Sodio fosfato bibasico diidrato
Sodium phosphate dibasic dihydrate – Na₂HPO₄·2H₂O
Sinonimi: fosfato disodico, disodio idrogenofosfato; E339(ii) (uso alimentare)
INCI / Funzioni: regolatore di pH (tampone), stabilizzante di fase acquosa, coadiuvante di processo in oral care

Definizione
Sale inorganico alcalino del sistema fosfato, in forma diidrata. Si presenta come solido cristallino bianco, inodore, altamente solubile in acqua. È impiegato per creare e mantenere pH stabili nell’intervallo neutro-leggermente alcalino, in coppia con sodio fosfato monobasico (NaH₂PO₄). È usato in cosmetica, oral care, alimentare e farmaceutica come componente di soluzioni tampone affidabili.
Calorie (valore energetico)
0 kcal per 100 g (composto inorganico, non apporta energia metabolizzabile).
Dati di identificazione e specifiche
Formula: Na₂HPO₄·2H₂O | Massa molare: 177,99 g/mol | CAS: 10028-24-7 | EC: 231-448-7
Aspetto: cristalli/polvere bianchi | Odore: assente
Solubilità in acqua (25 °C): elevata (ordine decine di g/L; rapidamente dissolvibile) | Insolubile in etanolo
pH tipico (sol. 1–2%): ~8,7–9,2
Densità apparente (polvere): ~1,5 g/cm³ | Igroscopicità: moderata
Stabilità: perde acqua di cristallizzazione per riscaldamento; evitare umidità/CO₂ (variazione pH)
pKa del sistema fosforico (a 25 °C, per riferimento di tampone): pKa₁ ≈ 2,15; pKa₂ ≈ 7,20; pKa₃ ≈ 12,35
→ Il sistema NaH₂PO₄/Na₂HPO₄ tampona al meglio intorno a pH 6,2–8,2.
Ruolo funzionale e chiarimento “sequestrante”
Il ruolo primario è tamponare: mantiene il pH stabile assorbendo aggiunte acide o basiche moderate.
Il legame con ioni Ca²⁺/Mg²⁺ è debole e, in condizioni alcaline e ad alta durezza, i fosfati possono precipitare sali di calcio (es. fosfato di calcio). Dunque non è un chelante “forte” (come citrati o EDTA) e non va usato per sequestrare la durezza: se serve controllo dei metalli, si affiancano citrato di sodio o EDTA a basso dosaggio.
Compatibilità formulativa
Tensioattivi: ottima con anionici, anfoteri e molti non-ionici; verificare con cationici ad alto dosaggio.
Polimeri e gelificanti: generalmente compatibile con carbomeri neutralizzati, gomme naturali, acrilati; controllare il pH target.
Pigmenti/minerali: stabilizza la fase acquosa; attenzione a sistemi ricchi di Ca²⁺ (rischio velature/precipitazioni).
Attivi sensibili al pH: consente di “bloccare” il pH in finestre ristrette (es. enzimi, fluoruri in oral care).
Linee guida d’uso (indicative)
Cosmetica leave-on / rinse-off: 0,05–0,50% per fine pH-trim e stabilità di routine.
Oral care (dentifrici/collutori): 0,2–2,0% in coppia con NaH₂PO₄ (pH target 6,0–7,5) e fluoruri.
Alimentare (E339(ii)): dosaggi secondo categoria d’uso e disciplinari specifici.
Preparazione del tampone: sciogliere i sali separatamente, unire sotto agitazione; regolare il pH con piccole aggiunte della specie acida (NaH₂PO₄) o basica (Na₂HPO₄). Misurare dopo equilibrio termico.
Esempi pratici di tamponi fosfato (acqua purificata, 25 °C, indicativi)
pH ≈ 6,5: ~80–85% NaH₂PO₄ + 15–20% Na₂HPO₄ (in massa di sali “anh.” equivalenti)
pH ≈ 7,0: ~60–65% NaH₂PO₄ + 35–40% Na₂HPO₄
pH ≈ 7,4: ~45–50% NaH₂PO₄ + 50–55% Na₂HPO₄
pH ≈ 8,0: ~25–30% NaH₂PO₄ + 70–75% Na₂HPO₄
(La forza ionica e la concentrazione influenzano leggermente l’esatto pH: verificare sempre a banco.)
