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PubMed1993

Anorectal stenosis in patients with prolonged use of suppositories containing paracetamol and acetylsalicylic acid.

We report five cases in which anorectal stenosis was associated with chronic administration of suppositories containing paracetamol and acetylsalicylic acid. All patients were females taking suppositories for chronic migraine. Patients experienced anal pain, tenesmus, fecal incontinence, and, in two cases, intestinal obstruction. Lesions were characterized by a severe circular narrowing of the distal rectum with superficial ulcerations. Radiographs demonstrated the presence of sinus-tract-like formations in the diseased segment and thickening of the rectal wall. Histologic examination showed signs of chronic inflammation with deep ulcerations associated with obliteration of the lamina propria by a fibromuscular proliferation, as was described in the solitary ulcer syndrome of the rectum. Rectal administration of suppositories was discontinued in all the patients. Two patients were improved by anorectal dilatation, but the remaining three required a left proctocolectomy with subsequent coloanal anastomosis. The use of such suppositories must be restricted.

Acetaminophen↗

PubMed1984

Rectal absorption of metronidazole from polyethylene glycol suppositories.

The rectal absorption of metronidazole from an aqueous suspension, a fatty suppository and three different polyethylene glycol suppositories was studied in healthy volunteers and compared with absorption from an oral solution. Rectal absorption was found to be rather slow for all suppositories. Of all rectal dosage forms, the polyethylene glycol suppositories gave the highest peak plasma levels and the highest relative bioavailability. Compared with oral administration, a relative bioavailability of 80% could be obtained.

Administration, Oral↗

PubMed1994

Regression of rectal polyps by indomethacin suppository in familial adenomatous polyposis. Report of two cases.

PURPOSE: The effect of indomethacin suppository on rectal polyps was evaluated in two patients with familial adenomatous polyposis who had undergone total colectomy and ileoproctostomy. METHODS: Both patients received intrarectal administration of 50 mg of indomethacin suppository once or twice daily to control the rectal remnant polyps. RESULTS: With this treatment, an almost complete regression was achieved within three months, in both patients. Polyps recurred after the interruption of indomethacin treatment in one patient. At the present follow-up of two to three years, no cancer has developed. CONCLUSIONS: Indomethacin suppository treatment was effective in controlling rectal remnant polyps in the two patients with familial adenomatous polyposis. Intraluminal administration of indomethacin in suppository form seems more beneficial since it allows for direct contact of the drug with the lesions and produces a high local concentration of the drug.

Adenomatous Polyposis Coli↗

PubMed2005

Effects of irradiation combined with cis-diamminedichloroplatinum (CDDP) suppository in rabbit VX2 rectal tumors.

To decrease local recurrence and increase disease free survival, various preoperative therapies for patients with advanced rectal cancer have been studied. Cis-diamminedichloroplatinum (II) (CDDP) has become one of the most widely used cancer chemotherapeutic drugs. It has also been found to have radiosensitizing properties. In this experimental study, the efficacy of chemoradiotherapy using a novel CDDP suppository, and one with mixed micelles, was examined in a rabbit VX2 rectal tumor model. Rabbits were divided into four groups: control group, irradiation (R) group, CDDP suppository plus irradiation (CR) group, and mixed micelles plus CDDP suppository plus irradiation (CMR) group. Tumor growth ratios were reduced significantly in the CR and CMR groups as compared with the ratio in the control group. Microscopically, response rates of main tumors were 0%, 33.3%, 70.0%, and 91. 7%, respectively. The number of metastatic lymph nodes in the CR and CMR groups decreased significantly compared to the control group and the R group. The microscopic response rates of metastatic lymph nodes were 0%, 11.1%, 40.0%, and 41.7%, respectively. Lung metastases were observed in three rabbits in the R group, and in one rabbit in the CMR group. Tissue platinum concentrations both in tumors and in regional lymph nodes increased significantly when mixed micelles were used. Chemoradiotherapy using the CDDP suppository and mixed micelles was effective for local control in the rabbit VX2 rectal tumor model.

Animals↗

PubMed1999

Twice-daily versus once-daily morphine sulphate controlled-release suppositories for the treatment of cancer pain. A randomized controlled trial.

