin metabolites (class IIC).

The effect of supplementation of vitamin D in neurocritical care patients: RandomizEd Clinical TrIal oF hYpovitaminosis D (RECTIFY)

2020 ◽  
Vol 133 (4) ◽  
pp. 1103-1112 ◽  
Author(s):  
Michael Karsy ◽  
Jian Guan ◽  
Ilyas Eli ◽  
Andrea A. Brock ◽  
Sarah T. Menacho ◽  
...  
Keyword(s):  
Patient Outcome ◽  
Clinical Trial ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Neurocritical Care ◽  
Hypovitaminosis D ◽  
Mean Difference ◽  
Saps Ii ◽  
Gcs Score

OBJECTIVEHypovitaminosis D is prevalent in neurocritical care patients, but the potential to improve patient outcome by replenishing vitamin D has not been investigated. This single-center, double-blinded, placebo-controlled, randomized (1:1) clinical trial was designed to assess the effect on patient outcome of vitamin D supplementation in neurocritical care patients with hypovitaminosis D.METHODSFrom October 2016 until April 2018, emergently admitted neurocritical care patients with vitamin D deficiency (≤ 20 ng/ml) were randomized to receive vitamin D3 (cholecalciferol, 540,000 IU) (n = 134) or placebo (n = 133). Hospital length of stay (LOS) was the primary outcome; secondary outcomes included intensive care unit (ICU) LOS, repeat vitamin D levels, patient complications, and patient disposition. Exploratory analysis evaluated specific subgroups of patients by LOS, Glasgow Coma Scale (GCS) score, and Simplified Acute Physiology Score (SAPS II).RESULTSTwo-hundred seventy-four patients were randomized (intent-to-treat) and 267 were administered treatment within 48 hours of admission (as-treated; 61.2% of planned recruitment) and monitored. The mean age of as-treated patients was 54.0 ± 17.2 years (56.9% male, 77.2% white). After interim analysis suggested a low conditional power for outcome difference (predictive power 0.12), the trial was halted. For as-treated patients, no significant difference in hospital LOS (10.4 ± 14.5 days vs 9.1 ± 7.9 days, p = 0.4; mean difference 1.3, 95% CI −1.5 to 4.1) or ICU LOS (5.8 ± 7.5 days vs 5.4 ± 6.4 days, p = 0.4; mean difference 0.4, 95% CI −1.3 to 2.1) was seen between vitamin D3 and placebo groups, respectively. Vitamin D3 supplementation significantly improved repeat serum levels compared with placebo (20.8 ± 9.3 ng/ml vs 12.8 ± 4.8 ng/ml, p < 0.001) without adverse side effects. No subgroups were identified by exclusion of LOS outliers or segregation by GCS score, SAPS II, or severe vitamin D deficiency (≤ 10 ng/ml).CONCLUSIONSDespite studies showing that vitamin D can predict prognosis, supplementation in vitamin D–deficient neurocritical care patients did not result in appreciable improvement in outcomes and likely does not play a role in acute clinical recovery.Clinical trial registration no.: NCT02881957 (clinicaltrials.gov)

SUBLINGUAL VITAMIN D3 DRUG THERAPY IN VITAMIN D DEFICIENCY PATIENTS AT PRAVARA RURAL HOSPITAL

2019 ◽  
pp. 18-20
Author(s):  
Sanjeeva Kumar Goud T ◽  
Rahul Kunkulol
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Serum Vitamin ◽  
Cross Sectional ◽  
Serum Vitamin D ◽  
Significant Difference ◽  
Before And After

The present study was aimed to study the effect of Sublingual Vitamin D3 on Serum Vitamin D level in Vitamin D deficiency patients. This was a cross-sectional and interventional study. All the Vitamin D deficiency patients of age 18-60years and either gender, willing to participate in the study were included. Patients who had greater than 20 ng/ml were excluded from the study. The total number of participants in our study was 200, out of these 111 males and 89 females, the mean age in our study was 51.07 ± 7.39Yrs. All volunteers were given sublingual vitamin D3 (60,000IU) in six doses every fifteen days of follow up for 3 months. The subject’s serum 25(OH)D levels were estimated before and after the treatment of sublingual vitamin D3. There was a statistically significant difference in serum vitamin D3 level before 16.61±6.71 ng/ml and after 35.80±7.80 ng/ml after treatment with Sublingual Vitamin D3. Six doses of 60,000IU of Vitamin D3 sublingual route having improved the role of serum 25(OH)D levels in the treatment of Vitamin D3 deficiency patients.Keywords: Vitamin D3; Sublingual route