Applicazioni tipiche
Detergenti delicati, shampoo, bagnodoccia: stabilità del pH e prestazioni costanti in acque dure.
Gel e lozioni: stabilità di viscosità e di attivi pH-sensibili.
Oral care: tampone con fluoruri e agenti antitartaro; comfort orale (pH fisiologico).
Make-up a base acquosa: controllo del pH per stabilità colore/pigmenti.
Alimentare: regolatore di acidità/stabilizzante; emulsionante nei formaggi fusi.
Qualità, gradi e specifiche
Disponibile in grado tecnico, alimentare (E339(ii)) e farmaceutico (monografie locali). Parametri comunemente richiesti: titolo/assay, metalli pesanti (Pb, As, Cd) a livelli molto bassi, perdite all’essiccamento (acqua cristallina), pH della soluzione, insolubili, carica microbica per gradi food/pharma.
Sicurezza, normativa e ambiente
Tossicità: bassa alle concentrazioni d’uso; può irritare occhi/pelle e vie respiratorie in polvere concentrata.
Allergenicità: non nota per reazioni allergiche da contatto.
Cosmetici UE (Reg. 1223/2009): non soggetto a restrizioni; uso conforme a Buone Pratiche di Fabbricazione.
IFRA: non applicabile (non è fragranza).
Alimentare: additivo E339(ii); limiti e condizioni d’impiego secondo normativa di categoria.
Ambientale: i fosfati possono contribuire a eutrofizzazione se rilasciati in quantità; gestire scarichi e uso in ottica responsabile.
Stoccaggio: contenitori ermetici, luogo asciutto e fresco; evitare assorbimento di umidità e CO₂; tenere lontano da acidi forti (reazioni di neutralizzazione).
Troubleshooting formulativo
Velo/precipitati bianchi in presenza di acque dure o sali di calcio: ridurre pH target, diminuire concentrazione di fosfato, aggiungere citrato/EDTA a basse dosi, o usare acqua deionizzata.
Deriva di pH dopo 24–48 h: verificare forza del tampone (totale molare), temperatura e anidride carbonica disciolta; ritarare con piccole aggiunte della coppia acido/base.
Interferenze con attivi: controllare compatibilità con enzimi, sali di alluminio (antitraspiranti) e cationici ad alto dosaggio; ottimizzare la sequenza di aggiunta.
Conclusione
Il sodio fosfato bibasico diidrato è un pilastro del controllo pH nelle formulazioni a base acquosa: versatile, economico, prevedibile. Usato correttamente in coppia tampone con NaH₂PO₄, garantisce stabilità chimico-fisica, performance costanti e buona compatibilità con la maggioranza degli eccipienti cosmetici e oral care. Non sostituisce un chelante: ove serva controllo dei metalli, si integra con citrato o EDTA. La gestione accurata di pH, durezza, concentrazione e condizioni di stoccaggio assicura prodotti stabili, sicuri e conformi.
Bibliografia__________________________________________________________________________
Buck CL, Wallman KE, Dawson B, Guelfi KJ. Sodium phosphate as an ergogenic aid. Sports Med. 2013 Jun;43(6):425-35. doi: 10.1007/s40279-013-0042-0.
Abstract. Legal nutritional ergogenic aids can offer athletes an additional avenue to enhance their performance beyond what they can achieve through training. Consequently, the investigation of new nutritional ergogenic aids is constantly being undertaken. One emerging nutritional supplement that has shown some positive benefits for sporting performance is sodium phosphate. For ergogenic purposes, sodium phosphate is supplemented orally in capsule form, at a dose of 3-5 g/day for a period of between 3 and 6 days. A number of exercise performance-enhancing alterations have been reported to occur with sodium phosphate supplementation, which include an increased aerobic capacity, increased peak power output, increased anaerobic threshold and improved myocardial and cardiovascular responses to exercise. A range of mechanisms have been posited to account for these ergogenic effects. These include enhancements in 2,3-Diphosphoglycerate (2,3-DPG) concentrations, myocardial efficiency, buffering capacity and adenosine triphosphate/phosphocreatine synthesis. Whilst there is evidence to support the ergogenic benefits of sodium phosphate, many studies researching this substance differ in terms of the administered dose and dosing protocol, the washout period employed and the fitness level of the participants recruited. Additionally, the effect of gender has received very little attention in the literature. Therefore, the purpose of this review is to critically examine the use of sodium phosphate as an ergogenic aid, with a focus on identifying relevant further research.
