Villi S. Toddywalla

RELEASE OF 19-NOR-TESTOSTERONE TYPE OF CONTRACEPTIVE STEROIDS THROUGH DIFFERENT DRUG DELIVERY SYSTEMS INTO SERUM AND BREAST MILK OF LACTATING WOMEN

The release of contraceptive steroids through different drug delivery systems into serum and breast milk was investigated in a group of lactating women. Four women in each group were taking either a low dosage progestogen compound like norethisterone (NET) 350 micrograms or d-norgestrel (d-Ng) 50 micrograms alone or low dosage combination pills containing NET 1 mg or d-Ng 150 micrograms with 30 micrograms ethinyl estradiol (EE2) or a biodegradable implant containing 25 mg NET or d-Ng. Peak levels in plasma and milk were seen in oral contraceptive users around 2 hours. Of the two low dosage progestogen compounds, d-Ng was below the detection limit in milk within 4 hours whereas NET was still detectable at the 24-hour interval. In contrast to this, because of the larger quantity of steroids in the combination pills, the NET/d-Ng levels in serum as well as in milk were high throughout the 24-hour period. With the subdermal route because of the sustained low release of the drug from the biodegradable implants, the levels in milk were below the detection limit within a day with d-Ng and within a week with NET.

A sensitive ELISA for 6β-hydroxycortisol in urine using enzyme penicillinase (β-lactamase)

Abstract A sensitive and specific, enzyme labelled immunosorbent assay (ELISA) for 6β-hydroxycortisol in diluted urine using penicillinase was developed. 6β-Hydroxycortisol-21-hemisuccinate was conjugated with enzyme penicillinase. Antibody immobilized on a polyvinylchloride ELISA plate (Dynatech) was used for separation of bound from free ligand. The sensitivity of the assay was between 2.0–3.0 pg per well and recovery of 6β-hydroxycortisol from urine ranged between 85.0–108.0%. The assay is simple, rapid and precise.

Reproductive endocrine effects of intranasal administration of norethisterone (NET) to women

Four consecutive menstrual cycles were studied in six healthy parous women. A solvent mixture comprising propylene glycol:ethanol:water (3:3:4) was sprayed intranasally daily using a glass atomizer between days 5 and 24 of the first (control) menstrual cycle. NET was dissolved in the solvent and similarly administered at a daily dose of 100 mcg during the second and third menstrual cycles. Nasal sprays were not administered during the fourth post-treatment cycle. Blood samples were taken during four consecutive cycles between days 8 and 15 and again between days 20 and 24 of the cycle to estimate levels of estradiol (E2), FSH, LH and progesterone (P). These studies revealed that nasal sprays of NET were well accepted and that no adverse clinical effects or menstrual disturbances occurred. NET inhibited ovulation in one cycle. The E2-induced mid-cycle rise in FSH and LH was either suppressed or inhibited in nine out of the 12 treated cycles. P levels in three treated cycles were indicative of luteal inadequacy. These endocrine effects of NET persisted into the post-treatment cycle in two cases.

A nomogram of the neonatal peak of urinary follicle stimulating hormone, luteinizing hormone and testosterone in normal male infants

Daily urinary follicle stimulating hormone (FSH), luteinizing hormone (LH) and testosterone (T) levels were estimated in a group of 10 normal one month old male infants. Four-hourly urine samples were collected from each infant over a three months period i.e., from one month to four months of infants age. The hormonal levels were expressed as mIU of FSH, LH and ng of T per mg creatinine. The normal hormonal pattern thus obtained could be used to compare patterns obtained from pathological cases or when monitoring the effects of drugs on infants.