We evaluated the safety and efficacy of controlled-release morphine sulphate suppositories administered 12-hourly and once daily in patients with chronic cancer in a randomized double-blind crossover trial. Pain was assessed using a 100-mm VAS pain scale and a five-point ordinal pain scale. The VAS pain intensity score was 17.5+/-17.2 after suppositories every 12 h, versus 16.2+/-13.4 after suppositories every 24 h (difference not significant). The difference between the mean VAS pain scores with 12-hourly and once-daily dosing was 1.3 mm (not significant). The mean ordinal pain scores were 1.0+/-0.7 versus 1.0+/-0.6 for 12-hourly and once-a-day dosing, respectively (not significant). A retrospective power analysis indicated that a difference of 5.9 mm was detectable, even with only 6 patients. Adverse events noted were constipation, nausea, anorexia, and dry mouth. The use of once-a-day controlled-release morphine suppository is a more convenient and equally effective alternative to twice a day dosing.

Aged↗

PubMed1975

Reduction of cervical resistance by prostaglandin suppositories prior to dilatation for induced abortion.

Several recent reports citing increased rates of prematurity among women who have had induced first-trimester abortion suggest that forceful cervical dilatation may result in cervical incompetence in future pregnancy. There appear to be conflicting clinical impressions regarding the effectiveness on cervical softening and the reduction of cervical resistance produced by various prostaglandins. The development of the Electronic Force Monitor which is capable of precise measurement of the forces encountered in overcoming resistance during dilatation provided objective evidence with which to evaluate the effects of vaginally administered prostaglandin E2 and F2alpha suppositories. Suppositories were administered 3 hours prior to cervical dilatation, after which suction curettage was performed. Compared to the nonmedicated control group, patients receiving PGF2alpha suppositories exhibited greatly reduced cervical resistance, in some cases permitting direct introduction of the suction curette without need for any preliminary dilatation. Those patients receiving PGE2 suppositories showed an intermediate degree of cervical softening.

Abortion, Induced↗

PubMed1980

Comparison between naproxen tablets and suppositories in primary dysmenorrhea.

Naproxen tablets and suppositories were compared, in the treatment of primary dysmenorrhea, in a double-blind cross-over trial. The results on 32 patients treated during 128 menstruations with either tablets and suppositories were analysed. Both naproxen tablets and suppositories produced a significant but similar overall relief of dysmenorrhea, although the tablets had a better effect in relieving spasmodic pain than the suppositories (p < 0.05). Occasions of failure to obtain relief were not related to the occurrence of vomiting or diarrhea during the trial. Vomiting seems not to be responsible for the therapeutic failures of oral treatments with prostaglandin-synthetase inhibitors in primary dysmenorrhea.

Adolescent↗

PubMed1991

Rectal suppository: commonsense and mode of insertion.

Rectal suppository is a well-known form of medication and its use is increasing. The commonest shape is one with an apex (pointed end) tapering to a base (blunt end). Because of a general lack of information about mode of insertion, we asked 360 lay subjects (Egyptians and non-Egyptians) and 260 medical personnel (physicians, pharmacists, and nurses) by questionnaire which end they inserted foremost. Apart from 2 individuals, all subjects suggested insertion with the apex foremost. Commonsense was the most frequent basis for this practice (86.9% of lay subjects and 84.6% of medical personnel) followed by information from a relative, a friend, or medical personnel, or from study at medical school. Suppository insertion with the base or apex foremost was compared in 100 subjects (60 adults, 40 infants and children). Retention with the former method was more easily achieved in 98% of the cases, with no need to introduce a finger in the anal canal (1% vs 83%), and lower expulsion rate (0% vs 3%). The designer of the "torpedo-shaped" suppository suggested its insertion with apex foremost. Our data suggest that a suppository is better inserted with the base foremost. Reversed vermicular contractions or pressure gradient of the anal canal might press it inwards.

Adult↗

PubMed2006

A gradient HPLC method for the quality control of chlorogenic acid, linarin and luteolin in Flos Chrysanthemi Indici suppository.