Curran MP, Plosker GL. Oral sodium phosphate solution: a review of its use as a colorectal cleanser. Drugs. 2004;64(15):1697-714. doi: 10.2165/00003495-200464150-00009.
Abstract. Oral sodium phosphate solution (Fleet Phospho-soda, Casen-Fleet Fosfosoda is a low-volume, hyperosmotic agent used as part of a colorectal-cleansing preparation for surgery, x-ray or endoscopic examination. The efficacy and tolerability of oral sodium phosphate solution was generally similar to, or significantly better than, that of polyethylene glycol (PEG) or other colorectal cleansing regimens in patients preparing for colonoscopy, colorectal surgery or other colorectal-related procedures. Generally, oral sodium phosphate solution was significantly more acceptable to patients than PEG or other regimens. The use of this solution should be considered in most patients (with the exception of those with contraindications) requiring colorectal cleansing. PHARMACOLOGICAL PROPERTIES: After the first and second 45 mL dose of oral sodium phosphate solution, the mean time to onset of bowel activity was 1.7 and 0.7 hours and the mean duration of activity was 4.6 and 2.9 hours. Bowel activity ceased within 4 hours of administration of the second dose in 83% of patients. Elevations in serum phosphorus and falls in serum total and ionised calcium from baseline occurred during the 24 hours after administration of oral sodium phosphate solution in seven healthy volunteers. These changes were not associated with significant changes in clinical assessments. The decrease in serum potassium levels after administration of oral sodium phosphate solution was negatively correlated with baseline intracellular potassium levels. Therapeutic use: A regimen that administered the first dose of sodium phosphate on the previous evening and a second dose on the morning of the procedure (10-12 hours apart) was significantly more effective than PEG-based regimens for colorectal cleansing in preparation for colonoscopy, sigmoidoscopy or colorectal surgery. A regimen that administered both doses of oral sodium phosphate on the day prior to the procedure offered no colorectal cleansing advantage over PEG-based regimens and was significantly less effective than an oral sodium phosphate solution regimen that administered one dose on the previous evening and a second dose on the morning of the procedure. Oral sodium phosphate solution was generally as effective as other colorectal cleansing solutions (including magnesium citrate-containing regimens with sodium picosulfate). The direct costs of a diagnostic colonic examination with oral sodium phosphate solution were less than those with PEG (US465 dollars vs US503 dollars per patient; 1995 values), according to data from a US study. Oral sodium phosphate solution was significantly more effective than a commercially available tablet formulation as a colorectal cleanser prior to colonoscopy (data from one study only). Tolerability: Oral sodium phosphate solution administered as two 45 mL doses (generally 10-12 hours apart) was well tolerated in well designed trials in which adults with major comorbid conditions were excluded. Sodium phosphate-associated adverse events were mostly gastrointestinal (including abdominal pain/cramping, abdominal fullness and/or bloating, anal or perianal irritation or soreness, nausea, vomiting or hunger pains), although dizziness, weakness/fatigue, thirst, chest pain, chills, headache and sleep loss were also reported. Faecal incontinence was commonly reported in the elderly. Three doses (administered 10 minutes apart) of 15 mL of oral sodium phosphate solution, each diluted in 250 mL of clear fluid was associated with less vomiting than one 45 mL dose of the solution diluted in 250 mL of clear fluid (data from one study). In patients without major comorbid conditions, oral sodium phosphate has been associated with transient and clinically inconsequential changes in intravascular volume and electrolyte disturbances. Serious electrolyte disturbances have been associated with oral sodium phosphate administration in patients in whom sodium phosphate is contraindicated or should be use with caution (the elderly and those with bowel obstructions, small intestinal disorders, poor gut motilderly and those with bowel obstructions, small intestinal disorders, poor gut motility, renal insufficiency, cardiovascular disease or taking concomitant medication) or in patients ingesting more than the recommended dosage. Changes in the colonic mucosa have been reported in patients treated with oral sodium phosphate solution; however, the exact role of this agent in the appearance of these changes has not been fully clarified. The tolerability profile of oral sodium phosphate solution was similar to, or significantly better than, that of PEG or other colorectal cleansing regimens. Oral sodium phosphate solution was generally significantly more acceptable than PEG or other colorectal cleansing regimens. Oral sodium phosphate solution had similar tolerability, but was considered to be more acceptable than commercially available oral sodium phosphate tablets prior to colonoscopy (data from one study).