Adipose Tissue Remodeling by Prolonged Administration of High Dose of Vitamin D3 in Rats Treated to Prevent Sarcopenia

2017 ◽  
Vol 68 (9) ◽  
pp. 2139-2143 ◽  
Author(s):  
Alin Constantin Pinzariu ◽  
Sorin Aurelian Pasca ◽  
Allia Sindilar ◽  
Cristian Drochioi ◽  
Mihail Balan ◽  
...  
Keyword(s):  
Vitamin D ◽  
Adipose Tissue ◽  
Vitamin D3 ◽  
Term Treatment ◽  
High Dose ◽  
Omental Adipose Tissue ◽  
Long Term Treatment ◽  
Male Wistar Rats ◽  
Adipose Tissue Remodeling ◽  
Visceral Adipose

To examine the effect of high dose vitamin D3 treatment on visceral adipose tissue, we used vitamin D deficient male Wistar rats (18 months old) as a model of sarcopenia. The aging process is not only responsive for the losing muscle mass but also for redistribution of lipid resulting in altered fatty acid storage and dysdifferentiation of mesenchymal precursors. The effect of aging and vitamin D treatment (weekly oral gavage with 0.125 mg vitamin D3 (5000 IU)/100g body weight) on the omental adipose tissue were histological examinated. At the end of the experiment (9 monhs), adaptive changes to the reduction of adipogenesis and increased apoptosis in response to long-term treatment with vitamin D consisted of smaller size of adipocyte and moderate macrophage infiltrate.

Vitamin D analyses in veterinary feeds by gas chromatography-tandem mass spectrometry

2021 ◽  
pp. 146906672110002
Author(s):  
Andreas Lehner ◽  
Margaret Johnson ◽  
Alan Zimmerman ◽  
Justin Zyskowski ◽  
John Buchweitz
Keyword(s):  
Mass Spectrometry ◽  
Vitamin D ◽  
Gas Chromatography ◽  
Liquid Chromatography ◽  
Tandem Mass Spectrometry ◽  
Vitamin D3 ◽  
Mass Spectrometric ◽  
Chromatographic Behavior ◽  
Tandem Mass ◽  
Chromatography Tandem Mass Spectrometry

This report examines the feasibility of determination of Vitamin D3, D2 and their 25-hydroxy metabolites utilizing Gas Chromatography Tandem Mass Spectrometry (GC/MS/MS) as a potential alternative to popular Liquid Chromatography Tandem Mass Spectrometric (LC/MS/MS) methodologies. The GC/MS/MS approach was found to operate reasonably well despite long-standing concerns that gas-liquid chromatography of vitamin D compounds invoke thermal rearrangements owing to the relatively high inlet and capillary column temperatures used. The workup procedure involved incubation of feed samples with concentrated potassium hydroxide for overnight fat saponification, extraction of D Vitamins in n-hexane and reaction with N,O-bis(trimethylsilyl)trifluoroacetamide at 70 °C for 30 mins. In addition to parent compounds, small amounts of pyro-, isopyro-, and iso-vitamin D and isotachysterol3 variants were obtained from each Vitamin D-related compound upon extraction and GC/MS/MS analysis. Mass spectral and chromatographic behavior of these compounds are herein described and interpreted. Multiple Reaction Monitoring settings on GC/MS/MS included m/z 456→351 for Vitamin D3 and m/z 486→363 for Vitamin D2. Trimethylsilylation enabled single predominant peaks for Vitamins D3 and D2, and sample workup in the presence of deuterated Vitamin D analogs enabled accurate and precise sensitivity to 1 ppb (ng/g) in feeds. The method could be extended with reasonable accuracy to 25-hydroxy (25OH) compounds, but accuracies would be significantly improved by inclusion of respective 25OH-specific deuterated internal standards. The method was applied to 27 submissions of suspect dog foods of which 22% were discovered elevated and 44% were discovered to contain toxic levels of Vitamin D3. The described method was thus discovered to provide a suitable mass spectrometric approach for Vitamin D, proving itself here specifically of value in detection of ergocalciferol and cholecalciferol in animal feeds. The specificity and sensitivity of the tandem quadrupole approach can enable suitable applicability to serum determination if desired.

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