Suzhou Pharmaserve Technology Co., Ltd.

What is Oxytocin?

Oxytocin is a natural human hormone that is secreted by the hypothalamus and stored in the pituitary gland. It has several FDA approved indications, with labor induction being the most common use. It is available commercially as oxytocin 10 Unit/mL solution for injection. Oxytocin has also been studied for many off label uses as well, including intractable pain, autism, fibromyalgia, migraine, social anxiety, sexual dysfunction, weight loss and vaginal atrophy. The most common dosage forms used in compounding are intranasal, sublingual and vaginal preparations. It is important to note that oxytocin is sensitive to heat and should not be formulated in dosage forms such as rapid dissolve tablets or troches that require heat to make the final product.

Introduction

Every year, an estimated 94 000 women die due to bleeding complications related to pregnancy and childbirth. Postpartum haemorrhage (PPH) remains the leading direct cause of maternal mortality worldwide, representing 27.1% of all maternal deaths. The use of uterotonics plays an important role in the prevention and treatment of PPH. Oxytocin is recommended by the World Health Organization (WHO) as the uterotonic drug of choice for the prevention and treatment of PPH This disease is predominantly caused by lifestyle factors like overweight and obesity. The key feature on type 2 diabetes is the presence of insulin resistance which reduced the capacity of insulin to exert its functions at normal at any given concentration. The secretion of insulin is stimulated by the action of incretins in the gut like glucagon-like peptide 1, which also delays gastric emptying and induces satiety, and glucose-dependent insulinotropic polypeptide.

Usage

1. Induced labour 2. Strengthen uterine contractions: During childbirth, if uterine contractions are weak, uterine contractions need to be strengthened. 3. Prevention and treatment of postpartum hemorrhage in mothers. Oxytocin is included in the WHO Essential Medicines list, as well as in the United Nation Commission on Life-Saving Commodities for Women and Children (UNCoLSC) list. Oxytocin is widely available in low- and middle-income countries (LMIC).

How to select high quality Oxytocin

The quality of medicines includes many aspects directly related to the product itself (e.g. appearance, volume, pH, pharmaceutical content, sterility, related substances, contaminants, solubility), as well as aspects related to packaging, labelling, transportation and storage conditions of the product, including light, humidity and temperature of the area where the product is kept. However, we focus on two main aspects of oxytocin quality, namely active pharmacological ingredient (API) and sterility, essential attributes of this injectable thermolabile drug, that are also the most frequently reported in primary studies on medicine quality. According to the International Pharmacopoeia, oxytocin injections should contain not less than 90% and not more than 110% of the amount of oxytocin (C43H66N12O12S2) stated on the label and should be sterile. These limits are also used by the British Pharmacopoeia and US Pharmacopeia. Therefore, for all these pharmacopoeias as well as for regulatory authorities and manufacturers that registered these limits, products containing less than 90.0% or over 110% oxytocin would be considered substandard and not to be used in treatment.

Storage

Oxytocin Pharmaserve needs to be stored under refrigeration (2–8°C) as much as possible, although short periods of unrefrigerated transport not exceeding 1 month at 30°C or 2 weeks at 40°C, are acceptable.5 Oxytocin should also not be frozen, although recent evidence suggests that multiple cycles of freezing and thawing do not significantly change oxytocin content.

Pharmaserve's SPPS for Oxytocin

Chemical synthesis methods mainly include liquid phase method and solid phase method. The oxytocin synthesized by liquid phase method has more impurities, which may increase the risk of allergic reactions. Studies have shown that the purity of oxytocin produced by solid phase peptide synthesis method can be as high as 99%. The biological extraction process has also undergone major technological reforms. The purity of oxytocin extracted by a new biological extraction process combining membrane technology and resin purification technology can reach more than 90%. However, since the raw materials are derived from the pig pituitary gland, they inevitably contain pressor antidiuretic hormone and high molecular weight substances with a molecular weight greater than 5000. Large doses may cause increased blood pressure and antidiuretic effects, and high molecular weight substances have a certain correlation with allergic reactions caused by oxytocin. There are few domestic reports on the comparative bioequivalence of drugs from the two sources, all of which suggest that biologically extracted oxytocin injection may be superior to chemically synthesized oxytocin injection. In summary, in this study, there was no significant difference in the efficacy and safety of oxytocin injections from different sources produced by the two manufacturers. In terms of economy, chemically synthesized preparations were obviously superior to biologically extracted preparations, suggesting that under the premise of ensuring the therapeutic effect, the use of chemically synthesized oxytocin is more cost-effective!

Research Progress on the Oxytocin-the "love hormone"As more and more research is done on oxytocin, our understanding of it is also becoming more and more in-depth. Studies have shown that the function of oxytocin is not only to promote lactation and uterine contraction, but also to have a certain impact on people’s social behavior, such as making people get along well, “keeping love fresh”, and it is expected to be used to treat drug addiction and some mental illnesses. Therefore, the use of oxytocin will increase in the future, and the demand will increase.Recent studies have begun to explore the effects of oxytocin on various social behaviors of animals or humans. It has many complex functions, such as helping mothers to establish a connection with their babies, active social interactions, and may accelerate wound healing. Oxytocin gives people a sense of contentment, reduces anxiety in animals or humans, and increases a sense of calmness and security in their spouses. For this reason, it is sometimes called the “love hormone”.Oxytocin has a certain relationship with animal memory and cognition. Scholars have shown that oxytocin distributed in different parts has different effects. For example, oxytocin in the amygdala has a certain effect on social cognition and mood anxiety; oxytocin distributed in the hypothalamus mainly affects the sexual behavior of animals; oxytocin in the hippocampus can reduce memory. For this reason, oxytocin is also called “forgetfulness peptide”. This property can explain from another perspective that it helps to reduce the pain of childbirth for mothers.