Effects During Pregnancy and Lactation
◉ Summary of Use during Lactation
Lanolin is a yellow fat obtained from sheep's wool. It has traditionally been used topically to treat sore, cracked nipples during breastfeeding. Highly purified lanolin products (e.g., HPA lanolin, Lansinoh) have the pesticide and detergent residues removed and the natural free alcohols reduced to below 1.5% to improve safety and reduce the allergic potential. However, even highly-purified lanolin should be avoided in patients with a known allergy to wool.
Lanolin appears to be effective for the prevention and treatment of nipple pain during breastfeeding, but not as a preventative initiated before delivery. Studies, most of which used Lansinoh, have not found lanolin to be consistently different in efficacy from application of breastmilk, hydrogel dressings, peppermint gel, aloe vera or warm compresses. A meta-analysis concluded that application of nothing or breastmilk may be superior to lanolin, but good studies are lacking. One small nonblinded study found olive oil to be superior to lanolin for prevention of sore nipples, and another small, single-blinded study found that lanolin application to painful nipples did not decrease nipple pain compared to usual care. A study in women with nipple trauma and pain comparing application of lanolin after each feeding to application of breastmilk plus a nipple shell found that the breastmilk and shell were more effective than lanolin. A randomized study comparing highly purified lanolin (Lansinoh) to expressed breastmilk in 180 mothers, found lanolin to be superior to breastmilk over a 7-day period in reducing pain and the nipple trauma score. Two studies of moderate quality found aloe vera and purslane to be more effective than lanolin in treating sore nipples during breastfeeding.
A study comparing the various highly purified lanolin products found that HPA lanolin (Lansinoh Laboratories Inc.), Purelan (Medela AG) and two lanolin EU monograph compliant ingredients (Pharmalan PH EU-SO-(RB) and Corona-8 SO-(RB) (Croda, Goole, UK). The EU monograph compliant ingredients had the lowest level of contaminants. HPA lanolin contained an extremely low level of free lanolin alcohols, indicating a high level of purification, which was fourfold lower than Purelan. The HPA lanolin did not contain any detectable pesticide residues. Purelan contained a number of pesticide residues (diazinon, piperonyl butoxide, triflumuron); however, the levels were low and within the permitted limits.
◉ Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
◉ Effects on Lactation and Breastmilk
In a randomized, double-bind trial, lanolin was compared to an all-purpose nipple ointment containing mupirocin 1%, betamethasone 0.05%, and miconazole 2% for painful nipples while nursing in the first 2 weeks postpartum. The two treatments were equally effective in reducing nipple pain, nipple healing time, breastfeeding duration, breastfeeding exclusivity rate, mastitis and nipple symptoms, side effects or maternal satisfaction with treatment.
A randomized trial in nursing women with damaged, painful nipples compared lanolin application to usual care, which was a variable mix of education or assistance by health professional, application of warm or cool compresses, analgesics, air drying the nipples or the use of breast shields. A blinded observer assessed healing via telephone calls to the mothers several times after randomization. No differences were found in nipple pain between the groups 4 to 7 days after randomization. No difference was found in breastfeeding self-efficacy at 4 days post-randomization or in the breastfeeding rates of the two groups at 4 and 12 weeks postpartum. Patient satisfaction with care was higher in the women who received lanolin.

[1]. Lanolin. Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006.

Stearyl palmitate appears as white crystals or flakes. (NTP, 1992)
Stearyl palmitate is a palmitate ester resulting from the formal condensation of the carboxy group of palmitic acid with the hydroxy group of stearyl alcohol. It has a role as a cosmetic and a coral metabolite. It is a hexadecanoate ester and a wax ester. It is functionally related to an octadecan-1-ol.
Lanolin has been reported in Bombax ceiba and Triticum aestivum with data available.
See also: Lanolin (annotation moved to).

C34H68O2

508.9025

508.521

8006-54-0

114471-15-7; 8036-05-3;8038-41-3;8038-43-5;8040-96-8; 8006-54-0;

75778

Light yellow to yellow ointment

38-40 ºC

209 ºC

16.3

0

2

32

36

406

0

O(C(C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H])=O)C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H]

BILPUZXRUDPOOF-UHFFFAOYSA-N

InChI=1S/C34H68O2/c1-3-5-7-9-11-13-15-17-18-19-21-23-25-27-29-31-33-36-34(35)32-30-28-26-24-22-20-16-14-12-10-8-6-4-2/h3-33H2,1-2H3

octadecyl hexadecanoate

2934.99.9001

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month

Note: This product requires protection from light (avoid light exposure) during transportation and storage.

Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)

DMSO : ~100 mg/mL (~77.32 mM)

Solubility in Formulation 1: ≥ 2.5 mg/mL (1.93 mM) (saturation unknown) in 10% DMSO + 40% PEG300 + 5% Tween80 + 45% Saline (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 400 μL PEG300 and mix evenly; then add 50 μL Tween-80 to the above solution and mix evenly; then add 450 μL normal saline to adjust the volume to 1 mL.
Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH₂ O to obtain a clear solution.

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Solubility in Formulation 2: ≥ 2.5 mg/mL (1.93 mM) (saturation unknown) in 10% DMSO + 90% (20% SBE-β-CD in Saline) (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 900 μL of 20% SBE-β-CD physiological saline solution and mix evenly.
Preparation of 20% SBE-β-CD in Saline (4°C，1 week): Dissolve 2 g SBE-β-CD in 10 mL saline to obtain a clear solution.

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Solubility in Formulation 3: ≥ 2.5 mg/mL (1.93 mM) (saturation unknown) in 10% DMSO + 90% Corn Oil (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 900 μL of corn oil and mix evenly.

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 (Please use freshly prepared in vivo formulations for optimal results.)