Cheng J, Tao K, Shuai X, Gao J. Sodium phosphate versus polyethylene glycol for colonoscopy bowel preparation: an updated meta-analysis of randomized controlled trials. Surg Endosc. 2016 Sep;30(9):4033-41. doi: 10.1007/s00464-015-4716-6.
Abstract. Background: Adequate bowel cleansing is of great importance for a high-quality colonoscopy examination. Nevertheless, whether sodium phosphate or polyethylene glycol is a gold standard agent for bowel preparation is still under debate. In consideration of the clinical needs, we thus performed an updated meta-analysis of randomized controlled trials concerning the comparison between both regimens. The efficacy, safety and acceptability of each regimen are major indicators to measure and appraise. Methods: By searching PubMed, EMBASE, Web of Science and Cochrane Library databases, 15 original trials published from 2000 to 2014 were included as eligible studies. We carried out data extraction and subsequent pooling analysis for each indicator in a standard manner. Sensitivity analysis was performed by elimination of low-quality trials, while a funnel plot and Egger's test were employed to analyze the publication bias across studies. Results: Our pooling analysis revealed that patients undergoing sodium phosphate as a cleansing agent displayed better acceptability, compliance, cleansing scores, preparation taste, polyp detection rate and less adverse effects including nausea, vomiting and abdominal pain (P < 0.05). In terms of procedure time, adequate preparation rate and electrolyte concentration, there was no significant difference between both regimens (P > 0.05). The pooling analysis offered stable conclusions which were verified by our sensitivity analysis. There was no publication bias across studies as a symmetric funnel plot was demonstrated and the result of Egger's test was P = 0.56. Conclusions: Regarding preparation efficacy, safety and acceptability, sodium phosphate was a better agent than polyethylene glycol for colonoscopy bowel cleansing, with its advantages of higher efficacy, better tolerability and acceptability as well as comparable safety.
Hoffmanová I, Kraml P, Anděl M. Renal risk associated with sodium phosphate medication: safe in healthy individuals, potentially dangerous in others. Expert Opin Drug Saf. 2015 Jul;14(7):1097-110. doi: 10.1517/14740338.2015.1044970.
Abstract. Introduction: Sodium phosphate purgatives are used for bowel preparation before endoscopic or radiologic examination and occasionally for treatment of severe obstipation. Generally, they are well tolerated and effective; however, safety concerns exist regarding serious renal injury and electrolyte disturbances after administration of these drugs. Areas covered: The review presents complications associated with the use of agents containing sodium phosphate with regard to electrolyte disorders and renal impairment, namely acute phosphate nephropathy (APhN). This paper discusses the pathophysiology, histopathological findings, clinical symptoms, diagnosis and treatment of APhN. Additionally, it examines the epidemiology of adverse renal events and the safety of using sodium phosphate preparations prior to colonoscopy. Expert opinion: Because of safety concerns, sodium phosphate purgatives are not recommended for routine bowel cleansing. Despite some serious and even fatal adverse events associated with these drugs when used with at-risk patients, available data suggest that administration of sodium phosphate purgatives is relatively safe in nonrisk individuals(i.e., in adequately hydrated, otherwise healthy adults, younger than 55 years with evidence of normal renal function).