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A gentle, highly compatible surfactant that is effective on even the most sensitive of skin types. This gentle, easy-to-handle surfactant is suitable for even the most sensitive of skin types, and can be applied to several daily cleansing formulations for it. For further information, including best before dates, please check the Certificate of Analysis (CofA) which can be accessed by clicking on the 'attachments' tab for this product. UK express orders received and paid before 12pm GMT Monday - Thursday will be dispatched same day for next-business-day delivery. Please allow up to two (2) business days for UK mainland delivery when choosing our UK Express Delivery option and up to three (3) business days when choosing UK Economy Delivery. We are unable to offer a nominated delivery date for delivery and will not hold orders in our warehouse. A family-owned business located in central Scotland which offers a diverse range of wholesale soap and cosmetic ingredients to customers throughout the UK and Europe.
Pamidronate Disodium is a sterile bone-resorption inhibitor available in 30 mg, 60 mg, or 90 mg vials for intravenous administration.
CLINICAL PHARMACOLOGYThe principal pharmacologic action of pamidronate disodium is inhibition of bone resorption. Cancer patients (n=24) who had minimal or no bony involvement were given an intravenous infusion of 30, 60, or 90 mg of pamidronate disodium over 4 hours and 90 mg of pamidronate disodium over 24 hours (Table 1).
The mean ± SD body retention of pamidronate was calculated to be 54 ± 16% of the dose over 120 hours. After administration of 30, 60, and 90 mg of pamidronate disodium over 4 hours, and 90 mg of pamidronate disodium over 24 hours, an overall mean ± SD of 46 ± 16% of the drug was excreted unchanged in the urine within 120 hours. There are no data available on the effects of age, gender, or race on the pharmacokinetics of pamidronate.
The pharmacokinetics of pamidronate were studied in cancer patients (n=19) with normal and varying degrees of renal impairment.
Figure 1: Pamidronate renal clearance as a function of creatinine clearance in patients with normal and impaired renal function. The pharmacokinetics of pamidronate were studied in male cancer patients at risk for bone metastases with normal hepatic function (n=6) and mild to moderate hepatic dysfunction (n=7). After intravenous administration of radiolabeled pamidronate in rats, approximately 50% to 60% of the compound was rapidly adsorbed by bone and slowly eliminated from the body by the kidneys. Serum phosphate levels have been noted to decrease after administration of pamidronate disodium, presumably because of decreased release of phosphate from bone and increased renal excretion as parathyroid hormone levels, which are usually suppressed in hypercalcemia associated with malignancy, return toward normal. Osteoclastic hyperactivity resulting in excessive bone resorption is the underlying pathophysiologic derangement in metastatic bone disease and hypercalcemia of malignancy.
In humoral hypercalcemia, osteoclasts are activated and bone resorption is stimulated by factors such as parathyroid-hormone-related protein, which are elaborated by the tumor and circulate systemically.
Extensive invasion of bone by tumor cells can also result in hypercalcemia due to local tumor products that stimulate bone resorption by osteoclasts.
Total serum calcium levels in patients who have hypercalcemia of malignancy may not reflect the severity of hypercalcemia, since concomitant hypoalbuminemia is commonly present. In a third multicenter, randomized, parallel double-blind trial, a group of 69 cancer patients with hypercalcemia was enrolled to receive 60 mg of pamidronate disodium as a 4- or 24-hour infusion, which was compared to a saline-treatment group.
By day 7 after initiation of treatment, 78%, 61%, and 22% of the patients had normal-corrected serum calcium levels for the 60 mg 4-hour infusion, 60 mg 24-hour infusion, and saline infusion, respectively.
For responders, the median duration of complete responses was 4 days and 6.5 days for pamidronate disodium 60 mg 4-hour infusion and pamidronate disodium 60 mg 24-hour infusion, respectively. In all three trials, patients treated with pamidronate disodium had similar response rates in the presence or absence of bone metastases. Thirty-two patients who had recurrent or refractory hypercalcemia of malignancy were given a second course of 60 mg of pamidronate disodium over a 4- or 24-hour period. Paget’s disease of bone (osteitis deformans) is an idiopathic disease characterized by chronic, focal areas of bone destruction complicated by concurrent excessive bone repair, affecting one or more bones. In one double-blind clinical trial, 64 patients with moderate to severe Paget’s disease of bone were enrolled to receive 5 mg, 15 mg, or 30 mg of pamidronate disodium as a single 4-hour infusion on 3 consecutive days, for total doses of 15 mg, 45 mg, and 90 mg of pamidronate disodium. No statistically significant differences between treatment groups, or statistically significant changes from baseline were observed for the bone pain response, mobility, and global evaluation in the 45 mg and 90 mg groups.