The Flos Chrysanthemi Indici suppository, a famous traditional Chinese medicine, is marketed for the treatment of prostatitis and chronic pelvic inflammation. A simple, relatively rapid and accurate high-performance liquid chromatographic (HPLC) method was applied to the simultaneous determination of chlorogenic acid, linarin and luteolin in Flos Chrysanthemi Indici suppository. The good separation was achieved on a Hypersil ODS column by a gradient elution using the mixture of acetonitrile and aqueous 1.0% acetic acid as mobile phase within 23 min. The method was validated for three active phenolic compounds with the relative standard deviations (R.S.D.) of intra- and inter-day precision below 3.0%, and the detection limits (S/N=3) of chlorogenic acid, linarin and luteolin were 0.32, 0.08 and 0.05 microg ml(-1), respectively. This assay was successfully applied to the determination of three active phenolic compounds in Flos Chrysanthemi Indici suppository samples with the quantitative recoveries in the range of 94.7-101.8%. The results indicate that the developed HPLC method can be readily utilized as a quality control method for Flos Chrysanthemi Indici suppository and its related traditional Chinese medicinal preparations.

Acetic Acid↗

PubMed2003

In vitro drug liberation and kinetics of sustained release indomethacin suppository.

The aim of this study was to formulate sustained release (SR) suppositories containing indomethacin (IND) microspheres. In the first part of the study, IND microspheres were prepared by solvent evaporation method. Ethyl cellulose was used as polymer. Shape and surface characteristics, particle size and size distribution of microspheres were determined. The effect of drug: polymer ratio and stirring rate on microsphere formation, average particle size, drug loading capacity and in vitro IND release were investigated. The highest drug loading capacity was found with 1:1 drug-polymer ratio. Stirring rate caused insignificant effect on drug loading capacity but particle size. Increase in stirring rate resulted in a decrease in particle size. In the second part, SR suppositories were formulated by incorporating IND microspheres having the highest drug loaded. The bases used were PEG mixtures (400:1500:4000) and Witepsol H15. Qualitative controls and IND assay on the suppositories were carried out. The drugs released were evaluated by in vitro dissolution tests. Comparative results of SR suppositories containing IND microspheres with that of conventional ones showed that the former has sustained effect up to 480 min in vitro. Release results were evaluated kinetically and the data was fitted (Bt)(a) kinetics.

Biological Availability↗

PubMed1983

Effect of the suppository base on progesterone delivery from the vagina.

Inadequate levels of circulating progesterone (P) seen in clinical practice can be increased by P supplementation. When supplementation is via the vaginal route, its presentation may be in many different suppository bases. We have measured circulating P in the follicular phase to compare delivery from the vagina after P was presented in three different bases (glycerinated gelatin, cocoa butter, and polyethylene glycol). The mean peak level achieved and the area under the curve were highest after supplementation from polyethylene glycol-based suppositories. The duration of elevation above baseline was similar with all three suppositories. It is concluded that the suppository base is important in controlling the amount of this steroid absorbed from a given amount presented by this route.

Adolescent↗

PubMed1996

Rectal suppositories of 8-methoxsalen produce fewer gastrointestinal side effects than the oral formulation.

BACKGROUND: Gastrointestinal side effects are associated with the oral ingestion of 8-methoxsalen (8-MOP), including the liquid and crystalline formulations. OBJECTIVE: The objective of this study was to determine whether the gastrointestinal symptoms associated with 8-MOP could be decreased by altering the route of administration. METHODS: In an open pilot study, 8-MOP rectal suppositories were given to six patients with psoriasis vulgaris who had significant nausea or abdominal pain with the oral liquid form of the drug. RESULTS: On a scale of 0 to 5, this group of patients reported a mean score of 4.4 for nausea, 0.3 for vomiting, 2.1 for abdominal pain, and 1.3 for headaches with oral 8-MOP. With the suppository form, the mean scores were 0 for nausea, 0 for vomiting, 0 for abdominal pain, and 0 for headaches. These latter values represent scores for the entire treatment period. Clinical severity scores of psoriasis improved from a mean of 6.5 (maximum possible score = 9) at the start of the trial to a mean of 1 at its conclusion. Plasma 8-MOP levels of more than 100 ng/ml were observed in all patients who received the suppositories; in only one patient were the 8-MOP plasma levels significantly higher with the oral form than with the rectal form. CONCLUSION: Rectal suppositories of 8-MOP were associated with significantly fewer gastrointestinal side effects than the oral form of the drug; this was accomplished without compromising clinical efficacy.

