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Night Sweats in Diabetes and Compounding

Night sweats in diabetic patients and magistral treatment optionsSweating is a physiological part of body temperature regulation. However, excessive sweating of the face and head region, and even the flushing that accompanies sweating, is a condition that can negatively affect social relationships and even cause social phobia. Excessive facial sweating, particularly forehead sweating, can adversely affect visual function due to the irritation of sweat in the eyes. In these individuals, psychological problems can sometimes deepen further when this condition remains unresolved. For this reason, due to anxiety over flushing and sweating, patients do not want to enter any social environment and have difficulty concentrating. Excessive facial sweating also brings the problem of odor. Negatively impacting their lives, this condition can truly be uncomfortable and distressing. Depression and social phobia can develop.

Eccrine sweat glands are responsible for excessive sweating—hyperhidrosis—in the face and head area, and they are stimulated cholinergically by sympathetic nerves. After the feet, per cm2, with 360 eccrine sweat glands, the forehead is the area on the face where excessive sweating is most commonly seen. In hyperhidrosis, it has been determined that there is no qualitative or quantitative change in the eccrine sweat glands in the skin. Hyperhidrosis is thought to result from overactivity of the sympathetic system. A malfunction of the hypothalamus and the receptors responsible for thermoregulation in the skin and body plays a role in this.night sweats in diabetic patients:In diabetic patients using insulin or oral antidiabetic medications, night sweats occur accordingly at night. It manifests with a drop in blood glucose levels. Night sweats are prominently and frequently observed in diabetic patients. It is observed at a rate of 69% in diabetic patients secondary to neuropathies.

As a precaution; a light, protein-rich snack should be consumed before going to bed at night. The snack may contain 30-60 grams of protein and 15-30 grams of carbohydrates. Because the liver processes protein slowly, an adequate supply of glucose to the body will be maintained throughout the night. In this way, you can naturally manage night sweats. Measuring and recording blood sugar regularly in the middle of the day—for instance, around two in the afternoon—will help identify what influences your blood sugar during the day, significantly increasing your chances of keeping night sweats under control.

Gustatory sweating is facial sweating that occurs upon the ingestion of food or drink; it is a rare but recognized complication of Diabetes Mellitus. Diabetes-related gustatory sweating is sometimes closely associated with diabetic nephropathy. While sweating in diabetic patients is bilateral, sweating in Frey syndrome, which develops following parotidectomy or facial nerve dissection during head and neck surgery, is unilateral.

Frey’s Syndrome;Frey syndrome is a specific form of gustatory hyperhidrosis. Several weeks to months following parotid gland surgery, trauma, abscess, or other conditions (such as shingles), vasodilation and sweating develop on the cheek and neck in response to stimuli that provoke salivary secretion, such as eating, drinking, and chewing. Sweating is most commonly observed on the face in the area innervated by the auriculotemporal nerve. It occurs due to aberrant regeneration of parasympathetic nerves following standard or tumor surgery of the parotid or salivary glands. It can occur in up to 40% of patients following parotid gland surgery. Additionally, it may occur in newborns following forceps-assisted deliveries.

Initial treatment approaches focused on the use of topical scopolamine; however, concerns were raised regarding systemic absorption potentially causing severe central nervous system side effects. Various treatments have been attempted, including topical glycopyrrolate and intracutaneous injection of botulinum toxin type A. Both treatments have been reported to be highly effective.

Topical glycopyrrolate 0.5% preparations included in the United States National Formulary have been used in the treatment of diabetic sweating and Frey syndrome.Formula:

 

                                     Cream                       Ointment

Glycopyrrolate          500 mg                  500 mg

Emulsion Base          99.5 mg

Polyethylene Glycol Ointment                99.5 g

 

Ingredients in the formula:

Glycopyrrolate – Glycopyrronium bromide – Glycopyrronium bromid [ASK; INN; Ph.Eur.]:Glycopyrrolate is an antimuscarinic, synthetic quaternary ammonium compound used preoperatively to prevent excessive secretions in the respiratory tract and in the treatment of peptic ulcer disease. It is a white, odorless, bitter-tasting crystalline powder. 1 g of the substance dissolves in 4.2 ml of water and 30 ml of alcohol. It is hygroscopic and resistant to heat and light. Its oral and parenteral formulations are indicated for the treatment and prevention of peptic ulcers. However, it is rarely used for this indication due to both potential side effects and the availability of more effective alternative medications. Glycopyrrolate is administered parenterally as a preanesthetic or intraoperative antimuscarinic agent. In addition, intravenous glycopyrrolate is also used for the reversal of neuromuscular blockade. Glycopyrrolate oral solution is used to reduce severe chronic drooling in children and adolescents (3–16 years of age) with certain neurological conditions. Because glycopyrrolate is a quaternary (i.e., charged) compound, it is less likely to penetrate the central nervous system and cause adverse effects compared to atropine or scopolamine. For the same reason, glycopyrrolate should not be used in the treatment of organophosphate insecticide toxicity. In addition, its ionic charge reduces its oral bioavailability, leading to a significant difference between enteral and parenteral doses. Glycopyrrolate was approved by the FDA in 1961. The FDA approved the oral glycopyrrolate solution (Cuvposa) in July 2010. Glycopyrronium bromide was approved by the EMA in August 2012 for use as a maintenance treatment to relieve symptoms of chronic obstructive pulmonary disease in adults.

It is unknown whether glycopyrronium bromide is excreted in human milk. Anticholinergic drugs such as glycopyrrolate may suppress lactation, particularly in the initial period, when used chronically.

Glycopyrrolate is an antimuscarinic, synthetic quaternary ammonium compound used preoperatively to prevent excessive secretions in the respiratory tract and in the treatment of peptic ulcer disease. It is a white, odorless, bitter-tasting crystalline powder. 1 g of the substance dissolves in 4.2 ml of water and 30 ml of alcohol. It is hygroscopic and resistant to heat and light.Emulsion Base:Dermabase cream is an odorless, washable, oil-in-water emulsion-type cream base. It contains purified water, mineral oil, petrolatum, cetostearyl alcohol, propylene glycol, sodium lauryl sulfate, isopropyl palmitate, imidazolidinyl urea, methylparaben, and propylparaben. It is a white, light, pleasantly scented, smooth, water-washable cream.Polyethylene Glycol Ointment:Polyethylene glycol is an addition polymer of ethylene oxide and water. PEGs with a molecular weight between 200–600 are liquids at room temperature, and those with molecular weights above 1000 are solids. Liquid PEGs are clear, colorless or pale yellow, viscous liquids and are light. They have a characteristic odor and a bitter taste. The density of liquid PEGs ranges from 1.11 to 1.14 g/ml. Solid PEGs are white or off-white pastes, waxy flakes, or free-flowing powders. The density of solid PEGs ranges from 1.15 to 1.21 g/ml. PEGs are chemically stable and do not support microbial growth. Physically, PEG bases may soften when mixed with phenol, tannic acid, or salicylic acid.

Polybase is a pre-blended, water-soluble suppository base composed of a homogeneous mixture of PEGs of various molecular weights. It contains PEGs (average molecular weight approximately 3440) and polysorbate 80. It is used in the preparation of suppositories or lozenges where a water-soluble or water-miscible base is preferred. They release medications by dissolving in fluids. It is a white solid with a slight PEG odor and has a specific gravity of 1.177. Products prepared from this base should not be stored or dispensed in polystyrene containers.Formula;

Rp.

Polyethylene Glycol 400     60%

Polyethylene Glycol 3350   40%

Preparation:Heat the mixture of PEG 400 and PEG 3350 on a hot plate to approximately 65 °C.

Remove from the hot plate and stir at room temperature until a homogeneous mixture is formed.Preparation of the formula:The total amount to be prepared must be determined and the quantity of each compound calculated. Weighing must be performed accurately. Glycopyrrolate is geometrically mixed with a water-in-oil based emulsion (Dermabase or Velvachol) or polyethylene glycol ointment until a homogeneous appearance is obtained. It is packaged and labeled.

In conducted studies, a 0.5% glycopyrrolate cream or lotion form was used. The presented cream formulation can be converted into a lotion form by adding distilled water to achieve the desired viscosity prior to the addition of glycopyrrolate.

Packaging

Must be stored in tightly closed containers.

Labeling

For external use only. Keep out of reach of children.

Stability

Cream: Must be used within 14 days from the preparation date. Store in a cool place.

Ointment: Must be used within 30 days from the preparation date.

Wishing you a great week…

References:

1-Allen’s Compounded Formulations

2-RxMediaPharma®2018 Interactive Drug Information SourceSpecialist Pharmacist Ahmet Nezihi Pekcan
Pekcan Pharmacy – Konya
[email protected]
Tel: (332) 3520657
http://www.majistralformul.com/

Association of Expert Pharmacists in
Personalized Medication Production