Twenty-five patients who had Paget’s disease were retreated with 90 mg of pamidronate disodium. Osteolytic bone metastases commonly occur in patients with multiple myeloma or breast cancer. These bone changes can result in patients having evidence of osteolytic skeletal destruction leading to severe bone pain that requires either radiation therapy or narcotic analgesics (or both) for symptomatic relief.
In a double-blind, randomized, placebo-controlled trial, 392 patients with advanced multiple myeloma were enrolled to receive pamidronate disodium or placebo in addition to their underlying antimyeloma therapy to determine the effect of pamidronate disodium on the occurrence of skeletal-related events (SREs).
In addition, decreases in pain scores from baseline occurred at the last measurement for those pamidronate disodium patients with pain at baseline (P=.026) but not in the placebo group.
After 21 months, the proportion of patients experiencing any skeletal event remained significantly smaller in the pamidronate disodium group than the placebo group (P=.015).

Two double-blind, randomized, placebo-controlled trials compared the safety and efficacy of 90 mg of pamidronate disodium infused over 2 hours every 3 to 4 weeks for 24 months to that of placebo in preventing SREs in breast cancer patients with osteolytic bone metastases who had one or more predominantly lytic metastases of at least 1 cm in diameter: one in patients being treated with antineoplastic chemotherapy and the second in patients being treated with hormonal antineoplastic therapy at trial entry.
382 patients receiving chemotherapy were randomized, 185 to pamidronate disodium and 197 to placebo.
Pain and analgesic scores, ECOG performance status and Spitzer quality of life index were measured at baseline and periodically during the trials. Decreases in pain, analgesic scores and ECOG PS, and increases in Spitzer QOL indicate an improvement from baseline.
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It produces a high quality foam without being hindered by oil, making it widely compatible with a range of pre-existing formulations without having to change a thing.
The pamidronate disodium obtained by combining pamidronic acid and sodium hydroxide is provided in a sterile, ready to use solution for injection.
Its molecular formula is C3 H9 NO7 P2 Na2 and its molecular weight is 279.1 (calculated as the anhydrous form).
Although the mechanism of antiresorptive action is not completely understood, several factors are thought to contribute to this action. Phosphate therapy was administered in 30% of the patients in response to a decrease in serum phosphate levels. These changes occur within the first week after treatment, as do decreases in serum calcium levels, and are consistent with an antiresorptive pharmacologic action.
Excessive release of calcium into the blood as bone is resorbed results in polyuria and gastrointestinal disturbances, with progressive dehydration and decreasing glomerular filtration rate. A few less-common malignancies, including vasoactive intestinal-peptide-producing tumors and cholangiocarcinoma, have a high incidence of hypercalcemia as a metabolic complication. Humoral hypercalcemia usually occurs in squamous-cell malignancies of the lung or head and neck or in genitourinary tumors such as renal-cell carcinoma or ovarian cancer. Tumors commonly associated with locally mediated hypercalcemia include breast cancer and multiple myeloma. Ideally, ionized calcium levels should be used to diagnose and follow hypercalcemic conditions; however, these are not commonly or rapidly available in many clinical situations.
The majority of patients (64%) had decreases in albumin-corrected serum calcium levels by 24 hours after initiation of treatment. Thirty patients were randomized to receive pamidronate disodium and 35 to receive etidronate disodium. At day 14, 39% of the patients in the pamidronate disodium 60 mg 4-hour infusion group and 26% of the patients in the pamidronate disodium 60 mg 24-hour infusion group had normal-corrected serum calcium levels or maintenance of a partial response. These changes result in thickened but weakened bones that may fracture or bend under stress. The median time to response (? 50% decrease) for serum alkaline phosphatase was approximately 1 month for the 90 mg group, and the response duration ranged from 1 to 372 days. These cancers demonstrate a phenomenon known as osteotropism, meaning they possess an extraordinary affinity for bone. These changes also cause pathologic fractures of bone in both the axial and appendicular skeleton.
SREs were defined as episodes of pathologic fractures, radiation therapy to bone, surgery to bone, and spinal cord compression. 372 patients receiving hormonal therapy were randomized, 182 to pamidronate disodium and 190 to placebo. The statistical significance of these analyses may be overestimated since numerous analyses were performed.
The complete + partial response rate was 33% in pamidronate disodium patients and 18% in placebo patients treated with chemotherapy (P=.001). Working well in a lower pH range of between 4 and 9, Disodium Cocoamphodiacetate has an incredibly high resistance to hard water, working effectively even in salt water. Pamidronate disodium adsorbs to calcium phosphate (hydroxyapatite) crystals in bone and may directly block dissolution of this mineral component of bone. The renal clearance of pamidronate in patients was found to closely correlate with creatinine clearance (see Figure 1). Although there was a statistically significant difference in the pharmacokinetics between patients with normal and impaired hepatic function, the difference was not considered clinically relevant. Studies in rats injected with radiolabeled pamidronate disodium showed that the compound was rapidly cleared from the circulation and taken up mainly by bones, liver, spleen, teeth, and tracheal cartilage. This, in turn, results in increased renal resorption of calcium, setting up a cycle of worsening systemic hypercalcemia.