Abdominal Pain↗

PubMed2003

Thermal and rheological study of lipophilic ethosuximide suppositories.

We have performed thermal (differential scanning calorimetry) and rheological studies in the preformulation phase of ethosuximide suppositories to determine the influence of the active ingredient and adjuvants on the melting characteristics and rheological performance of the suppositories. Both types of studies were performed on the fatty bases witepsol H-19 and suppocire AP, each mixed with 5% w/w polysorbate 80, 0.1% w/w docusate sodium and 3% w/w tetranyl AT-1/DP and on the suppository formulations obtained by the addition of 150 mg of ethosuximide to these excipients. Pure lipophilic excipients have two peaks in the DSC curve. The first one occurs at lower temperatures (27.35 degrees C for the suppocire AP and 34.3 degrees C for the witepsol H19) and the second peak at higher temperatures (36.27 and 35.95 degrees C for the suppocire AP and witepsol H19, respectively). Polysorbate 80, docusate sodium and tetranyl AT-1/DP cause the first melting peak to disappear and the second peak to occur at a lower temperature. The thermograms of the formulas show two melting peaks and the endothermic peak does not appear due to the melting of ethosuximide (47.8 degrees C). We attribute this behavior to the solubility of the drug in the melted excipient, thus originating a decrease of the melting temperature of the second peak in the DSC scan. The excipients and formulations behave as Newtonian fluids and the influence of ethosuximide and adjuvants can be noted in an increase in the viscosity of the suppository mass.

Calorimetry, Differential Scanning↗

PubMed1999

Influence of neutron activation factors on the physico-chemical properties of suppositories and their excipients.

The effect of the neutron activation factors, i.e., admixture of samarium oxide (Sm2O3) and irradiation time, on the physico-chemical properties of the raw materials and the in vitro dissolution and disintegration of hydrophilic and lipophilic suppositories was investigated. It was possible to expose the pure bases and the model drugs (5-aminosalicylic acid [5-ASA] and ropivacaine hydrochloride) to 1 min of neutron irradiation in a flux of 1.1.1013 n cm-2s-1. The dissolution and disintegration of the corresponding suppositories showed that the physico-chemical properties and the fraction of incorporated drug together with the lipophilic/hydrophilic nature of the base were important factors. Sm2O3 increased the disintegration time of hydrophilic suppositories containing 5-ASA, while the dissolution of both drugs from these formulations remained unchanged. Sm2O3 did not alter the disintegration time of the lipophilic formulations, but it reduced the dissolution of both drugs from these suppositories. Irradiation induced different behaviour in the different bases.

Amides↗

PubMed2000

Improvement of availability of allopurinol from pharmaceutical dosage forms I - suppositories.

Solid dispersion and crystallization of a very slightly water-soluble drug, allopurinol, were prepared using urea, sodium salicylate and beta-cyclodextrin (beta-CD) as carriers. The spectroscopic infra-red (IR), differential scanning calorimetry (DSC) and powder X-ray diffractometry (PXRD) data indicate a role of these carriers in decreasing the crystallinity of allopurinol and complexing abilities. Solid dispersion and crystallization of the drug with these carriers were used in suppository formulations to investigate their role in enhancement of drug release through the membrane barrier. The bases used included Suppocire AM and the mixture of polyethylene glycols (PEGs). The release rates of allopurinol from lipophilic and hydrophilic suppository bases were examined and compared with those obtained for their inclusion compounds incorporated in the same bases. The prepared suppositories were evaluated for in-vitro drug release, when fresh and on storage. The release of pure allopurinol from the lipophilic base was remarkably higher than that from the hydrophilic one. The release of allopurinol from lipophilic as well as hydrophilic bases was significantly enhanced by crystallization of the drug from 5% w/v of sodium salicylate. Allopurinol crystallized from sodium salicylate, showed enhanced release reaching about 100% in 1 h from the Suppocire AM base. The obtained data from these experiments proved the superiority of the PEG formulations containing coevaporates of the drug to sodium salicylate, ratio 1:1, or of the drug to beta-CD, ratio 1:2; T(90%),12 and 36 min, respectively. A significant decrease of uric acid excretion in rabbits was observed after rectal administration of suppositories containing allopurinol crystallized from sodium salicylate.

Allopurinol↗

PubMed1997

Efficacy and tolerance of mesalazine suppositories vs. hydrocortisone foam in proctitis.

BACKGROUND: Topical treatments with steroids or mesalazine are the most effective treatments for idiopathic proctitis. AIM: To compare the efficacy and tolerance of mesalazine suppositories vs. hydrocortisone acetate foam in the treatment of acute proctitis. PATIENTS AND METHODS: 242 patients with active idiopathic proctitis were randomized to receive once daily either one Pentasa suppository (mesalazine 1 g) or 100 mg hydrocortisone (Colofoam) for 14-21 days (until remission). Disease activity and tolerance of the treatments were assessed using a daily questionnaire, by physician assessment, and endoscopy score. RESULTS: Both treatments induced a significant reduction in disease activity. Mesalazine suppositories were significantly more effective than hydrocortisone on rectal blood loss (P = 0.002) and mucus (P = 0.02) parameters, and on the degree of the decrease in endoscopy score (P = 0.02). No significant difference was observed between treatments concerning histology or tolerance. CONCLUSION: Mesalazine suppositories were as well-tolerated as hydrocortisone foam, but were more effective for some parameters of disease activity.

Acute Disease↗

PubMed2001

Anaphylaxis to gelatin-containing rectal suppositories.

BACKGROUND: Some children--though the number is few-have been sensitized with gelatin. OBJECTIVE: To investigate the relationship between the presence of antigelatin IgE and anaphylaxis to gelatin-containing rectal suppository, we measured antigelatin IgE in the sera of the children with anaphylaxis. METHODS: Ten children showed systemic allergic reactions, including anaphylaxis, to a chloral hydrate rectal suppository containing gelatin (231 mg/dose) that had been used as a sedative. These children's clinical histories and serum samples were submitted from physicians to the National Institute of Infectious Diseases during a 2-year period from 1996 to 1997. RESULTS: Of the 10 children, 5 showed apparent anaphylaxis, including hypotension and/or cyanosis, along with urticaria or wheezing; 2 showed both urticaria and wheezing without hypotension or cyanosis; the other 3 showed only urticaria. All of the children had antigelatin IgE (mean value +/- SD, 7.9 +/- 8.4 Ua/mL). As a control, samples from 250 randomly selected children had no antigelatin IgE. These findings suggest that the 10 children's systemic allergic reactions to this suppository were caused by the gelatin component. CONCLUSION: Gelatin-containing suppositories must be used with the same caution as gelatin-containing vaccines and other medications.

Anaphylaxis↗

PubMed1995

Efficacy and tolerability of a sequential, artesunate suppository plus mefloquine, treatment of severe falciparum malaria.

Thirty patients with severe falciparum malaria were each given a total of 1600-mg artesunate suppository over three consecutive days followed by 1250 mg mefloquine per os, divided into two doses which were given 12 h apart. All patients were admitted for 28 days to the Bangkok Hospital for Tropical Diseases, so that the efficacy and tolerability of the treatment could be assessed. All the patients showed clinical improvement, with mean (S.D.) parasite and fever clearance times of 50.4 (13.0) and 70.7 (44.9) h, respectively. Two patients with unrousable coma (Glasgow coma score < or = 8) on admittance regained consciousness 46 and 48 h post-treatment. One other patient had acute renal failure and required dialysis. Most patients (80%) were initially hyperparasitaemic, with a mean density of 184,344 parasites/microliters blood. No deaths occurred. Efficacy was evaluated in 25 of the patients. The cure rate 28 days post-treatment was 92%. None of the patients had major adverse effects although two had tenesmus and passed stools immediately after each suppository was administered. A fresh suppository had to be inserted when this occurred. The results indicate that artesunate suppositories followed by oral mefloquine constitute a well-tolerated regimen with a high cure rate. The combination is suitable as an alternative treatment for severe malaria, particularly in children. Further, large-scale studies are required.

Adolescent↗