Patients who have hypercalcemia of malignancy can generally be divided into two groups, according to the pathophysiologic mechanism involved.

Therefore, adjustment of the total serum calcium value for differences in albumin levels is often used in place of measurement of ionized calcium; several nomograms are in use for this type of calculation (see DOSAGE AND ADMINISTRATION). Mean-corrected serum calcium levels at days 2 to 7 after initiation of treatment with pamidronate disodium were significantly reduced from baseline in all three dosage groups.
Patients were not required to receive IV hydration prior to drug administration, but all subjects did receive at least 500 mL of IV saline hydration concomitantly with the pamidronate infusion.
The distribution of osteolytic bone metastases in these cancers is predominantly in the axial skeleton, particularly the spine, pelvis, and ribs, rather than the appendicular skeleton, although lesions in the proximal femur and humerus are not uncommon. Axial skeletal fractures of the vertebral bodies may lead to spinal cord compression or vertebral body collapse with significant neurologic complications.
Patients received either 90 mg of pamidronate disodium or placebo as a monthly 4-hour intravenous infusion for 9 months. Fewer pamidronate disodium patients suffered vertebral pathologic fractures (16% vs 27%, P=.005). No difference was seen between pamidronate disodium and placebo in hormonally-treated patients. Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death.
It is compatible with anionic, non-ionic and amphoteric surfactants, thus adding to it's high-compatibility and easy-to-use factors. In vitro studies also suggest that inhibition of osteoclast activity contributes to inhibition of bone resorption.
A trend toward a lower percentage of drug excreted unchanged in urine was observed in renally impaired patients.
Patients with hepatic impairment exhibited higher mean AUC (53%) and Cmax (29%), and decreased plasma clearance (33%) values. Correction of excessive bone resorption and adequate fluid administration to correct volume deficits are therefore essential to the management of hypercalcemia.
As a result, by 7 days after initiation of treatment with pamidronate disodium, 40%, 61%, and 100% of the patients receiving 30 mg, 60 mg, and 90 mg of pamidronate disodium, respectively, had normal-corrected serum calcium levels. At day 14, 43% of patients in the pamidronate disodium group and 18% of patients in the etidronate disodium group still had normal-corrected serum calcium levels, or maintenance of a partial response.
This distribution is similar to the red bone marrow in which slow blood flow possibly assists attachment of metastatic cells. Of the 392 patients, 377 were evaluable for efficacy (196 pamidronate disodium, 181 placebo). As it is compatible with both the skin and the mucous membrane, it can also be used in gentle hair and facial cleansers without causing dryness or irritation, making it excellent for leave in conditioners as well as facial cleansers and scrubs. In animal studies, at doses recommended for the treatment of hypercalcemia, pamidronate disodium inhibits bone resorption apparently without inhibiting bone formation and mineralization. Adverse experiences noted were not found to be related to changes in renal clearance of pamidronate. Many patients (33% to 53%) in the 60 mg and 90 mg dosage groups continued to have normal-corrected serum calcium levels, or a partial response (? 15% decrease of corrected serum calcium from baseline), at day 14. For responders in the pamidronate disodium and etidronate disodium groups, the median duration of response was similar (7 and 5 days, respectively). The surface-to-volume ratio of trabecular bone is much higher than cortical bone, and therefore disease processes tend to occur more floridly in trabecular bone than at sites of cortical tissue. Median duration of follow-up was 13 months in patients receiving chemotherapy and 17 months in patients receiving hormone therapy. Disodium Cocoamphodiacetate is added during the final stage of a cosmetic formulation for best results. Of relevance to the treatment of hypercalcemia of malignancy is the finding that pamidronate disodium inhibits the accelerated bone resorption that results from osteoclast hyperactivity induced by various tumors in animal studies. Given the recommended dose, 90 mg infused over 4 hours, excessive accumulation of pamidronate in renally impaired patients is not anticipated if pamidronate disodium is administered on a monthly basis. The terminal phase of elimination half-life in bone was estimated to be approximately 300 days. Twenty five percent of the patients in the chemotherapy study and 37% of the patients in the hormone therapy study received pamidronate disodium for 24 months. Pamidronate, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Because pamidronate disodium is administered on a monthly basis, drug accumulation is not expected.
No changes in pamidronate disodium dosing regimen are recommended for patients with mild to moderate abnormal hepatic function.

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